For other versions of this document, see http://wikileaks.org/wiki/CRS-RL34614 ------------------------------------------------------------------------------ Order Code RL34614 Nanotechnology and Environmental, Health, and Safety: Issues for Consideration August 6, 2008 John F. Sargent Specialist in Science and Technology Policy Resources, Science, and Industry Division Nanotechnology and Environmental, Health, and Safety: Issues for Consideration Summary Nanotechnology -- a term encompassing nanoscale science, engineering, and technology -- is focused on understanding, controlling, and exploiting the unique properties of matter that can emerge at scales of one to 100 nanometers. A key issue before Congress regarding nanotechnology is how best to protect human health, safety, and the environment as nanoscale materials and products are researched, developed, manufactured, used, and discarded. While the rapidly emerging field of nanotechnology is believed by many to offer significant economic and societal benefits, some research results have raised concerns about the potential adverse environmental, health, and safety (EHS) implications of nanoscale materials. Some have described nanotechnology as a two-edged sword. On the one hand, some are concerned that nanoscale particles may enter and accumulate in vital organs, such as the lungs and brains, potentially causing harm or death to humans and animals, and that the diffusion of nanoscale particles in the environment might harm ecosystems. On the other hand, some believe that nanotechnology has the potential to deliver important EHS benefits such as reducing energy consumption, pollution, and greenhouse gas emissions; remediating environmental damage; curing, managing, or preventing diseases; and offering new safety-enhancing materials that are stronger, self-repairing, and able to adapt to provide protection. Stakeholders generally agree that concerns about potential detrimental effects of nanoscale materials and devices -- both real and perceived -- must be addressed to protect and improve human health, safety, and the environment; enable accurate and efficient risk assessment, risk management, and cost-benefit trade-offs; foster innovation and public confidence; and ensure that society can enjoy the widespread economic and societal benefits that nanotechnology may offer. Congressionally-mandated reviews of the National Nanotechnology Initiative (NNI) by the National Research Council and the President's Council of Advisors on Science and Technology have concluded that additional research is required to make a rigorous risk assessment of nanoscale materials. Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Opportunities and Challenges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Importance of Addressing EHS Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Selected Issues for Consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Federal Investment in EHS Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Current Funding Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Alternative Approaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Management of Federal EHS Research . . . . . . . . . . . . . . . . . . . . . . . . 17 Federal Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 International Engagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Concluding Observations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Nanotechnology EHS-Related Legislation in the 110th Congress . . . . . . . . . . . . 29 H.R. 5940 -- National Nanotechnology Initiative Amendments Act of 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 S. 3274 -- National Nanotechnology Initiative Amendments Act of 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 H.R. 3235 -- Nanotechnology Advancement and New Opportunities Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 H.R. 4040 -- CPSC Reform Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Appendix A. Selected Nanotechnology EHS Activities of Federal Regulatory Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Appendix B. Selected International Engagement Efforts of NNI Agencies . . . . 41 List of Tables Table 1. NNI Environmental, Health, and Safety Research Funding, FY2006-2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 2. FY2006 NNI Funding for EHS Research by Research Needs Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Nanotechnology and Environmental, Health, and Safety: Issues for Consideration Introduction Nanotechnology -- a term encompassing nanoscale science, engineering, and technology -- is focused on understanding, controlling, and exploiting the unique properties of matter that can emerge at scales of one to 100 nanometers.1 These properties are believed by many to offer substantial economic and societal benefits. A key issue before Congress regarding nanotechnology is how best to protect human health, safety, and the environment as nanoscale materials and products are researched, developed, manufactured, used, and discarded. While the rapidly emerging field of nanotechnology is believed by many to offer significant economic and societal benefits, some research results have raised concerns about the potential environmental, health, and safety (EHS) implications of nanoscale materials. Potential tools the Federal government might use to address these concerns include research and development, regulation, and international engagement. Some of the properties of nanoscale materials (e.g., small size, high surface area-to-volume ratio) that have given rise to great hopes for beneficial applications have also given rise to concerns about their potential adverse implications for the environment, and human health and safety.2 There are more than 600 nanotechnology products reportedly commercially available,3 and with this number of products concerns have been raised about the health and safety of the scientists working with nanoscale materials, workers who manufacture the products, consumers who use the products, and members of the general public who may be exposed to 1 Congress defined nanotechnology in the 21st Century Nanotechnology Research and Development Act (P.L. 108-153) as, "the science and technology that will enable one to understand, measure, manipulate, and manufacture at the atomic, molecular, and supramolecular levels, aimed at creating materials, devices, and systems with fundamentally new molecular organization, properties, and functions." ASTM International, one of the largest voluntary standards development organizations, has defined nanotechnology as, "A term referring to a wide range of technologies that measure, manipulate, or incorporate materials and/or features with at least one dimension between approximately 1 and 100 nanometers. Such applications exploit those properties, distinct from bulk or molecular systems, of nanoscale components." One nanometer is about the width of 10 hydrogen atoms placed side-by-side, or approximately 1/100,0000 of the thickness of a sheet of paper. 2 Nanotechnology EHS applications refers to the beneficial use of nanotechnology to improve health, safety and the environment; EHS implications refers to known and potential adverse effects of nanoscale materials on health, safety and the environment. 3 Project on Emerging Nanotechnologies. Figure as of April 2008. CRS-2 nanoparticles, as well as the environmental impact of nanomanufacturing processes and the use and disposal of nanotechnology products. Nanoscale particles can result from a variety of different processes. While nanoscale particles can occur naturally (e.g., some particles produced by forest fires, sea spray, volcanoes) and as an incidental by-product of human activities (e.g., some particles contained in welding fumes, diesel exhaust, industrial effluents, cooking smoke), EHS concerns have focused primarily on nanoscale materials that are intentionally designed and produced, often referred to as engineered nanomaterials. Issues surrounding the potential EHS implications of nanotechnology emerged with the launch in 2000 of the National Nanotechnology Initiative (NNI). The NNI is a multi-agency federal effort to coordinate and expand federal nanotechnology research and development (R&D) efforts. Between FY2001 and FY2008, the federal government invested $8.4 billion in nanotechnology R&D. Many governments around the world have followed the U.S. lead and established their own national nanotechnology programs. The private sector has invested heavily as well. Global nanotechnology R&D investments -- public and private -- are estimated to have totaled $12.4 billion in 2006 alone.4 Such large investments and intensified efforts to capitalize on these public and private investments have caused some observers (as detailed later in this report) to suggest that there is insufficient information about the potential effects nanotechnology products and manufacturing processes may have on human health, safety, and the environment. They assert a variety of uncertainties, including: how nanoscale particles might be transported in air, water, and soil; how they might react with the environment chemically, biologically, or through other processes; how they might be distributed and deposited; and whether they might accumulate in plants or animals. Others express the view that concerns about nanotechnology EHS implications are often overgeneralized and overstated. Among the arguments they put forth are that nanoscale materials are frequently embedded in other materials as part of the manufacturing process; that some nanotechnology products, such as semiconductors, have nanoscale features but do not contain nanoscale particles; that nanotechnology materials may replace other materials that have significant and known risks; that some nanoscale particles tend to aggregate or agglomerate in the environment into larger particles that no longer have nanoscale dimensions; and that people are regularly exposed to nanoscale particles produced naturally and as incidental by- products of human activities. Congressionally-mandated reviews of the NNI by the National Research Council (NRC) and the President's Council of Advisors on Science and Technology (PCAST) have concluded that additional research is required to make a rigorous risk assessment of nanoscale materials. In addition, the NRC warned that, until such information is available, precautionary measures should be taken to protect the health and safety of workers, the public, and the environment. 4 Profiting From International Nanotechnology, Lux Research, December 2006. CRS-3 Nevertheless, most stakeholders agree that these concerns about the potential detrimental effects of nanoscale materials and devices -- both real and perceived -- must be addressed. Among the issues these stakeholders have identified are characterizing the toxicity of nanoscale materials; developing methods for assessing and managing the risks of these materials; and understanding how these materials move in, and interact with, the environment. This report identifies the potential environmental, health, and safety opportunities and challenges of nanotechnology; explains the importance of addressing nanotechnology EHS concerns; identifies and discusses nanotechnology EHS issues; and summarizes options for Congressional action, including the nanotechnology EHS-related provisions of selected legislation. The report also includes two appendices. Appendix A provides an overview of selected nanotechnology EHS activities of federal regulatory agencies. Appendix B provides an overview of selected EHS-related international engagement efforts of NNI agencies. For more information on the NNI see, CRS Report RL34401, The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, by John F. Sargent. For additional information on nanotechnology-related regulatory challenges, see CRS Report RL34332, Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, by Linda-Jo Schierow. Opportunities and Challenges Historically, many new technologies have delivered general societal benefits while presenting EHS challenges. For example, automobiles increased personal mobility and provided faster, less expensive transportation of goods, but soon became a leading cause of accidental deaths and injuries, as well as a source of emissions that can damage air quality and may contribute to global climate change. Similarly, genetically-modified (GM) plants have traits such as greater resistance to pests, pesticides, or cold temperatures that contribute to higher crop yields, while critics argue some GM foods contribute to food allergies and antibiotic resistance.5 Like other new technologies, nanotechnology offers potential economic and societal benefits, and presents potential EHS challenges as well. Nanotechnology advocates assert, however, that nanotechnology provides the opportunity to reduce or eliminate known risks by engineering around them. Proponents maintain that nanotechnology also offers the potential for significant EHS benefits, including: ! reducing energy consumption, pollution, and greenhouse gas emissions; ! cleaner, more efficient industrial processes; ! remediating environmental damage; ! curing, managing, or preventing deadly diseases; and 5 "Genetically Modified Crops and Foods," Friends of the Earth, January 2003. [http://www.foe.co.uk/resource/briefings/gm_crops_food.pdf] CRS-4 ! offering new materials that protect against Potential Nanotechnology impacts, self-repair to Cancer Applications prevent catastrophic failure, or change in ways that protect or aid The NCI Cancer Nanotechnology Plan asserts that nanotechnology can soldiers on the serve as an enabling technology for a battlefield. variety of cancer-related applications: For example, nanoscale materials ˇ imaging agents and diagnostics that allow clinicians to detect cancer in show promise for detecting, preventing, its earliest, most easily treatable, and removing pollutants. According to pre-symptomatic stage; the Environmental Protection Agency ˇ systems that provide real-time (EPA): assessments of therapeutic and surgical efficacy; nanoscale cerium oxide has been ˇ multifunctional, targeted devices developed to decrease diesel capable of bypassing biological engi ne emissi ons; iron barriers to deliver therapeutic agents nanoparticles can remove at high local concentrations directly contaminants from soil and to cancer cells and tissues that play ground water; and nano-sized a critical role in the growth and sensors hold promise for metastasis of cancer; improved detection and tracking of contaminants.6 ˇ agents capable of monitoring predictive molecular changes and preventing precancerous cells from In the area of human health, becoming malignant; scientists assert nanotechnology has the ˇ surveillance systems that detect potential for improving disease mutations that may trigger the diagnostics, sensing, monitoring, cancer process and genetic markers assessment, and treatment. In particular, that indicate a predisposition for the National Cancer Institute (NCI) views cancer; nanotechnology as likely to provide ˇ novel methods for managing the revolutionary tools to extend and improve symptoms of cancer that adversely lives. In July 2004, NCI launched a impact quality of life; and five-year, $145 million initiative focused ˇ research tools that enable on applying nanotechnology to the investigators to quickly identify new prevention, detection, and treatment of targets for clinical development and cancer and amelioration of its symptoms. predict drug resistance. At the initiative's launch, then-NCI Source: Cancer Nanotechnology Plan: A Director Andrew von Eschenbach Strategic Initiative to Transform Clinical identified nanotechnology as a key Oncology and Basic Research Through the component of the agency's strategy for Directed Application of Nanotechnology, ending death and suffering from cancer National Cancer Institute, National Institutes of Health, Department of Health and Human Services, July 2004. 6 "Fact Sheet for Nanotechnology under the Toxic Substances Control Act," Environmental Protection Agency. [http://www.epa.gov/oppt/nano/nano-facts.htm] CRS-5 by 2015 (see text box, "Potential Nanotechnology Cancer Applications").7 Some characteristics of nanoscale particles could produce both positive and negative consequences. According to E. Clayton Teague, director of the National Nanotechnology Coordination Office (NNCO), the unique properties of these [nanotechnology] materials are a double-edged sword: they can be tailored for beneficial properties, but also have unknown consequences, such as new toxicological and environmental effects.8 The following examples illustrate how the same nanotechnology material may be both potentially beneficial and potentially harmful: ! Nanoscale silver is highly effective as an antibacterial agent in wound dressings, clothing, and washing machines, but some have expressed concerns that widespread dispersion of nanoscale silver in the environment could kill microbes that are vital to waste water treatment plants and to ecosystems. Some beneficial bacteria, for example, break down organic matter, remove nitrogen from water, aid in animal digestion, protect against fungal infestations, and even aid some animals in defense against predators.9 ! Some nanoscale particles may have the potential to penetrate the blood-brain barrier, a structure that protects the brain from harmful substances in the blood but also hinders the delivery of therapeutic agents. The characteristics of certain nanoscale materials may allow pharmaceuticals to be developed to purposefully and beneficially cross this barrier and deliver medicine directly to the brain to treat, for example, a brain tumor.10 Some critics are concerned, however, that nanoscale particles might unintentionally pass through the blood-brain barrier causing harm to humans and animals.11 ! Certain nanoscale materials are highly chemically reactive due to their high surface-to-volume ratio.12 This is a property that might be 7 "Cancer Nanotech Plan Gets Nod of Approval," Science, Vol. 305, July 23, 2004. [http://www.sciencemag.org/content/vol305/issue5683/s-scope.dtl#305/5683/461c] 8 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p. 148. 9 Nanosilver: A Threat to Soil, Water and Human Health? Friends of the Earth, March 2007. [http://www.foe.org/pdf/FoE_Australia_Nanosilver_report.pdf] 10 "Blood-Brain Barrier Breached by New Therapeutic Strategy," press release, National Institutes of Health, June 2007. [http://www3.niaid.nih.gov/news/newsreleases/2007/ bloodbrainbarrier.htm] 11 "Nanotechnology Risks: How Buckyballs Hurt Cells," Science Daily, May 27, 2008. [http://www.sciencedaily.com/releases/2008/05/080527091910.htm] 12 National Nanotechnology Initiative: Research and Development Supporting the Next (continued...) CRS-6 positively exploited in catalysis, treatment of groundwater contamination, and site remediation. This property also is being explored for use in protective masks and clothing as a defense against chemical and biological agents. However, some research results indicate that the reactivity of some nanoparticles potentially can result in cell damage in animals.13 ! Carbon nanotubes (CNTs) have potential uses in a wide range of applications (e.g., materials, batteries, memory devices, electronic displays, transparent conductors, sensors, medical imaging). However, some scientists have expressed concerns that some CNTs exhibit properties similar to asbestos fibers, and might become lodged in organs (e.g., lungs), harming humans and animals.14 12 (...continued) Industrial Revolution, Supplement to the President's FY2004 Budget, Nanoscale Science, Engineering and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, October 2003. [http://www.nano.gov/nni04_budget_supplement.pdf] 13 Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L. "Cellular Toxicity of Carbon-Based Nanomaterials," Nano Letters, 6(6):1121-1125, American Chemical Society, May 2006. [http://pubs.acs.org/ cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.htmll] 14 Nanotechnology: The Future is Coming Sooner Thank You Think, Joint Economic Committee, U.S. Congress, March 2007. p. 13. [http://www.house.gov/jec/publications/110/ nanotechnology_03-22-07.pdf] CRS-7 EHS Concerns About Carbon Nanotubes and Other Fullerenes Much of the public dialogue about potential risks associated with nanotechnology has focused on carbon nanotubes (CNTs) and other fullerenes (molecules formed entirely of carbon atoms in the form of a hollow sphere, ellipsoid, or tube) since they are currently being manufactured and are among the most promising nanomaterials. These concerns have been amplified by some research on the effects of CNTs on animals and on animal and human cells. For example, researchers have reported that carbon nanotubes inserted into the trachea of mice can cause lung tissue damage;a that buckyballs (spherical fullerenes) caused brain damage in fish;b and that buckyballs can accumulate within cells and potentially cause DNA damage.c There are scientists who have argued that experiments indicating CNT/fullerene toxicity are not conclusive. They suggest that toxicity reported by researchers may have resulted from uncharacterized contaminants in the samples resulting from the synthesis, purification, and post-processing methods used in the manufacture of CNTs. Thus, they assert, the experiments could be measuring the toxicity of non-nanoscale materials and, therefore, unfairly indicting nanoscale materials. They also contend that such non-nanoscale contaminants, if identified as toxic, potentially could be eliminated or controlled in the manufacturing process. The issue of contaminants is often cited by advocates for improved standards, reference materials, sensors, instrumentation, and other technologies for the characterization of nanoscale materials. Some experiments have produced results that indicate CNTs/fullerenes are non-toxic. Research on single-walled carbon nanotubes (SWCNTs) by the Institute of Toxicology and Genetics in Karlsruhe, Germany, reported that, in three of four different types of tests conducted, SWCNTs did not show toxicity. In the fourth test, which appeared to indicate SWCNT toxicity, the researchers concluded that the results were a "false positive" and explained how the SWCNTs interacted with the materials in the assay to produce a misleading result. These researchers concluded that this result points to the need for careful selection of assays and the need for the establishment of standards for toxicity testing of CNTs and other nanomaterials.d Work at Rice University's Center for Biological and Environmental Nanotechnology conducted in 2005 found cell toxicity of CNTs to be low, and that it could be reduced further through simple chemical changes to the surface.e Earlier research demonstrated that similar surface modifications of buckyballs reduced their toxicity. Nanotechnology may offer the potential to engineer around known and potential hazards by changing the size, molecular construction, or other property of a nanoscale material to make it safe or less hazardous. Experts advise that the potential to do so will require a thorough understanding of the properties of the various nanoparticles and their effects on humans and other organisms. a Lam, C.W., James, J.T., McCluskey, R., and Hunter, R.L. "Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation," September 2003. [http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14514958] b Oberdörster, Eva. "Manufactured Nanomaterials (Fullerenes, C60) Induce Oxidative Stress in the Brain of J u v e n i l e La r g e mo u t h B a s s , " A p r i l 2 0 0 4 . [ h t t p : / / www. p u b me d c e n t r a l . n i h . go v/ articlerender.fcgi?tool=pmcentrez&artid=1247377] c Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L. "Cellular Toxicity of Carbon-Based Nanomaterials," Nano Letters, 6(6):1121-1125, American Chemical Society, May 2006. [http://pubs.acs.org/cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.html] d Wörle-Knirsch, J.M., Pulskamp, K., and Krug, H. F. "Oops They Did It Again! Carbon Nanotubes Hoax Scientists in Viability Assays," American Chemical Society, Nano Letters, Vol.6, April 2006. e "Modifications render carbon nanotubes nontoxic," press release, Rice University, October 2005. CRS-8 Importance of Addressing EHS Issues Nanotechnology covers a wide swath of scientific fields, engineering disciplines, and technological applications. Sufficient knowledge has been developed about the useful properties of certain nanomaterials, how they can be manufactured, and how they can be applied in useful ways to enable commercial product development. In other areas of nanotechnology, fundamental research on nanoscale phenomena and processes is under way that may lead to greater understanding and beneficial applications in the years ahead. In general, however, nanotechnology is still an emerging field and there is a dearth of information about how nanoscale particles and devices might adversely affect human health, safety, and the environment. Accordingly, there is widespread agreement on the need for more research to better understand such implications. In reviews of the NNI,15 both the National Research Council and the President's Council of Advisors on Science and Technology (PCAST) concluded that assessment of potential nanotechnology EHS risks is not possible due to the absence of information and tools. According to the NRC, it is not yet possible to make a rigorous assessment of the level of risk posed by [engineered nanomaterials]. Further risk assessment protocols have to be developed, and more research is required to enable assessment of potential EHS risks from nanomaterials.16 Similarly, PCAST concluded that it is premature to rigorously assess the levels of risk posed by engineered nanomaterials. Adequate tools are being developed but are not yet in place.17 Leaders of the NNI have argued strongly that to achieve the economic, societal, and EHS benefits of nanotechnology the nation must concurrently address its potential adverse effects. According to then-Under Secretary of Commerce for Technology Phillip J. Bond, a leading Administration advocate for the NNI, 15 The 21st Century Nanotechnology Research and Development Act (P.L. 108-153) requires a triennial assessment of the National Nanotechnology Program (in practice, of the NNI) by the NRC and a biennial assessment by PCAST, serving in its capacity as the National Nanotechnology Advisory Panel (NNAP). The act requires each assessment to include a review of the NNI's EHS activities. Three such assessments have been conducted, one by the NRC (A Matter of Size: Triennial Review of the National Nanotechnology Initiative, 2006) and two by PCAST (The National Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National Nanotechnology Advisory Panel, May 2005; The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, April 2008). 16 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p. 90. 17 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. p. 7. CRS-9 Addressing societal and ethical issues is the right thing to do and the necessary thing to do. It is the right thing to do because as ethically responsible leaders we must ensure that technology advances human well-being and does not detract from it. It is the necessary thing to do because it is essential for speeding technology adoption, broadening the economic and societal benefits, and accelerating and increasing our return on investment.18 This is a view shared by many in the business community. A 2006 survey of business leaders in the field of nanotechnology indicated that nearly two-thirds believe that "the risks to the public, the workforce, and the environment due to exposure to nano particles are `not known,'" and 97% believe that it is very important or somewhat important for the government to address potential health effects and environmental risks that may be associated with nanotechnology.19 The Project on Emerging Nanotechnologies (PEN) has warned that bad practices in nanotechnology research or production may result in a nanotechnology accident that would chill investment, galvanize public opposition, and generally lead to a lot of hand wringing on the part of governments who are betting large sums of money on the nanotech revolution.20 Successfully addressing EHS issues is seen as vital for those potentially exposed to nanoscale materials (e.g., consumers, researchers, manufacturing workers, the general public), businesses, and investors for a variety of reasons: ! protecting and improving human health, safety, and the environment; ! enabling accurate and efficient risk assessments, risk management, and cost-benefit trade-offs; ! ensuring public confidence in the safety of nanotechnology research, engineering, manufacturing, and use; ! preventing a problem in one application area of nanotechnology from having negative consequences for the use of nanotechnology in unrelated application areas due to public fears, legislative interventions, or an overly-broad regulatory response; and ! ensuring that society can enjoy the widespread economic and societal benefits that nanotechnology is believed by many to offer. 18 Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. "Preparing the Path for Nanotechnology: Addressing Legitimate Societal and Ethical Issues," keynote address, Nanoscale Science, Engineering, and Technology Subcommittee Workshop on Societal Implications of Nanoscience and Nanotechnology, December 3, 2003. 19 "Survey of U.S. Nanotechnology Executives," Small Times Magazine and the Center for Economic and Civic Opinion at the University of Massachusetts-Lowell, Fall 2006. 20 Rejeski, David, Director, Project on Emerging Nanotechnologies. "Nanotech Safety 101 or How to Avoid the Next Little Accident," paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006. [http://www.nanotechproject.org/file_download/files/ nanotechsafety101paper.pdf] CRS-10 In addition, the U.S. regulatory environment for nanotechnology could be an enabler for innovation and contribute to a strong, sustainable economy by creating predictability, accurately assessing risks and benefits, and fostering the swift movement of safe products into the market. Such an environment is likely to favor nanotechnology-related investments and innovative activities in the United States by domestic and foreign stakeholders, as opposed to nations where such regulatory conditions do not exist. Conversely, if the U.S. regulatory environment is not handled effectively (i.e., if it lacks predictability, if regulatory approaches do not accurately assess risks and benefits, or if approval processes are too long or expensive) it could prove a major impediment to innovation, economic growth, and job creation, as well as posing a potential threat to health, safety, and the environment. In such a regulatory environment, investment capital may be driven away from nanotechnology, potentially beneficial products may not be developed, safe products may be denied regulatory approval, or unsafe products may be allowed to enter the market. Alternatively, nanotechnology investments, research, and production may be driven to other nations with preferable regulatory environments. On the one hand, such a regulatory system might be more desirable to investors and companies because it is more predictable, more efficient, and less costly. In such a case, the United States might miss out on nanotechnology's potential economic benefits. On the other hand, if other nations' regulatory systems are more attractive to investors and producers because those systems under-regulate or do not regulate at all, then nanotechnology research, development, and production could present increased EHS risks worldwide. Selected Issues for Consideration Given the widespread agreement that nanotechnology EHS concerns must be addressed, discourse on how best to do so has focused on three main issues: ! federal investment in EHS research; ! federal regulation; and ! international engagement. These issues are closely interrelated. For example, reliable EHS research is required by regulatory bodies to determine whether and how to regulate nanotechnology products. Since all nations face the same fundamental health, safety, and environmental issues, international coordination on EHS research could help accelerate development of a common body of knowledge through the sharing of results and reduction in redundant research. This shared knowledge could, in turn, inform regulatory decision making and perhaps improve the consistency of regulations among nations. Regulations, standards, and enforcement might need to be coordinated worldwide to protect workers and consumers as intermediate and final products are frequently produced along global supply chains and sold in industrial and commercial markets around the world. In addition, one nation's policies governing nanotechnology production, use, and disposal may have implications for nearby nations and, perhaps, for all nations. CRS-11 Federal Investment in EHS Research Current Funding Level. There is not a single, centralized source of EHS research funds that is allocated to individual agencies. Agency nanotechnology budgets are developed internally as part of each agency's overall budget development process. These budgets are subjected to review, revision, and approval by the Office of Management and Budget (OMB) and become part of the President's annual budget submission to Congress. The NNI budget -- and the EHS component -- is then calculated by aggregating the nanotechnology components of the appropriations provided by Congress to each federal agency. While there is some coordination of EHS-research budget requests through the Nanotechnology Environmental and Health Implications (NEHI) working group21 and in OMB's budget development process, the decision process that establishes overall funding for nanotechnology EHS research is highly decentralized. In FY2008, NNI funding for EHS implications research22 is $58.6 million, approximately 3.9% of the total NNI budget of $1.49 billion. This represents an increase over the FY2007 EHS research level of $48.3 million (3.4% of the total NNI budget), and the FY2006 level of $37.7 million (2.8%), both in dollars and in share of total NNI funding. President Bush has requested $76.4 million (5.0%) for EHS research in FY2009. NNI EHS research funding for FY2006 through FY2008, and the request for FY2009, is provided in Table 1. Table 1. NNI Environmental, Health, and Safety Research Funding, FY2006-2008 EHS research, EHS research's share in current dollars of total NNI budget FY2006 (actual) $ 37.7 million 2.8% FY2007 (actual) 48.3 million 3.4% FY2008 (estimated) 58.6 million 3.9% FY2009 (requested) 76.4 million 5.0% Sources: "The National Nanotechnology Initiative: Research and Development Leading to a Revolution in Technology and Industry, Supplement to the President's FY2008 Budget," NSET Subcommittee, NSTC, OSTP, The White House, July 2007; "National Nanotechnology Initiative: FY2009 Budget and Highlights," NSET Subcommittee, NSTC, The White House, February 2008. [http://www.nano.gov/NNI_FY09_budget_summary.pdf] 21 NEHI is a working group of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the White House National Science and Technology Council (NSTC). The NSET Subcommittee is the coordinating body for the NNI. For additional information about the structure of the NNI, see CRS Report RL34401, The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues. 22 According to the NNCO, EHS research funding data included in Tables 1 and 2 of this report are for implications research only. The NNCO also states that the figures reported in Table 1 may understate the NNI's EHS implications research by excluding funding for instrument research, metrology, and standards that support EHS implications research but are reported separately. (Source: Private communication between the NNCO and CRS.) CRS-12 NNI officials assert that the initiative also conducts EHS research as a part of its other research activities, but that these EHS investments are not easily quantified and thus are not reflected in the NNI's reported figure for EHS funding. PCAST agreed with this assertion in its 2008 assessment, arguing that In many instances, nanotechnology EHS research cannot be separated from the particular application(s) research and from the context for which a specific nanomaterial is intended. Such division is unproductive and neglects the whole benefit of research. Consequently, [PCAST] expects that a substantial fraction of nanotechnology research related to EHS will continue to take place under the auspices of agencies that fund applications R&D and may not be uniquely or exclusively identified as nanotechnology EHS research.... Furthermore, detailed reporting on the degree of relevance to EHS of such research is not necessarily critical to (and may actual hinder) overall prioritization and coordination.23 In 2007, OMB issued a one-time request to all NNI research agencies to report funding data on research related to the five categories identified in the NSET document, Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials.24 Totals for EHS implications research spending identified in each of the five categories is shown below in Table 2. Preliminary analysis of this data by the NEHI working group indicated that $67 million was spent on EHS research in FY2006, in contrast to the reported figure of $37.7. Table 2. FY2006 NNI Funding for EHS Research by Research Needs Categories Category Estimated Funding Instrumentation, Metrology, and Analytical Methods $27 million Nanomaterials and Human Health $24 million Nanomaterials and the Environment $13 million Health and Environmental Exposure Assessment $ 1 million Risk Management Methods $ 3 million TOTAL $67 million Note: Numbers may not add due to rounding. Source: Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative." 110th Cong., 1st Sess., October 31, 2007. 23 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. p. 34. 24 Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, August 2007. CRS-13 Critics (as detailed in the following section) assert that the current level of federal nanotechnology EHS research is too low and represents too small a share of the overall NNI budget. These critics argue that the current allocation of NNI funding may produce a flood of products for which there is inadequate information to assess and manage their EHS risks. However, executive branch officials stress that the United States leads the world in EHS funding and, by inference, that the current funding level is adequate. White House Office of Science and Technology Policy (OSTP) director John Marburger asserted that the United States leads the world not only in spending for nanotechnology development, but also, by an even larger margin, in its investment in research to understand the potential health and safety issues.25 Similarly, NNCO director E. Clayton Teague asserted U.S. leadership in nanotechnology EHS research: During fiscal years 2005 through 2008, it is estimated that NNI agencies will have invested nearly $180 million in research whose primary purpose is to address the EHS implications of nanomaterials. With these investments, the United States leads all other countries by a wide margin in support of such research.26 Dr. Teague maintains that EHS research has been a top priority of the Administration and the NNI, citing, as an example, the annual R&D budget guidance memorandum sent by the directors of OMB and OSTP to departments and agencies. This memorandum identifies Administration priorities and is intended to help guide agency budget development for the following fiscal year. The OMB/OSTP memorandum to guide FY2006 agency budget development stated that In order to ensure that nanotechnology research leads to the responsible development of beneficial applications, agencies also should support research on the various societal implications of the nascent technology. In particular, agencies should place a high priority on research on human health and environmental issues related to nanotechnology and develop, where applicable, cross-agency approaches to the funding and execution of this research.27 25 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, September 2006. Cover letter. 26 Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative." 110th Cong., 1st Sess., October 31, 2007. 27 "Updated Administration Research and Development Budget Priorities," memorandum, Office of Management and Budget and Office of Science and Technology Policy, The White House, August 12, 2004. [http://www.whitehouse.gov/omb/memoranda/fy04/m04-23.pdf] CRS-14 The OMB/OSTP memorandum has included similar language in each succeeding year. In their reviews of the NNI, both the NRC and PCAST concluded that federal EHS research funding should be expanded. According to the NRC assessment, To help ensure the responsible development of nanotechnology ... research on the environmental, health, and safety effects of nanotechnology [should] be expanded.28 PCAST acknowledged potential EHS risks in its first review of the NNI but found the federal government was "directing appropriate attention" and "adequate resources" to EHS research. In its second assessment, PCAST termed the current federal investment level in EHS "appropriate," but added that expanded EHS research, broad-based protocol development, and particularly standardization are necessary .... the funding level for EHS [should] continue to grow consistent with the needs identified in the NNI research strategy for nanotechnology EHS as well as the available capacity for quality research.29 Alternative Approaches. Various alternatives have been suggested for addressing the perceived shortcoming in EHS funding. One recommendation is requiring a fixed percentage of the NNI's total funding be devoted to EHS research. A figure of 10% has been proposed for this purpose by organizations such as the NanoBusiness Alliance and the Project on Emerging Nanotechnologies. If this proposal had been in effect in FY2008, the NNI would have been required to spend $149 million on EHS research, more than twice as much as the NSET-reported level of $58.6 million. In testimony before the House Committee on Science and Technology, Sean Murdock, executive director of the NanoBusiness Alliance, agreed with the level of funding represented by the 10% figure but argued the need for cross- agency flexibility in achieving it: The NanoBusiness Alliance believes that environmental, health, and safety research should be fully funded and based on a clear, carefully-constructed research strategy. While we believe that 10 percent of the total funding for nanotechnology research and development is a reasonable estimate of the resources that will be required to execute the strategic plan, we also believe that actual resource levels should be driven by the strategic plan as they will vary significantly across agencies.30 28 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p. 92. 29 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. pp. 7, 27. 30 Murdock, Sean, executive director, NanoBusiness Alliance. Testimony before the Committee on Science and Technology, U.S. House of Representatives. Hearing on "The National Nanotechnology Initiative Amendments Act of 2008." 110th Cong., 2nd Sess., April 16, 2008. CRS-15 Others have suggested a different approach, proposing fixed dollar amounts or minimum levels. For example, the Environmental Defense Fund has called for $100 million or more in federal nanotechnology EHS research funding.31 In its 2008 assessment, PCAST disagreed with both approaches: growing research in nanotechnology EHS must be strategic, guided by ... a comprehensive set of scientifically determined priorities and needs rather than arbitrary percentages or funding figures.32 By establishing a 10 percent requirement (or setting a figure of $100 million for total EHS funding), the United States could greatly accelerate the growth in EHS research spending. In testimony before Congress in 2007, PCAST co-chair Floyd Kvamme warned against such a rapid increase: In general, increasing funding too rapidly does not lead to equivalent increases in high quality research. It is crucial to note that EHS research also depends on advances in non-EHS areas, such as instrumentation development and basic research on nanomaterials.33 Some non-governmental organizations (NGOs) have advocated for a more restrained approach to nanotechnology research and development. They assert that the federal government is pushing ahead too quickly in developing nanotechnology and encouraging its commercialization and use without sufficient knowledge and understanding of EHS implications and how they might be mitigated.34 They argue that the very characteristics that make nanotechnology promising also present significant potential risks to human health and safety and the environment. Some of 31 Denison, Richard A. "A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at least $100 Million Annually," Environmental Defense, April 2005. [http://www.edf.org/documents/4442_100milquestionl.pdf] 32 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. pp. 7, 27. 33 Kvamme, Floyd, co-chair, President's Council of Advisors on Science and Technology. Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative," 110th Cong., 1st Sess., October 31, 2007. 34 Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies, a joint venture of the congressionally-chartered Woodrow Wilson Center for International Scholars and the Pew Charitable Trusts. Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative," 110th Cong., 1st Sess., October 31, 2007. CRS-16 these groups argue for application of the "precautionary principle,"35 which holds that regulatory action may be required to control potentially hazardous substances even before a causal link has been established by scientific evidence.36 In 2006, Friends of the Earth warned that The early warning signs surrounding nanotoxicity are serious and warrant a precautionary approach to the commercialization of all products containing nanomaterials.... there should be a moratorium on the further commercial release of sunscreens, cosmetics and personal care products that contain engineered nanomaterials, and the withdrawal of such products currently on the market, until adequate public, peer-reviewed safety studies have been completed, and adequate regulations have been put in place...37 The Action Group on Erosion, Technology, and Concentration (ETC Group) has called for a moratorium on the conduct of nanotechnology R&D and use of commercial products incorporating man-made nanoparticles: Given the concerns raised over nanoparticle contamination in living organisms, Heads of State ... should declare an immediate moratorium on commercial production of new nanomaterials and launch a transparent global process for evaluating the socio-economic, health and environmental implications of the technology.38 In 2003, the ETC Group expanded the breadth of its proposed moratorium: In the absence of toxicology studies, ETC Group believes that governments must also urgently consider extending the moratorium to products that place consumers in direct contact with synthetic nanoparticles through their skin, lungs or digestive systems.39 35 The precautionary principle has been used in other countries on some issues and is the official policy in the European Union. For international agreements a precautionary approach is sometimes embraced. For example, the Biosafety Protocol to the 1992 Convention on Biological Diversity incorporates provisions applying the precautionary principle to the safe handling, transfer, and trade of genetically modified organisms. For further information, see CRS Report RL30594, Biosafety Protocol for Genetically Modified Organisms: Overview, by Alejandro E. Segarra and Susan R. Fletcher. 36 "NGOs urge precautionary principle in use of nanomaterials," EurActiv.com, June 14, 2007, [http://www.euractiv.com/en/environment/ngos-urge-precautionary-principle-use- nanomaterials/article-164619]; Sass, Jennifer, "Nanotechnology and the Precautionary Principle," presentation, Natural Resources Defense Council, 2006. [http://docs.nrdc.org/health/hea_06121401A.pdf] 37 Nanomaterials, Sunscreens, and Cosmetics: Small Ingredients, Big Risks, Friends of the Earth, May 2006. [http://www.foe.org/camps/comm/nanotech/nanocosmetics.pdf] 38 "No Small Matter," Communique, ETC Group, May/June 2002. [http://www.etcgroup.org/upload/publication/pdf_file/192] The ETC group is a non- governmental organization focused on the global societal impacts of emerging technologies. 39 "No Small Matter II: The Case for a Global Moratorium," Occasional Paper Series, ETC Group, April 2003. [http://www.etcgroup.org/upload/publication/pdf_file/165] CRS-17 In contrast to these views, a report prepared by the NSET Subcommittee concluded that conducting EHS research in parallel with the development of nanomaterials and their applications will help to ensure the full, safe, and responsible realization of the promise of nanotechnology.40 In 2003, then-Under Secretary of Commerce for Technology Phillip J. Bond addressed calls for a moratorium or slowdown in nanotechnology R&D, casting the issue in ethical terms: Those who would have us stop in our tracks argue that it is the only ethical choice. I disagree. In fact, I believe a halt, or even a slowdown, would be the most unethical of choices.... Given the promise of nanotechnology, how can our attempt to harness its power at the earliest opportunity -- to alleviate so many of our earthly ills -- be anything other than ethical? Conversely, how can a choice not to attempt to harness its power be anything other than unethical?41 Management of Federal EHS Research. In order to manage the Federal EHS portfolio, policymakers will need to establish research priorities. In this regard, the NRC recommended that Assessing the effects of engineered nanomaterials on public health and the environment requires that the research conducted be well defined and reproducible and that effective methods be developed and applied to (1) estimate the exposure of humans, wildlife, and other ecological receptors to source material; (2) assess effects on human health and ecosystems of both occupational and environmental exposure; and (3) characterize, assess, and manage the risks associated with exposure.42 In 2005, PCAST concluded that EHS research should give highest priority to workplace exposure. PCAST noted the greatest likelihood of exposure to nanomaterials is during manufacture, and therefore [we] agree with the prioritization of research on potential hazards from workplace exposure.43 Several years later, in its 2008 assessment, PCAST reiterated this point stating, "the greatest risk of exposure to nanomaterials at present is to workers who manufacture or handle such material," but also acknowledged a broader range of risks: 40 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, September 2006. p. vii. 41 Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. "Nanotechnology: Economic Opportunities, Societal and Ethical Challenges," keynote address, NanoCommerce 2003, December 9, 2003. 42 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p. 92. 43 The National Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, May 2005. p. 35. CRS-18 environmental, health, and safety risks in a wide range of NNI EHS-focused Reports settings must be identified and the necessary research Environmental Health and Safety performed so that real risks can Research Needs for Engineered Nanoscale be appropriately addressed.44 Materials, published in September 2006, identified the research and information Some stakeholders have asserted needed to enable sound risk assessment that a comprehensive approach to and risk management decision making federal EHS research has been with respect to nanoscale materials and hampered by the lack of an NNI products that incorporate them. roadmap for these efforts.45 In general, Prioritization of Environmental, these stakeholders seek a multi-year Health, and Safety Research Needs for roadmap with specific milestones, Engineered Nanoscale Materials, metrics, and funding levels. Such a published in August 2007, identified five roadmap, they assert, would contribute broad categories of EHS research and to a more coordinated approach among information needs, and five specific agencies and between the executive research areas in each category. branch and Congress on the magnitude, The National Nanotechnology timing, prioritization, and management Initiative: Strategy for Nanotechnology- of federal EHS research. related Environmental, Health, and Safety Research, published in February 2008, NNI officials argue that the NSET defined the NNI's strategy for addressing Subcommittee, the coordinating body priority research on EHS aspects of for the NNI, has developed an EHS nanomaterials. The document reviewed research strategy and articulated it in current agency research using the three reports (see text box, "NNI EHS- taxonomy developed in the second report; identified research gaps; and articulated a focused Reports"), though they framework for prioritizing research, acknowledge that these documents do implementing the strategy, and not constitute a roadmap. At an coordinating agency efforts. October 2007 hearing of the House Subcommittee on Research and Education,46 some Members of Congress expressed concerns about the time required by the National Nanotechnology Coordination Office to produce a prioritized, detailed implementation plan for NNI EHS research. While acknowledging the challenges faced by the NNCO in developing consensus among the 25 NNI agencies, some Members suggested that these challenges were emblematic of the need for a more top-down approach to EHS research. 44 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. p. 2. 45 Rejeski, David, director, Project on Emerging Nanotechnologies. Public comments on the Nanoscale Science, Engineering, and Technology Subcommittee's report, Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, September 12, 2007. [http://www.nanotechproject.org/process/files/5891/nehi_comments_070912_final.pdf] 46 Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative." 110th Cong., 1st Sess., October 31, 2007. CRS-19 Opposition to an EHS roadmap stems primarily from doubts of the practicality and efficacy of such an approach. Some argue that it is unlikely that OMB would commit to a multi-year, multi-agency roadmap accompanied by specific funding levels. Such an approach would depart from the current executive branch annual budget development process and reduce OMB's flexibility in future years. In addition, agencies often have to respond to new requirements based on emergent circumstances, Congressional direction, or other factors. Agency funding is often redirected from planned efforts to new, often imminent, priorities. The need for such redirection of funding could impede the achievement of roadmap milestones and metrics or, conversely, impede the movement of funding to new priorities. To overcome the obstacles associated with the development of a roadmap by the agencies, some have suggested the National Academies produce such a roadmap. Some assert that this approach worked well with respect to the development of a federal research roadmap to reduce EHS uncertainties associated with airborne particulate matter. Others argue that the particulate matter effort focused only a narrow field and covered research conducted by only a single agency (EPA); in contrast, nanotechnology spans a broad range of materials and applications across many fields, and requires EHS research efforts by several agencies. In February 2007, 19 environmental and business organizations, large and small companies, and research organizations signed a letter to the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies requesting $1 million be appropriated for the development of a federal roadmap and research strategy. The letter recommended that this work be done by the National Institute of Environmental Health Sciences (NIEHS).47 The Senate Appropriations Committee report (S.Rept. 110-91) accompanying the Department of the Interior, Environment, and Related Agencies Appropriations Act, 200848 urged the Environmental Protection Agency (EPA) to contract or enter into a cooperative agreement with the National Academy of Sciences' Board on Environmental Studies and Toxicology within 90 days of enactment to develop and monitor implementation of a comprehensive, prioritized research roadmap for all Federal agencies on environmental, health and safety issues for nanotechnology.49 47 An electronic copy of this letter, dated February 22, 2007, was provided to the Congressional Research Service (CRS) by the American Chemistry Council. 48 Incorporated as division F of the Consolidated Appropriations Act, 2008 (P.L. 110-161). 49 S.Rept. 110-91, p. 54. CRS-20 A Cooperative Approach to Addressing EHS Concerns Some organizations have taken a cooperative approach to promote EHS research. For example, the Environmental Defense Fund, an environmental advocacy group, partnered with the American Chemistry Council, a trade group, to issue a Joint Statement of Principles in June 2005 that recognizes the "significant societal and sustainable development benefits" expected from nanotechnology, while calling for a multi-stakeholder dialogue to achieve the timely development of nanomaterials "in a way that minimizes potential risks to human health and the environment." The statement also called for increased federal investments in EHS research and development of an international effort to standardize testing protocols, hazard and exposure assessment approaches, and nomenclature and terminology ... to maximize resources and minimize inconsistent regulation of nanomaterials.a There is general agreement among stakeholders that these activities can contribute to creating an environment where research results can be reliably shared and compared, to protecting human health and safety, and to creating a common language about nanotechnology that increases clarity in the sharing of ideas and information. However international standardization efforts are often time- and resource-consuming, and can divert resources from more pressing needs. In addition, such efforts can be used by nations and other organizations for competitive advantage (e.g., by securing the adoption of a favorable standard, slowing others' progress). In June 2007, the Environmental Defense Fund and DuPont issued a Nano Risk Framework "to assist with the responsible development and use of nanotechnology and to help inform global dialogue on its potential risks."b The framework is a six-step process to identify, address, and manage potential risks: (1) describe the material and the intended application; (2) profile the material's lifecycle in the application; (3) evaluate associated risks; (4) assess risk management options; (5) decide on and document actions; and, (6) regularly review new information and adapt actions accordingly.c a. Environmental Defense and American Chemistry Council Nanotechnology Panel: Joint Statement of Principles, Comments on EPA's Notice of a Public Meeting on Nanoscale Materials, June 23, 2005. b. "DuPont and Environmental Defense Launch Comprehensive Tool for Evaluating and Addressing Potential Risks of Nanoscale Materials," press release, E. I. du Pont de Nemours and Company, June 21, 2007. [http://vocuspr.vocus.com/VocusPR30/Newsroom/Query.aspx?SiteName= DupontNew&Entity=PRAsset&SF_PRAsset_PRAssetID_EQ=106677&XSL=PressRelease&Cache=False] c. Nanorisk Framework, Environmental Defense-DuPont Nano Partnership, June 2007. The process used to develop research priorities and the federal EHS budget has also raised management concerns. As discussed earlier, the federal nanotechnology EHS research portfolio results from research funding requests made by individual agencies pursuing their missions and by decisions made in the Congressional appropriations process. Informal research coordination among EHS funding agencies occurs through the NEHI working group and more formally through the OMB budget development process. Some proponents for an integrated federal EHS research effort have called for a more top-down approach. The Woodrow Wilson Center's Project on Emerging Nanotechnologies (PEN) has been a leading advocate on this issue. PEN's chief science advisor, Andrew Maynard, asserted that CRS-21 to realize nanotechnology's benefits ... the federal government needs a master plan for identifying and reducing potential risks. This plan should include a top-down risk research strategy, dedicated and sufficient funding to do the job, and the mechanisms to ensure that resources are used effectively.50 PEN has recommended increasing the authorities of the NEHI working group to empower it to develop and implement the top-down research plan, a minimum of $100 million over two years to fund the research, and a full-time director to support the NEHI working group. Responding to the PEN recommendation, E. Clayton Teague, director of the NNCO, testified before Congress that there was a consensus among NNI agencies that a centralized office with budgetary authority to oversee the NNI's EHS research program would have significant detrimental effects. According to Dr. Teague, No one agency or centralized organization would have the breadth of scientific expertise and knowledge of regulatory authorities and needs currently represented by the 20 agencies participating in the NEHI working group. Creation of a new central authority would undermine the existing successful interagency coordination. Moving the management of all nanotechnology EHS research into a single office would likely decouple such research from related efforts within NNI agencies and from the knowledge base in the agencies that is currently networked into the NNI's EHS research effort. Creating a separate office would, on the one hand, give mission agencies a disincentive for doing nanotechnology-related EHS research. They would reasonably assume that another agency is responsible, and they therefore could redirect their limited resources to address other priorities. A likely result could be that the level of research would actually decrease. Conversely, creating a separate office could lead to duplicative work being funded, thereby wasting tax dollars and not optimizing progress.51 50 Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies. "Public Meeting on Research Needs and Priorities Related to Environmental, Health, and Safety Aspects of Engineered Nanoscale Materials," comments, January 4, 2007. [http://www.nano.gov/html/meetings/ehs/uploads/20070103_1505_Nanotechnology_Ma ynard_NNCO_Comments.pdf] 51 Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on "Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation under the National Nanotechnology Initiative." 110th Cong., 1st Sess., October 31, 2007. CRS-22 Project on Emerging Nanotechnologies Recommendations The Project on Emerging Nanotechnologies (PEN), a joint venture of the congressionally-chartered Woodrow Wilson Center for International Scholars and the Pew Charitable Trusts, has produced inventories of both nanotechnology-based products and government-funded EHS research. PEN has asserted the need for more EHS research, more aggressive oversight, and a more centralized federal government approach to funding EHS research. In addition, PEN contends that the increasing complexity of systems incorporating nanoparticles with multiple functions will make the behaviors more complex and difficult to predict. To minimize the likelihood of a nanotechnology accident, PEN made the following recommendations: ! Creating a Nano Safety Reporting System where people working with nanotechnology can anonymously report safety issues and concerns. PEN states that the information gleaned from this system could be used to inform the design of educational materials, better structure technical assistance programs, and provide an early indicator of emerging safety issues. ! Creating technologies that provide an early-warning system to allow for risk to be assessed early in research efforts. Such a technology might enable low-cost, fast-screening for novel properties that would allow for risk assessment integrated and concurrent with the R&D process. ! Pushing information out to small businesses, start-ups, and laboratories that, due to their size and resources, are unlikely to be able to devote significant resources to EHS issues. PEN states that existing assistance programs could be used to deliver this information, as well as the development of peer-to-peer mentoring programs within industrial supply chains. ! Application of lessons learned in other technology areas to make nanotechnology more inherently safe, using strategies such as multiple levels of protection, learning from failures, not oversimplifying the complex, awareness of operations, and building in resilience to prevent cascading of errors. Source: Rejeski, David, director, Project on Emerging Nanotechnologies. "Nanotech Safety 101 or How to Avoid the Next Little Accident," paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006. Dr. Maynard counters that "it should be possible to develop a functional structure that enables agencies to work within a broader plan." According to Maynard, while a centralized office is not necessary, top-down leadership with authority and the ability to ensure resources get to where they are needed is necessary.... [Such] leadership does not take away from agencies' expertise and missions, but rather empowers agencies to do the best CRS-23 they can, while coordinating and partnering as effectively as possible with each other.52 Federal Regulation Some have raised concerns about whether current laws, regulations, and authorities are adequate to protect human health, safety, and the environment from potential adverse implications of nanotechnology. Several factors may affect the ability of the regulatory system to keep pace with advances in technology, both broadly and specifically with respect to nanotechnology. Broadly, market forces have increased the pace of global innovation, challenging institutions' ability to identify and cope with the societal implications of rapid change. Speed-to-market has become a driving factor in competition for Unique Properties Emerge many industries as a result of the entry at the Nanoscale of new and nimble competitors in the global marketplace, increased public Scientists have discovered that elements and private investments in R&D, and materials with the same chemistry can global models of innovation, increased exhibit fundamentally different properties at the nanoscale. For example, platinum, flows of scientific and technical which exhibits no magnetism in its bulk knowledge, and greater numbers of form, shows significant magnetic scientists and engineers around the properties in nanoscale clusters of 13 world. In addition, growing global atoms. The optical properties of gold also markets enable companies to recoup can change with particle size. At 10 their investments faster and enable nanometers, gold particles absorb green earlier investments in subsequent light and appear red, not gold. generations of technology, further accelerating the pace of innovation. Not only can nanoscale particles differ The increased pace, scope, and in properties from bulk material with the same chemical composition, they may also complexity of technological innovation differ from other nanoscale materials with may pose challenges to the existing the same chemical composition. For regulatory system. While these factors example, the melting point of an element may affect a broad range of -- which was believed to be constant technologies, nanotechnology may be regardless of the element's particle size -- especially affected due to the rapid can change with particle size. growth in public and private R&D Nanotechnology research has demonstrated investments in the field since the year that the melting temperature of gold 2000 and the potential for decreases when the particle's radius drops nanomaterials to be used in a wide below 10 nanometers (from a melting temperature of approximately 1,000oC at array of products. o 10 nanometers to approximately 500 C at 2 nanometers). Nanotechnology also may pose unique challenges to the regulatory Source: Roduner, Emil. "Nanoscopic system. For example, historically, Materials: Size-Dependent Phenomena," regulatory agencies have defined a University of Stuttgart, Germany, August 2006. 52 E-mail communication, November 21, 2007. CRS-24 chemical by its chemical composition, usually without regard to its particle size. In contrast, the essence of nanotechnology is that a material may exhibit different properties at the nanoscale than it does at a bulk, molecular, or atomic scale. (See text box, "Unique Properties Emerge at the Nanoscale.") Accordingly, questions are being raised by representatives of the scientific, advocacy, and regulatory communities about how an EHS research portfolio might be structured when particle size may affect a material's properties, whether it may be necessary to incorporate particle size into regulatory regimes, and how this might be accomplished given the vast spectrum of particle sizes that might affect the characteristics of a particular material. Some argue that EHS concerns about nanotechnology products can be handled under existing laws and regulations, while others see legal obstacles to adequate EHS regulation. In both of its assessments of the NNI, PCAST concluded that existing regulatory authorities were adequate for the current activities; that appropriate regulatory mechanisms should be used to address instances of harmful human or environmental effects of nanotechnology; and that new regulatory policies related to nanotechnology should be rational, science-based, and consistent across the federal government. Similarly, Sean Murdock, executive director of the NanoBusiness Alliance, asserted that The apparatus for effective nanotechnology regulation is largely in place through various statutes and agencies, but it lacks data and resources. To enable these agencies and for the nanotech regulation effort to succeed we must increase the level of funding available to them for nanotech environmental, health and safety research; coordinate efforts between agencies; establish metrics and standards that can be used to characterize nanomaterials; conduct ongoing research; and more.53 Others believe that new laws and regulations, or modifications to existing ones, may be required. J. Clarence Davies, senior advisor to the Project on Emerging Nanotechnologies and former EPA Assistant Administrator for Policy, Planning, and Evaluation argued that Nanotechnology is difficult to address using existing regulations. There are a number of existing laws -- notably the Toxic Substances Control Act; the Occupational Safety and Health Act; the Food, Drug and Cosmetic Act; and the major environmental laws (Clean Air Act, Clean Water Act, and Resource Conservation and Recovery Act) -- that provide some legal basis for reviewing and regulating [nanotechnology] materials. However, all of these laws either suffer from major shortcomings of legal authority, or from a gross lack of resources, or both. They provide a very weak basis for identifying and protecting the public from potential risk, especially as nanotechnologies become more complex in structure and function and the applications become more diverse. 53 "Nanotechnology Leaders to Converge in Washington, D.C., This Week for NanoBusiness Alliance Public Policy Tour," article, nanotechwire.com, February 16, 2006. [http://nanotechwire.com/news.asp?nid=2929] CRS-25 A new law may be required to manage potential risks of nanotechnology. The law would require manufacturers to submit a sustainability plan which would show that the product will not present an unacceptable risk.54 Davies further asserts that new mechanisms and institutional capabilities -- including research programs, tax breaks, acquisition programs, and regulatory incentives -- are needed to encourage beneficial applications of nanotechnology. In developing the regulatory structure, some in the business and financial communities assert that stability and predictability are key characteristics for attracting investment and spurring commercial applications. According to Matthew Nordan, vice president of Lux Research, the ambiguity surrounding environmental, health, and safety regulation of nanoparticles is hampering commercialization. Firms do not want to play a game whose rules may change at any time.... That doesn't mean they want more regulations or more onerous regulations. They're just looking for a roadmap on how federal agencies such as the EPA or OSHA [Occupational Safety and Health Administration] plan to approach nanoparticles.55 Some tension exists between the goals of promoting the development of nanotechnology, ensuring the global competitive position of the United States, addressing potential EHS implications of nanotechnology, and coping with the unique challenges nanotechnology poses to the current regulatory regime. To prevent health and safety concerns from becoming an impediment to innovation, some suggest that health and safety research and regulation must be done near-concurrently with product development, keeping pace with the speed of innovation. Alternatively, others argue that the potential health, safety, and environmental implications are either unknown or of such significance that EHS research and regulation must precede nanotechnology development and commercialization. "By the time monitoring catches up to commerce the damage will already have been done," asserted Ian Illuminato, health and environment campaigner for Friends of the Earth.56 AFL-CIO industrial hygienist Bill Kojola warned that Even though potential health hazards stemming from exposure have been clearly identified, there are no mandatory workplace measures that require exposures to be assessed, workers to be trained, or control measures to be implemented. [Nanotechnology] should not be rushed to market until these failings are corrected and workers assured of their safety.57 54 Davies, J. Clarence. Managing the Effects of Nanotechnology, Project on Emerging Nanotechnologies, January 2006. p. 3. [http://www.nanotechproject.org/process/assets/files/ 2708/30_pen2_mngeffects.pdf] 55 "U.S. Risks Losing Nano Lead," article, physorg.com, July 6, 2005. [http://www.physorg.com/news4963.html] 56 "International Coalition Calls for Oversight of Nanotechnology," press release, Friends of the Earth, July 31, 2007. [http://action.foe.org/dia/organizationsORG/foe/ pressRelease.jsp?press_release_KEY=248] 57 Ibid. CRS-26 The National Research Council assessment of the NNI acknowledged the need for additional reproducible, well-characterized EHS data to inform risk-based guidelines and best practices and warned that until such information is available precautionary measures should be taken to protect the health and safety of workers, the public, and the environment.58 In its 2008 assessment of the NNI, PCAST asserted that risk research must not be considered in isolation, but rather in the context of the overall risks and benefits of a particular material or technology. This perspective is shared by many industry advocates who argue that regulatory decisions must balance the potential risks associated with a nanotechnology product against the benefits it delivers and the risk it displaces. Further, they maintain that nanotechnology products should not be held to a higher standard than non-nanotechnology products. PCAST also noted that manufacturers and sellers of nanotechnology products had responsibilities for ensuring workplace and product safety, and asserted that the NNI has a vital role in supporting federal regulatory agencies by providing them with EHS research results. A description of selected nanotechnology EHS activities of federal regulatory agencies is provided in Appendix A. International Engagement International engagement on EHS issues is believed by many to be important to the responsible development and successful commercialization of nanotechnology. NNI officials assert that the United States has played a central role in convening international efforts to address EHS concerns. In its 2008 assessment, PCAST encouraged the NNI to coordinate its efforts with other nations to avoid duplication and to leverage investments, characterizing such work as "non-competitive."59 Federal agencies have engaged internationally (e.g., with agencies of other nations, international organizations, standards organizations) across a wide range of nanotechnology-related areas, including standards, nomenclature, and EHS research. Appendix B provides an overview of selected international engagement efforts of NNI agencies related to environmental, health, and safety issues. Advocates for international engagement assert a variety of potential benefits. For example, transparency and/or harmonization of standards and regulations may contribute to assurance of global supply chains and market confidence in nanotechnology products. Increased globalization of production and markets means that companies and consumers around the world are increasingly part of a common network. Manufacturers of final products generally rely on inputs from multiple suppliers in their global supply chains. The reliability of a final product often depends on the reliability of inputs, such as materials or components. Transparent 58 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.11. 59 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel, President's Council of Advisors on Science and Technology, April 2008. p. 33. CRS-27 and common standards and regulations may help to ensure the integrity of supply chains and final products. While this is an issue for a variety of non-nanotechnology products (e.g., the recent discovery of lead-tainted toys and other products imported from China), nanotechnology may present a unique challenge in that at least some nanoscale particles can be incorporated into materials and products in ways that cannot be easily detected or detected at all. Thus, producers and the consumers they serve must rely, in large measure, on standards and regulatory systems to ensure that nanoscale materials are properly produced and represented throughout the supply chain. In the absence of such standards and regulatory systems, producers may not be able to rely on inputs or may incur additional costs for testing and verification; substandard inputs may be incorporated in final products making them underperform or unsafe, and possibly resulting in loss of market confidence and/or potential litigation; or nanotechnology materials may be incorporated without disclosure. Internationally agreed upon standards could also contribute to greater comparability of research results, improving understanding of EHS-related aspects of nanotechnology, and promoting regulations that help protect human health and the environment. Common standards and nomenclature also may contribute to more effective global collaboration in nanoscale science, engineering, and technology R&D, accelerating the realization of nanotechnology's economic and societal potential. Global engagement may help to establish a common environment for the development and production of nanotechnology products and to promote access to global markets. In the absence of such an environment, some nations may seek to attract investments in their markets by adopting lower environmental, health, and safety standards and regulations. Finally, while much remains unknown about the transport and fate of nanoscale materials released into the environment, it is possible that countries and populations other than those where research and production activities take place may be affected. Efforts to promote the adoption of best practices in nanotechnology research, production, use, disposal, and recycling may protect human health and the environment worldwide. International engagement on EHS research may pose problems, including the time, cost, difficulty, and alleged ineffectiveness of such collaborations. For example, while some advocates assert the need for swift action in advancing EHS research, international engagements often entail slow processes. Also, given the strong U.S. position in nanotechnology, broadly, and in nanotechnology EHS research, specifically, some may argue that other countries have little to contribute, that such efforts tax limited federal EHS financial and human resources, and that such diffusion of resources may slow overall EHS progress. Others might assert that international engagement efforts focused explicitly on nanotechnology are unnecessary given the wide variety of existing mechanisms and pathways for sharing academic research and environmental, health, and safety information across national borders. Some may oppose international engagement efforts because they lack faith in the goodwill of some participating parties due to the potentially strong national interests CRS-28 at stake (e.g., military applications, economic growth, job creation). In 2003, then- Under Secretary of Commerce for Technology Phillip J. Bond questioned whether global calls for a slowdown in nanotechnology R&D to address environmental, health, and safety concerns are intended to allow other nations to close the nanotechnology leadership gap with the United States: I wonder very often if there are really calls for a slow-down so that other governments and countries might catch up.60 Others assert that the research required to understand and address EHS implications may be closely linked to applications-related R&D to create nanotechnology materials, products, or processes. In such cases, companies and countries may be reluctant to reveal EHS concerns and efforts, to cooperate in EHS research, or to share results as such actions may reveal competitive strategies, provide information others might use to compete against them (e.g., insights into promising materials or manufacturing processes), or result in unwanted scrutiny by regulators. Concluding Observations Advocates and critics agree that potential environmental, health, and safety implications of nanotechnology must be addressed if the full economic and societal benefits of nanotechnology are to be achieved. There is also general agreement that the current body of knowledge of how nanoscale materials might affect humans and the environment is insufficient to assess, address, and manage the potential risks. While there is agreement on the need for more EHS research, there are differing views on the level of funding required, how it should be managed, and related issues. Congress is currently considering legislation, S. 3274 and H.R. 5940, that would reauthorize and amend the 21st Century Nanotechnology Research and Development Act, the appropriations bills that fund the NNI agencies' nanotechnology EHS research, and two other bills (H.R. 3235, H.R. 4040) with nanotechnology EHS provisions. Congress may use these opportunities to further address nanotechnology EHS implications issues, including: How much should the federal government appropriate for EHS research? How can the federal EHS research investment be better accounted for? How should the research be prioritized? Should the research be more centrally managed? How can EHS research results and best practices be shared more broadly? Can voluntary programs effectively provide needed information about industrial nanotechnology production activities? How can efforts to develop common nomenclature and standards be improved? Are existing laws, regulations, guidelines, and regulatory structures adequate? Is there sufficient coordination among federal regulatory agencies? What types of international engagement on nanotechnology research and regulatory issues could best foster responsible development of nanotechnology? 60 Regional, State, and Local Initiatives in Nanotechnology, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, 2005. p. 33. CRS-29 Nanotechnology EHS-Related Legislation in the 110th Congress Four bills introduced in the 110th Congress contain provisions that seek to address nanotechnology EHS concerns. The following section summarizes selected EHS- related provisions of these bills. H.R. 5940 -- National Nanotechnology Initiative Amendments Act of 2008 H.R. 5940, the National Nanotechnology Initiative Amendments Act of 2008, was introduced on May 1, 2008. This act would revise the 21st Century Nanotechnology Research and Development Act in a variety of ways, several of which specifically address nanotechnology EHS concerns. The legislation: ! directs the National Nanotechnology Coordination Office to develop and maintain a public database of NNI EHS projects, including the agency funding source and funding history; ! requires the National Nanotechnology Advisory Panel (NNAP) to be established as a "distinct entity" (the NNAP's functions are currently performed by the President's Council of Advisors on Science and Technology), and requires the establishment of a subpanel to assess whether societal, ethical, legal, environmental, and workforce concerns are adequately addressed by the NNI; ! directs that the National Research Council, as part of its triennial review of the NNI, evaluate the adequacy of the NNI's efforts to address ethical, legal, environmental, human health, and other appropriate societal concerns; ! requires the designation of an associate director of the White House Office of Science and Technology Policy to serve as Coordinator for Societal Dimensions of Nanotechnology with responsibility for developing an annual research plan for federal nanotechnology EHS activities, monitoring and encouraging agency EHS efforts, and for encouraging agencies to engage in public-private partnerships to support EHS research; ! requires certain interdisciplinary research centers supported under the NNI to include EHS research to develop methods for developing environmentally benign nanoscale products and processes, to foster the transfer of research results to industry, and to provide interdisciplinary study programs to educate scientists and engineers in these methods; ! directs NNI agencies to support the activities of standards setting bodies involved in the development of standards for nanotechnology, CRS-30 including authorizing agency reimbursement of travel costs of scientists and engineers participating in these activities; and ! requires activities supported under the NNI's Education and Societal Dimensions program component area to include environmental, health, and safety education in its informal, pre-college, and undergraduate nanotechnology education efforts. On June 5, 2008, the House of Representatives passed the bill by a vote of 407-6. The bill has been referred to the Senate Committee on Commerce, Science, and Transportation. S. 3274 -- National Nanotechnology Initiative Amendments Act of 2008 S. 3274, the National Nanotechnology Initiative Amendments Act of 2008, was introduced on July 16, 2008, and referred to the Senate Committee on Commerce, Science, and Transportation. The act would reauthorize and amend the 21st Century Nanotechnology Research and Development Act. The legislation includes a variety of provisions that address nanotechnology EHS issues. The legislation: ! expands the scope of the NNI by identifying as specific missions: (1) support for the development of standard reference materials, instrumentation, measurement science, and computational tools to measure, characterize, and predict the properties of nanoscale materials, and (2) participation in national and international efforts to develop regulatory guidelines, plans, and standards for the safe use of nanotechnology; ! requires, as part of the NNI's triennial strategic plan, a review of efforts to encourage joint interagency solicitations of grant applications for instrumentation and metrology equipment to detect, measure and characterize nanomaterials; ! directs NNI agencies to support the activities of standards setting bodies involved in the development of standards for nanotechnology, including authorizing agency reimbursement of travel costs of scientists and engineers participating in these activities; ! directs the National Nanotechnology Coordination Office to develop and maintain a public database of NNI EHS projects, including a project description, agency funding source, and funding history; ! requires the National Nanotechnology Advisory Panel (NNAP) to be established as a "distinct entity" (the NNAP's functions are currently performed by the President's Council of Advisors on Science and Technology), and requires the establishment of a subpanel on societal, ethical, legal, environmental, and workforce concerns; CRS-31 ! directs that the National Research Council, as part of its triennial review of the NNI, assess the adequacy of the NNI's activities to address ethical, legal, environmental, and human health concerns; ! requires the designation of an associate director of the White House Office of Science and Technology Policy to serve as Coordinator for Societal Dimensions of Nanotechnology with responsibility for: developing an annual research plan for federal nanotechnology EHS activities; providing oversight of the coordination, planning, and budget prioritization of the NNI's EHS activities; and encouraging agencies to engage in public-private partnerships to support EHS research; ! requires activities supported under the NNI's Education and Societal Dimensions program component area to include environmental, health, and safety education in its informal, pre-college, and undergraduate nanotechnology education efforts; ! directs the NNAP to periodically review the level of funding for the NNI's Environmental, Health, and Safety program component area; determine whether it is sufficient to address the research needs identified in the annual EHS research plan; and, recommend an appropriate level of funding to the Coordinator for Societal Dimensions of Nanotechnology if the current level is found to be insufficient or excessive; ! requires certain interdisciplinary research centers supported under the NNI to include EHS research to conduct research on methods for developing environmentally benign nanoscale products and processes, to foster the transfer of research results to industry, and to provide interdisciplinary study programs to educate scientists and engineers in these methods; ! requires certain interdisciplinary research centers supported under the NNI to include research on methods to develop characterization and metrology capabilities relevant to the NNI's Environmental, Health, and Safety program component area, and to foster the transfer of results to industry; ! directs the Government Accountability Office (GAO) to conduct, within two years, a study of federal codes, standards, and regulations as they pertain to the safe production, use, and disposal of engineered nanomaterials and products that incorporate them; to evaluate comparable international efforts; identify gaps in the ability of federal agencies to enforce cost-effective safety procedures using current codes, standards, and regulations; and develop recommendations for changes to such codes, standards, and regulations to remedy identified gaps; and CRS-32 ! authorizes $2 million for the NNCO to convene a national discussion, including at least two large-scale deliberative forums, to engage U.S. citizens, increase their awareness of nanotechnology, and seek to identify collective priorities and concerns; a report to Congress summarizing the national discussion is required one year from the date of enactment of the legislation. H.R. 3235 -- Nanotechnology Advancement and New Opportunities Act H.R. 3235, the Nanotechnology Advancement and New Opportunities Act, was introduced on July 31, 2007. Among its provisions, the bill would require the NNCO to produce an annual research strategy that establishes priorities for the development and responsible stewardship of nanotechnology, as well as providing recommendations regarding the funding required to implement the strategy. On July 31, 2007, H.R. 3235 was referred to the House Science and Technology Committee's Subcommittee on Research and Science Education; the House Ways and Means Committee; the House Energy and Commerce Committee's Subcommittee on Commerce, Trade, and Consumer Protection; and the House Homeland Security Committee's Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology. H.R. 4040 -- CPSC Reform Act H.R. 4040, the CPSC Reform Act, was introduced November 1, 2007. Among its provisions, the bill authorizes $1 million for the Consumer Product Safety Commission for fiscal years 2009 and 2010 for research, in cooperation with the National Institute of Standards and Technology, the Food and Drug Administration, and other relevant federal agencies, on safety issues related to the use of nanotechnology in consumer products. H.R. 4040 was passed by the House of Representatives on December 19, 2007, by a vote of 407-0, and subsequently passed by the Senate on March 6, 2008, by a vote of 79-13. The bill is in conference. For additional information, see CRS Report RL34399, Consumer Product Safety Improvement Act of 2008: H.R. 4040, by Margaret Mikyung Lee. CRS-33 Appendix A. Selected Nanotechnology EHS Activities of Federal Regulatory Agencies Several federal regulatory agencies have begun to grapple with the EHS issues raised by nanotechnology in their spheres of responsibility. Some critics argue that there is a potential conflict of interest among some regulatory agencies that are, on the one hand, conducting and promoting nanotechnology research and that are, on the other hand, responsible for regulating nanotechnology applications. The following section provides an overview of selected EHS-related nanotechnology activities of federal regulatory agencies. Environmental Protection Agency. The Environmental Protection Agency (EPA) co-chairs the NEHI working group of the NSET, along with the National Institute for Occupational Safety and Health (NIOSH), a research institute within the Department of Health and Human Services. EPA, which has both a research function and a regulatory function, has asserted a need for more information to assess the potential EHS impacts of most engineered nanoscale materials. According to EPA, this information is needed ... to establish a sound scientific basis for assessing and managing unreasonable risks that may result from the introduction of nanoscale materials into the environment.61 EPA is supporting research on the toxicology, fate, transport, transformation, bioavailability, and exposure of humans and other species to nanomaterials to obtain information for use in risk assessment, a central aspect of EPA's mission.62 EPA reports it is working collaboratively with stakeholders both domestically and internationally to address industrial chemical nanoscale materials. (International EHS collaboration is discussed in Appendix B.) One example of EPA's domestic work is its effort to establish a Nanoscale Materials Stewardship Program (NMSP). The purpose of the NMSP is to engage industry in a process that will foster effective federal government decision-making through the sharing of otherwise proprietary information about the characteristics, development, and manufacture of nanoscale materials. As envisioned by EPA, the program is designed primarily to engage manufacturers of nanoscale materials that would be considered existing chemical substances under the Toxic Substances Control Act (TSCA), but also encourages the participation of individuals and organizations working at a variety of stages of product development. EPA says that NMSP is intended to help provide a firmer scientific foundation for regulatory decisions by encouraging the development of key scientific information and appropriate risk management practices for nanoscale chemical substances. 61 "Fact Sheet for Nanotechnology under the Toxic Substances Control Act," Environmental Protection Agency. [http://www.epa.gov/oppt/nano/nano-facts.htm] 62 "Exploratory Research: Nanotechnology Research Grants Investigating Fate, Transport, Transformation, and Exposure of Engineered Nanomaterials: A Joint Research Solicitation - EPA, NSF, & DOE," Environmental Protection Agency. [http://es.epa.gov/ncer/rfa/2007/ 2007_star_nanotech.html] CRS-34 According to EPA, the data acquired through NMSP will be used to gain an understanding of which nanoscale materials are produced, in what quantities, how they are used, and the data that are available for such materials. EPA maintains that its scientists will use data collected through this program, where appropriate, to aid in determining how and whether certain nanoscale materials or categories of nanoscale materials may present risks to human health and the environment. EPA states that NMSP is also intended to assist in the identification and adoption of risk management practices in the development and commercialization of nanoscale materials, to encourage the development of test data needed to provide a firmer scientific foundation for future work and regulatory/policy decisions, and to promote responsible development.63 EPA solicited comments on the NMSP from stakeholders in a July 2007 Federal Register Notice.64 The business community has been supportive of the use of voluntary programs to address EHS risks of nanotechnology. The NanoBusiness Alliance states in its EHS research policy statement that "EPA and NIOSH should receive adequate funding to develop and implement their voluntary programs."65 Other organizations have expressed frustration with the speed at which EPA is moving to implement the NMSP. At an EPA public meeting held in August 2007, Richard Denison, senior scientist for the Environmental Defense Fund, testified that As a government response to addressing the possible downsides of the nanotechnology revolution, [the NMSP is] simply `too little, too late.'66 The Project on Emerging Nanotechnologies' J. Clarence Davies testified at the same meeting that while NMSP is ... potentially a useful initiative ... The delay in starting the NMSP is discouraging. It gives a signal that there really is no urgency, that the agency is in no hurry to start the voluntary program, much less institute an adequate regulatory system.67 Some observers say that past experience with other voluntary environmental programs shows that such efforts can produce benefits for both industry and government. For industry, voluntary programs may provide an opportunity to 63 EPA notes that the National Research Council described "responsible development" in its first triennial review of the NNI as "the balancing of efforts to maximize the technology's positive contributions and minimize its negative consequences. Thus, responsible development involves an examination both of applications and of potential implications. It implies a commitment to develop and use technology to help meet the most pressing human and societal needs, while making every reasonable effort to anticipate and mitigate adverse implications or unintended consequences." 64 "Nanoscale Program Approach for Comment," Environmental Protection Agency. [http://www.epa.gov/oppt/nano/nmspfr.htm] 65 "Nanotech Environmental, Health and Safety: Progress and Priorities," NanoBusiness Alliance. [http://www.nanobusiness.org/ehspolicy.php] 66 "EPA's Actions on Health Risks of Nanomaterials Called `Too Little, Too Late,'" press release, Environmental Defense Fund, August 2, 2007. 67 Davies, J. Clarence, testimony, EPA Public Meeting on Nanoscale Materials Stewardship Program, August 2, 2007. [http://www.nanotechproject.org/file_download/212] CRS-35 provide input into the regulatory process, to delay costly and constraining mandatory regulations, and to improve corporate goodwill. For government, voluntary programs may increase access to real-world data and information, may reduce the cost of data creation and/or collection, provide insights into new problems and about emerging industries, and provide a mechanism to control pollutants that are currently unregulated and for which jurisdiction may be hard to obtain.68 Others maintain that voluntary programs can be counterproductive if they delay implementation of an adequate oversight system. Multiple statutes govern EPA's authority to regulate nanotechnology materials and devices, including the Clean Air Act (CAA, 42 U.S.C. 7401 et seq); Clean Water Act (CWA, codified generally as 33 U.S.C. §§1251-1387); Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C.136-136y); and Toxic Substances Control Act (15 U.S.C. 2601 et seq.).69 Important issues have been raised about the application of EPA's authorities to regulate nanotechnology. Key issues revolve around TSCA, which authorizes regulation of chemical commerce.70 Under the provisions of TSCA, producers of a "new" material must provide EPA with a premanufacture notification (PMN). EPA then has 90 days to approve manufacture, to require information from manufacturers, or to restrict chemical use. Other TSCA provisions permit EPA regulation of existing chemicals already in commerce, but these rely on EPA fact-finding and rulemaking before EPA can require testing or restrict uses. Several NGOs have urged EPA to consider all nanoscale materials "new" regardless of whether the material is on the EPA inventory list in its bulk form.71 However, some nanotechnology materials have the same chemical composition as materials that are already in commerce, raising the question of whether the nanotechnology materials are "new" and thus subject to PMN requirements. With respect to this issue, EPA stated that EPA is considering how best to evaluate and, where appropriate, manage the risks associated with engineered nanoscale materials (NMs).... Nanoscale materials are "chemical substances" as defined under TSCA and are subject to the law unless otherwise excluded. Thus premanufacture notifications (PMNs) are required under TSCA prior to manufacturing a NM "new" chemical substance. To assist potential submitters, EPA is developing a general approach to the TSCA inventory status of nanoscale substances in making the distinction between "new" and "existing" 68 Berger, Michael. "Implementing successful voluntary nanotechnology environmental programs appears to be a challenge," Nanowerk LLC, November 29, 2007. [http://www.nanowerk.com/spotlight/spotid=3476.php] 69 For additional information, see CRS Report RL30798, Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency (EPA), coordinated by Susan R. Fletcher. 70 For more information about TSCA and nanotechnology, see CRS Report RL34118, The Toxic Substances Control Act (TSCA): Implementation and New Challenges, by Linda-Jo Schierow. 71 "The EPA's Toxic Substances Control Act: What you must know," Small Times, September/October 2007. CRS-36 chemicals that are nanoscale materials. EPA is also developing an umbrella approach for evaluating both new and existing chemicals in NMs.72 When nanomaterials are intended to control pests, including microbes, FIFRA may offer EPA more authority to regulate nanotechnology than TSCA, according to Lynn Bergeson, chair of the American Bar Association's Section on Environment, Energy, and Resources: Under TSCA, once a substance is on the approved inventory list, any use is legitimate, but FIFRA is use-specific. The EPA always has the authority to assess the risk of pesticides, regardless of the use.73 Applicability of FIFRA to nanotechnology products was one aspect of a November 2006 EPA ruling that a device that "incorporates a substance intended to prevent, destroy or mitigate pests" is considered a pesticide and is required to be registered under FIFRA. While the ruling is not unique to nanomaterials, it came in the context of advertising claims for a washing machine containing nanoscale silver ions that kill microbes. EPA's ruling made this appliance the first nanotechnology product to be regulated under FIFRA. However, claims for the pesticidal effectiveness of the washing machine have been removed from advertisements, possibly limiting EPA's ability to regulate the device as a pesticide under FIFRA. Food and Drug Administration. A variety of current and future products that incorporate nanotechnology fall, or may fall, under the regulatory auspices of the Food and Drug Administration (FDA), including cosmetics, medical devices, foods, drugs, biological products, and combination products.74 FDA anticipates that many of the nanotechnology products that the agency is likely to regulate will be combination products, such as drug-device, drug-biological, or device-biological products. According to FDA, it regulates products based on their statutory classification rather than the technology they employ, thus the agency may not provide regulatory consideration to a nanotechnology product until well after its initial development.75 Also, some critics maintain that FDA's limited regulatory authority over certain categories of products may limit its authority to regulate nanotechnology products. With respect to the need for unique tests or requirements for regulating nanotechnology products, FDA states that its existing requirements may be adequate for most nanotechnology products it expects to regulate. FDA has asserted that nanotechnology products are in the same size-range as the cells and molecules its reviewers and scientists deal with every day. The agency says that every degradable 72 "New Nanotechnology Products," Environmental Protection Agency. [http://www.epa.gov/oppt/ar/20052006/managing/new_nano.htm] 73 "EPA Regulates Nano Product, Not Nano Industry," Small Times, January 2007. 74 For additional information, see CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007, by Judith A. Johnson, Donna V. Porter, Susan Thaul, and Erin D. Williams. 75 "FDA and Nanotechnology Products," Food and Drug Administration. [http://www.fda.gov/nanotechnology/faqs.html] CRS-37 medical device and injectable pharmaceutical generates particulates that pass through the nanoscale size range during the processes of their absorption and elimination by the body. According to FDA, it has no knowledge of reports of adverse reactions related to the "nano" size of resorbable drug or medical device products. New tests or other requirements may be needed, according to FDA, if new risks are identified arising from new materials or manufacturing techniques. FDA has established a Nanotechnology Interest Group (NTIG) comprised of representatives from each of its centers to facilitate the regulation of nanotechnology products.76 Others, in particular consumer groups, counter that FDA's resources are insufficient to adequately address the safety of emerging technologies in general, and that the agency's regulatory approach, particularly for cosmetics, dietary supplements, and other products for which pre-market review is not required, would not detect any problems until such products had been in use.77 FDA does not provide grants for nanotechnology research but does conduct research in several of its centers to understand the characteristics of nanomaterials and nanotechnology processes. FDA is also collaborating with NIEHS on studies, as part of the interagency National Toxicology Program (NTP), examining the skin absorption and phototoxicity of nano-sized titanium dioxide and zinc oxide preparations used in sunscreens. FDA says that there currently is no international regulation of nanoproducts or the underlying nanotechnology. FDA participates in multinational organizations where cooperative work on nanotechnology has been proposed, including the Organization for Economic Cooperation and Development (OECD), ASTM International, and the International Organization for Standardization (ISO). FDA plans to work with its foreign regulatory counterparts to share perspectives and information on regulation of nanotechnology.78 National Institute of Environmental Health Sciences/National Toxicology Program. While not a regulatory agency, NIEHS is conducting nanotechnology EHS research that will support the missions of regulatory agencies. In particular, NIEHS serves as home to the interagency National Toxicology Program. The NTP's mission is to coordinate toxicological testing programs, develop and validate improved testing methods, develop approaches and generate 76 Ibid. 77 See, for example, Michael Taylor, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? The Project on Emerging Nanotechnologies, October 2006, at [http://www.nanotechproject.org/news/archive/is_fda_nanotech-ready]. The FDA Science Board, Subcommittee on Science and Technology, designated nanotechnology as one of eight emerging technologies that are most challenging for FDA. See FDA Science Board, Subcommittee on Science and Technology, FDA Science and Mission at Risk, November 2007, p. 4, at [http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA Report on Science and Technology.pdf]. The FDA Science Board is the advisory board to the FDA Commissioner. 78 FDA and Nanotechnology Products: Frequently Asked Questions, Food and Drug Administration, U.S. Department of Health and Human Services. [http://www.fda.gov/ nanotechnology/faqs.html] CRS-38 data to strengthen scientific knowledge about potentially hazardous substances, and communicate with stakeholders.79 In 2006, the NTP established the Nanotechnology Safety Initiative (NSI), a broad-based research program to address potential human health hazards associated with the manufacture and use of nanoscale materials. The goal of this research program is to evaluate the toxicological properties of major nanoscale materials that represent a cross-section of composition, size, surface coatings, and physical and chemical properties, and to use these as model systems to investigate fundamental questions concerning whether nanoscale materials can interact with biological systems and how they might do so.80 According to NTP, the NSI is focused on three areas of research with respect to specific types or groups of nanoscale materials: ! non-medical, commercially relevant and available nanoscale materials to which humans are intentionally being exposed, such as cosmetics and sunscreens; ! nanoscale materials representing specific classes (e.g., fullerenes and metal oxides) so that information can be extrapolated to other members of those classes; and ! subsets of nanomaterials to test specific hypotheses about a key characteristic (such as size, composition, shape, or surface chemistry) that might be related to biological activity. Current NSI research activities are focused on metal oxides, fluorescent crystalline semiconductors (also known as quantum dots), fullerenes, and carbon nanotubes. NTP has also established a Nanotechnology Working Group (NWG) to serve as a technical advisory body to provide a structured and formal mechanism for bringing stakeholders together to learn about NTP nanotechnology research related to public health, address issues related to that research, and promote dissemination of those discussions to other federal agencies, nanotechnology stakeholders, and the public. Another function of the NWG is to provide a mechanism for the public and interested parties to provide advice to the NTP Board of Scientific Counselors. Occupational Safety and Health Administration/National Institute for Occupational Safety and Health. The mission of the Occupational Safety and Health Administration (OSHA), an agency of the Department of Labor, is to ensure the safety and health of America's workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace safety and health. OSHA has not yet taken any regulatory actions with respect to nanotechnology. 79 "Toxicology in the 21st Century: The Role of the National Toxicology Program," Update, National Toxicology Program, January 2004. [http://ntp.niehs.nih.gov/ntp/htdocs/Liaison/ 2004JanLO_News.pdf] 80 Toxicology in the 21st Century: The Role of the National Toxicology Program, Department of Health and Human Services, February 2004. [http://ntp.niehs.nih.gov/ntp/ main_pages/NTPVision.pdf] CRS-39 The National Institute for Occupational Safety and Health (NIOSH), a part of the Department of Health and Human Services, is the lead federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. NIOSH co-chairs the NSET's NEHI working group. NIOSH is not a regulatory agency, but its work directly supports OSHA and other regulatory agencies. NIOSH states that its nanotechnology efforts are building on its experience in defining the characteristics, properties, and effects of ultrafine particles -- such as welding fumes and diesel particulates -- as well as its experience in conducting advanced health effects laboratory studies and in fostering industrial hygiene policies and practices. NIOSH has developed interim guidelines for working with nanomaterials. The agency asserts that these guidelines are consistent with the best scientific knowledge of nanoparticle toxicity and control. NIOSH also maintains a Nanoparticle Information Library with information on the health and associated properties of nanomaterials as an online resource for occupational health professionals, industrial users, worker groups, and researchers.81 NIOSH and OSHA are considering risk management approaches that do not rely on traditional exposure- and time-limits. These new approaches seek to maximize flexibility for innovation while ensuring the health and safety of workers.82 Consumer Product Safety Commission. The Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of serious injury or death from certain types of consumer products.83 CPSC asserts that potential safety and health risks of nanomaterials can be assessed under existing CPSC statutes, regulations and guidelines. Since the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) do not require pre-market registration or approval of products, CPSC does not evaluate a product's risk to the public until it has been distributed in commerce. In August 2005, CPSC commissioners approved a nanotechnology statement which notes that nanotechnology presents challenges that "may require unique exposure and risk assessment strategies." The CPSC statement identified regulatory challenges, including identification of the specific nanomaterial in a product; the need to characterize the materials to which a consumer is exposed during product use, including an assessment of the size distribution of the materials released; and the 81 "Nanotechnology at NIOSH," National Institute for Occupational Safety and Health. [http://www.cdc.gov/niosh/topics/nanotech/] 82 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council, The White House, September 2006. 83 CPSC's regulatory authorities are provided by the Consumer Product Safety Act; Federal Hazardous Substances Act of 1960, as amended by the Toy Safety Acts of 1969 and 1984 and the Child Protection Amendments of 1966; Poison Prevention Packaging Act of 1970; Flammable Fabrics Act of 1953; and Refrigerator Safety Act of 1956. For additional information, see CRS Report RS22821, Consumer Product Safety Commission: Current Issues, by Bruce K. Mulock. CRS-40 application of toxicological data of appropriate particle sizes to assess health risks. However, the CPSC takes the position that it is unable to make any general statements about potential consumer exposure to nanomaterials or the health effects that may result from exposure to nanomaterials during consumer use and disposal due to the wide variation in potential health effects and the dearth of exposure and toxicity data for specific nanomaterials.84 84 "CPSC Nanomaterial Statement," Consumer Product Safety Commission, August 2005. [http://www.cpsc.gov/library/cpscnanostatement.pdf] CRS-41 Appendix B. Selected International Engagement Efforts of NNI Agencies Federal agencies have engaged internationally (e.g., with agencies of other nations, international organizations, standards organizations) on a host of nanotechnology-related issues, with a focus on EHS-related efforts such as scientific research, standards, nomenclature and terminology. The following section provides an overview of some of these activities. In June 2004, the U.S. government initiated and hosted the first International Dialogue on Responsible Research and Development of Nanotechnology in Alexandria, Virginia. The meeting was attended by representatives from 25 countries and the European Union. The following year the NSET Subcommittee established the Global Issues in Nanotechnology (GIN) working group. In addition to monitoring foreign nanotechnology programs and promoting U.S. commercial and trade interests in nanotechnology, GIN was chartered to broaden international collaboration on nanotechnology R&D, including research on safeguarding the environment and human health. GIN representatives participated in the second International Dialogue on Responsible Research and Development of Nanotechnology hosted by the European Community (EC) in Brussels in July 2005. These meetings focused on clarifying issues and concerns of scientists, engineers, and policymakers working in nanotechnology around the world. GIN representatives have also participated in nanotechnology-related activities of the Organization for Economic Cooperation and Development (OECD). In June 2005, chemical experts from 30 OECD countries participated in the Joint Meeting of Chemicals Committee and Working Party on Chemicals, Pesticides, and Biotechnology. Participants agreed to launch an international effort to coordinate assessment procedures for chemicals manufactured with nanotechnologies, to work toward linking national databases on high production-volume chemicals, and to establish a harmonized template for reporting hazard data needed for the notification and registration of new and existing chemicals, biocides, and pesticides. In December 2005, EPA hosted and chaired a second meeting of this group in Washington, D.C., on the safety of manufactured nanomaterials. In October 2005, the United States proposed the creation of a Working Party on Nanotechnology within the OECD's Committee for Scientific and Technological Policy. Established in March 2007, the objective of this working party is to promote international co-operation that facilitates research, development, and responsible commercialization of nanotechnology in member countries and in non-member economies.85 EPA is also participating in the OECD's Working Party on Manufactured Nanomaterials which was established in September 2006 to facilitate international collaboration on EHS issues related to manufactured nanomaterials.86 85 "OECD Work on Nanotechnology," Organization for Economic Cooperation and Development. [http://www.oecd.org/sti/nano] 86 "Fact Sheet for Nanotechnology Under the Toxic Substances Control Act," Environmental (continued...) CRS-42 Another focus of U.S. international cooperation efforts has been in the development of nanotechnology standards. In response to a request from the White House Office of Science and Technology Policy, the American National Standards Institute (ANSI) established the Nanotechnology Standards Panel (NSP) in June 2004 to facilitate and coordinate nanotechnology standards development in the United States, focusing its initial work on nomenclature and terminology.87 Subsequently, the International Organization for Standardization (ISO) established the Nanotechnologies Technical Committee, a parallel organization to ANSI's NSP. E. Clayton Teague, director of the NNI NNCO, chairs the ANSI-accredited Technical Advisory Group (TAG) to the ISO and leads the U.S. delegation. The United States was selected to lead the ISO Technical Committee's Working Group on Health, Safety, and Environmental Aspects of Nanotechnologies. The Working Group has forwarded the NIOSH document "Approaches to Safe Nanotechnology," incorporating additional input from five other countries, to the ISO Technical Committee on Nanotechnologies (ISO TC 229) for a full review. If approved by the ISO Technical Committee, the document (re-titled "Health and Safety Practices in Occupational Settings Relative to Nanotechnologies") will be issued as an international Publicly Available Specification, an informational document available to all countries. NSET reports that significant progress on nanotechnology terminology and nomenclature has also been made by the TC 229 working group. Federal government funding also contributed to the establishment of the International Council on Nanotechnology (ICON), a non-profit organization. ICON was established as an affiliate program of the NSF-funded, Rice University-based Center for Biological and Environmental Nanotechnology (CBEN), and has received funding from the National Science Foundation, the National Institutes of Health, and other private and non-profit organizations. ICON characterizes its purpose as seeking to catalyze global activities that lead to sound and responsible nanotechnology risk assessment, management, and communications. ICON has held EHS workshops, produced EHS reports, developed an online database of scientific findings related to the benefits and risks of nanotechnology, and designed and executed a survey of corporate nanotechnology EHS practices. In March 2007, ICON and CBEN jointly launched The Virtual Journal of Nanotechnology Environment, Health, and Safety, which contains citations and links to articles on the EHS impacts of nanotechnology. 86 (...continued) Protection Agency. [http://www.epa.gov/oppt/nano/nano-facts.htm]; "OECD Work on Nanotechnology," Organization for Economic Cooperation and Development. [http://www.oecd.org/sti/nano] 87 "ANSI Establishes Nanotechnology Standards Panel," American National Standards Institute, August 5, 2004. [http://www.ansi.org/news_publications/ news_story.aspx?menuid=7&articleid=735] ------------------------------------------------------------------------------ For other versions of this document, see http://wikileaks.org/wiki/CRS-RL34614