Strategic Plan

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Strategic Plan

  1. 1. Strategic Plan for NIOSH Nanotechnology Research and Guidance Filling the Knowledge Gaps DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health
  2. 2. On the cover: Scanning electron microscopy image of “spheres” of agglomerated nanometer sized to TiO2. Courtesy of Altairnano, Inc. Used with permission.
  3. 3. Strategic Plan for NIOSH Nanotechnology Research and Guidance Filling the Knowledge Gaps DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health
  4. 4. This document is in the public domain and may be freely copied or reprinted. Disclaimer Mention of any company or product does not constitute endorsement by the National In- stitute for Occupational Safety and Health (NIOSH). In addition, citations to Web sites external to NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs or products. Furthermore, NIOSH is not responsible for the content of these Web sites. All Web addresses referenced in this document were accessible as of the publication date. Ordering Information To receive documents or other information about occupational safety and health topics, contact NIOSH at Telephone: 1–800–CDC–INFO (1–800–232–4636) TTY: 1–888–232–6348 E-mail: cdcinfo@cdc.gov or visit the NIOSH Web site at www.cdc.gov/niosh. For a monthly update on news at NIOSH, subscribe to NIOSH eNews by visiting www.cdc.gov/niosh/eNews. DHHS (NIOSH) Publication No. 2010–105 November 2009 Safer • Healthier • People™ ii Strategic Plan for NIOSH Nanotechnology
  5. 5. Foreword The National Institute for Occupational Safety and Health (NIOSH) is pleased to present the Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps. This plan updates the September 2005 strategic plan using knowledge gained from results of ongoing research as described in the 2007 report Progress Toward Safe Nanotech- nology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The NIOSH nanotechnology research program is a cross-sector program that supports the National Oc- cupational Research Agenda (NORA). Nanotechnology provides many opportunities and challenges for all of us in occupational safety and health. The Strategic Plan for the nano- technology program is the roadmap we are using to advance knowledge about the implica- tions and applications of nanomaterials. Comments received during external review of the document suggested that NIOSH pri- oritize goals and projects so as to better understand the feasibility of conducting research based on available resources. In addition, specific suggestions on the scientific direction of the research program were also offered by reviewers, such as the need to understand the role of genetics. We have attempted to acknowledge these issues in finalizing this version of the strategic plan. This published version of the document will continue to exist on the NIOSH Web site and be updated periodically to reflect new research efforts. John Howard, M.D. /s Director, National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Strategic Plan for NIOSH Nanotechnology iii
  6. 6. Executive Summary Nanotechnology—the manipulation of mat- effort to identify and characterize the human ter on a near-atomic scale to produce new health hazards associated with nanomaterials. materials—has the potential to transform NIOSH will continue to play an active role in many industries, from medicine to manufac- this process. In June 2007, NIOSH reported turing, and the products they produce. Re- its progress in conducting nanotechnology search in nanoscale technologies continues research and drafting guidance for the safe to expand worldwide. By 2015, the National handling of nanomaterials [see report Prog- Science Foundation estimates that nano- technology will have a $1 trillion impact on ress Toward Safe Nanotechnology in the Work- the global economy and employ two million place: A Report from NIOSH Nanotechnol- workers, one million of whom will likely re- ogy Research Center at http://www.cdc.gov/ side in the United States. While this emerging niosh/topics/nanotech/, DHHS (NIOSH) technology holds great promise, it also pres- Publication No. 2007–123]. An update of the ents unknown risks, especially to the health progress report listing project updates from of workers. Many questions remain about 2007–2008 was published in November 2009 how to best manage and control the poten- [DHHS (NIOSH) Publication No. 2010–104]. tial hazards associated with the safe handling [http://www.cdc.gov/niosh/docs/2010-104/ of nanomaterials. Thus for the period 2009– pdfs/2010-104.pdf] 2012, NIOSH will collaborate with stake- holders at home and abroad to fill knowledge gaps related to nanotechnology, to identify NIOSH Nanotechnology and characterize hazards associated with Research Center (NTRC) nanomaterials, and to develop guidance for Given the rapid growth and global reach of workers exposed to nanomaterials. Protect- ing the health of workers involved with nan- nanotechnology, NIOSH established the otechnology is a global issue that requires Nanotechnology Research Center (NTRC) in international cooperation, commitment, and 2004 to conduct research and provide guid- collaboration. ance to protect workers involved with nano- materials. The NTRC and its Steering Com- Nanotechnology and NIOSH mittee consist of a diverse group of NIOSH Research scientists charged with overseeing the Insti- tute’s scientific and organizational plans in The rapid spread of nanotechnology threat- nanotechnology health research. ens to outpace knowledge about its attendant safety and health risks. As nanotechnology The main goals of the NTRC are to: moves forward into all avenues of commerce, stakeholders from industry, academia, labor, 1. Determine whether nanoparticles and occupational safety and health professions, nanomaterials pose risks of injuries and government must make a concerted and illnesses for workers. Strategic Plan for NIOSH Nanotechnology v
  7. 7. Executive Summary 2. Conduct research on applying nano- exposure limits (RELs). Conduct re- technology to the prevention of work- search on improving sampling and ana- related injuries and illnesses. lytical methods, determining the extent of workplace exposures, and control- 3. Promote healthy workplaces through ling airborne exposures below the REL. interventions, recommendations, and Identify what medical surveillance is capacity building. appropriate. Consider to what extent 4. Enhance global workplace safety and the observed relationship between TiO2 health through national and interna- particle size and toxicity can be general- tional collaborations on nanotechnol- ized to other metal oxides. ogy research and guidance. 4. Develop recommendations for con- trolling occupational exposures to Strategic Plan purified and unpurified single-walled With the input of a broad range of stake- carbon nanotubes (SWCNT) and holders in government, academia, and the multi-walled carbon nanotubes (MW- private sector, NIOSH developed a strategic CNT) including development of RELs. plan for nanotechnology research and guid- Conduct research to address gaps in ance. The strategic plan also highlights how information on sampling, analysis, ex- NIOSH’s critical research and guidance ef- posure assessment, instrumentation forts align with and support the National and controls. Identify what medical Nanotechnology Initiative’s Environmental surveillance or epidemiological studies Health and Safety priorities. For the period are appropriate. 2009–2012, NIOSH will continue to fill in- 5. Conduct research on how to identify formation and knowledge gaps in priority categories of nanoparticles that can be areas. Specifically, NIOSH will: distinguished on the basis of similar 1. Conduct toxicological research on physico-chemical properties. Conduct nanoparticles likely to be commercially research to develop RELs and ultimate- available. ly recommended exposure standards for these categories. 2. Conduct research to identify long- term health effects of carbon nano- 6. Conduct research on explosion poten- tubes (CNT). tial of various nanoparticles. 3. Develop recommendations for control- This plan proposes 38 activities in 10 criti- ling occupational exposure to fine and cal areas to help protect the nanotechnology ultrafine titanium dioxide (TiO2) in- workforce. It is a large challenge but one cluding development of recommended that NIOSH is well prepared to accept. vi Strategic Plan for NIOSH Nanotechnology
  8. 8. Abbreviations AIHA American Industrial Hygiene Association ACGIH American Conference of Governmental Industrial Hygienist ANSI American National Standards Institute ASSE American Society of Safety Engineers ASTM American Society for Testing and Materials ASSE American Society of Safety Engineers CAS chemical abstract system CDC Centers for Disease Control and Prevention CIB Current Intelligence Bulletin CNF carbon nanofibers CNT carbon nanotubes COPD chronic obstructive pulmonary disease CPSC Consumer Product Safety Commission DART Division of Applied Research and Technology DEP diesel exhaust particulate DHHS U.S. Department of Health and Human Services DOE U.S. Department of Energy ECHA European Chemicals Agency EHS environmental health and safety EPA U.S. Environmental Protection Agency ESLI end-of-service life indicator EU European Union FAQs frequently asked questions FMSH Federal Mine Safety and Health FY fiscal year Strategic Plan for NIOSH Nanotechnology vii
  9. 9. Abbreviations GIS geographical information systems HELD Health Effects Laboratory Division HEPA high-efficiency particulate air HPS Health Physics Society HPV high production volume HVAC heating, ventilation, and air conditioning IANH International Alliance for NanoEHS Harmonization ICON International Council on Nanotechnology ID identification IEC International Electrotechnical Commission IOM Institute of Occupational Medicine ILO International Labor Organization INRS Institut National de la Recherchè Scientifique ISO International Organization for Standardization ISPE International Society for Pharmaceutical Engineering IRSST Institut de recherché Robert–Sauvè en santé et en sécurité du travail MINChar Minimum Information Needed for Characterization of Nanomaterials MSDS material safety data sheet MSHA U.S. Mine Safety and Health Adminstration MWCNT multi-walled carbon nanotubes NASA National Aeronautics and Space Administration NCER National Center for Environmental Research NEHI Nanotechnology Environmental and Health Implications NGO non-governmental organization NIEHS National Institute of Environmental Health Sciences NIL Nanoparticle Information Library NIOSH National Institute for Occupational Safety and Health NIST National Institute of Standards and Technology viii Strategic Plan for NIOSH Nanotechnology
  10. 10. Abbreviations nm nanometer(s) NNI National Nanotechnology Initiative NORA National Occupational Research Agenda NSET Nanoscale Science, Engineering, and Technology NSF National Science Foundation NTRC Nanotechnology Research Center NSC National Safety Council OEP Office of Extramural Programs OECD Organization for Economic Cooperation and Development OELs occupational exposure limits OEP Office of Extramural Programs OSH occupational safety and health OSHA U.S. Occupational Safety and Health Administration PCAST Presidents Council of Advisors on Science and Technology POSS polyhedral oligomeric silsesquioxanes PPE personal protective equipment PPNANSG Project Planning Nanotechnology Strategic Goal PPNANIG Project Planning Nanotechnology Interim Goal PPNANAOG Project Planning Nanotechnology Activity/Output Goal QRA quantitative risk assessment r2p Research to Practice REL recommended exposure limit RFA request for application RM reference material ROS reactive oxygen species SWCNT single-walled carbon nanotubes TC technical committee TEM transmission electron microscopy Strategic Plan for NIOSH Nanotechnology ix
  11. 11. Abbreviations TiO2 titanium dioxide TNO Netherlands Organisation for Applied Scientific Research TWA time weighted average µg/m3 microgram per cubic meter UN United Nations VGCF vapor grown carbon fibers WHO World Health Organization WPMN Working Party on Manufactured Nanomaterials WPN Working Party on Nanotechnology x Strategic Plan for NIOSH Nanotechnology
  12. 12. Contents Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1 Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 NIOSH Logic Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2 Inputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.1 Congressional Mandate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2 Stakeholders’ Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.3 NIOSH Research Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.4 NIOSH Partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3 Activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.1 NIOSH Nanotechnology Research Center (NTRC) . . . . . . . . . . . . . . . . . . . . . 11 3.2 NTRC Steering Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.3 Current NIOSH Intramural Nanotechnology Research Activities . . . . . . . . . 11 3.4 Current NIOSH Extramural Nanotechnology Research Activities . . . . . . . . . 12 3.5 Collaborative Workshops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 4 Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.1 Goals and the Risk Management Continuum . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.2 Coordination with the National Nanotechnology Initiative . . . . . . . . . . . . . . 17 4.3 Strategic Goals, Intermediate Goals and Activity/Output Goals . . . . . . . . . . . 18 4.4 Coalescing Priorities for the NIOSH Research and Guidance for 2009–2012. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 5 Outputs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 5.1 NIOSH Publications on Nanotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 5.2 NIOSH Peer-reviewed Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 5.3 Sponsored Conferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 5.4 Presentations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 6 Research to Practice (r2p) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 6.1 Capacity Building through Technical Assistance. . . . . . . . . . . . . . . . . . . . . . . . 43 7 Intermediate Customers and Intermediate Outcomes . . . . . . . . . . . . . . . . . . . . . . 45 7.1 Federal Government Agencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 7.2 Standards Development Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Strategic Plan for NIOSH Nanotechnology xi
  13. 13. Contents 7.3 Industry, Labor, and Academia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 7.4 Professional Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 7.5 Research Collaborations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 7.6 International Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 8 Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Appendix A. Timeline for NIOSH Nanotechnology Research . . . . . . . . . . . . . . . . . . . 53 Appendix B. NNI Priority of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials . . . . . . . . . . . . . . . . . . . . . . . 67 Appendix C. Partnerships and Collaborations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 xii Strategic Plan for NIOSH Nanotechnology
  14. 14. Acknowledgments This report was developed by the scientists and staff of the National Institute for Occu- pational Safety and Health (NIOSH) who participate in the NIOSH Nanotechnology Re- search Center (NTRC). Paul Schulte is the manager and Charles Geraci is the coordinator of the NIOSH nanotechnology cross-sector program. Special thanks go to Laura Hodson and Ralph Zumwalde for writing and organizing the report. Others who contributed substantially to the strategic plan include: Eileen Birch, Vincent Castranova, Brian Curwin, Douglas Evans, Pengfei Gao, Mark Hoover, Vijia Karra, Bon- Ki Ku, Eileen Kuempel, Robert Mercer, Mark Methner, Arthur Miller, Vladimir Murashov, Terri Pearce, Appavoo Rengasamy, W. Allen Robison, Ronald Shaffer, Anna Shvedova, Petia Simeonova, Aleksandr Stefaniak, Jennifer Topmiller, Douglas Trout, and Leonid Turkevich. The NIOSH NTRC also acknowledges the contributions of Vanessa B. Williams, Gino Fazio, and Anne Stirnkorb for desktop publishing and graphic design, and Elizabeth Fryer for ed- iting the report. Mark Methner supplied the workplace photos in the document. Special appreciation is expressed to the following individuals and organizations for their external reviews and comments: David Warheit, Ph.D. William Gulledge Du Pont de Nemours American Chemistry Council Newark, NJ Arlington, VA Gurumurthy Ramachandran, Ph.D. James Melius, M.D., Dr.P.H. University of Minnesota Laborers’ Health and Safety Fund of North Minneapolis, MN America Albany, NY John Balbus, MPH, M.D. Environmental Defense Michael Ellenbecker, Ph.D. Washington D.C. University of Massachusetts Lowell, MA Michael Foster, Ph.D. Duke University Kristen Kulinowski, Ph.D. Durham, NC Rice University Houston, TX Robert Aitken, M.D. Institute of Occupational Medicine Lawrence Gibbs, MPH NanoSafe Europe Stanford University Edinburgh, UK Stanford, CA Strategic Plan for NIOSH Nanotechnology xiii
  15. 15. 1 Introduction 1.1 Background semiconductors, medical imaging, drug delivery systems, structural materials, sun- Nanotechnology is a system of innovative screens, cosmetics, coatings, and many oth- methods to control and manipulate matter er uses. Nanotechnology is one of the most at near-atomic scale to produce new ma- terials, structures, and devices. Nanopar- rapidly growing industries across the world. ticles are a specific class or subset of these By 2015, the global market for nanotechnol- new materials, having at least one dimen- ogy-related products is predicted to reach $1 sion that is less than 100 nanometers. They trillion and employ 1 million workers in the exhibit unique properties because of their United States alone [Lux 2007]. There are nanoscale dimensions. Nanotechnology of- currently over 1,000 commercial products fers the potential for tremendous improve- on the market (Figure 1).The properties of ment and advances in many areas that may nanoparticles (e.g., size, surface area, reac- benefit society, such as integrated sensors, tivity) that yield many of the far reaching Figure 1. Total nanomaterial containing products in the Wilson Center Consumer Product Inventory (used with permission from Project on Emerging Nanotechnologies Woodrow Wilson International Center for Scholars) Strategic Plan for NIOSH Nanotechnology 1
  16. 16. Chapter 1 ■ Introduction societal benefits may also pose risks. Cur- of the NNI is to facilitate scientific break- rently, increasing numbers of workers are throughs and maintain U.S. competitiveness potentially exposed to nanomaterials in in nanoscience. A stated goal of this interagen- research laboratories, start-up companies, cy program is to ensure that nanotechnology production facilities, and in operations research leads to the responsible development where nanomaterials are processed, used, of beneficial applications by giving high pri- disposed or recycled. The challenges are to ority to research on societal implications, hu- determine whether the nature of intention- man health, and environmental issues related ally produced (engineered) nanostructured to nanotechnology. materials and devices presents new occupa- tional safety and health risks. At the same The National Institute for Occupational time, there is a need to address how the Safety and Health (NIOSH) is the Federal benefits of nanotechnology can be realized agency responsible for conducting research while proactively minimizing the risk. and making recommendations to prevent work-related injury, illness, and death. Efforts across multiple federal agencies are NIOSH is a member of the Nanoscale Sci- fostering the development and use of nano- ence, Engineering and Technology (NSET) technology. In 2001, the President’s Council of Subcommittee of the National Science and Advisors on Science and Technology collabo- Technology Council. As such, NIOSH is rated with the interagency National Science active in (1) identifying critical issues re- and Technology Council to create the Nation- lated to possible hazards of nanomaterials, al Nanotechnology Initiative [NNI 2001]. This (2) protecting worker safety and health in initiative supports basic and applied research this emerging technology, and (3) develop- and development in nanotechnology to create ing a strategic plan to address such issues new nanomaterials and to disseminate new and recommend prevention strategies for technical capabilities to industry. The purpose the safe handling and use of nanomaterials. A nanotechnology researcher creating a slurry An electron micrograph of the personal breathing of carbon nanotubes. (Image courtesy of Mark zone sample collected from the researcher Methner, NIOSH) spraying the carbon nanotube slurry 2 Strategic Plan for NIOSH Nanotechnology
  17. 17. Chapter 1 ■ Introduction Because of their small size and large surface areas are: (1) toxicity and internal dose, area, engineered nanoparticles have chemi- (2) measurement methods, (3) exposure cal, physical, and biological properties dis- assessment, (4) epidemiology and surveil- tinctly different than fine particles of similar lance, (5) risk assessment, (6) engineering chemical composition. Such properties may controls and personal protective equipment include a high rate of pulmonary deposition, (PPE), (7) fire and explosion safety, (8) rec- the ability to travel from the lung to systemic ommendations and guidance, (9) commu- sites, the ability to penetrate dermal barriers, nication and information, and (10) applica- and a high inflammatory potency per mass. tions. By working in these critical research At a time when materials and commercial areas, NIOSH has comprehensively begun applications are being conceived, NIOSH is to address the information and knowledge positioned well to proactively identify, as- gaps necessary to protect workers and re- sess, and resolve potential safety and health sponsibly move nanotechnology forward issues posed by nanotechnology. NIOSH so that its far-reaching benefits may be real- has 38 years of experience in conducting ized. A summary of research projects may research and formulating recommenda- be found in Appendix A. tions for occupational safety and health. Congruent with the efforts of the NTRC During this period, NIOSH has developed are the efforts of the NIOSH Office of Ex- considerable expertise in measuring, char- tramural Programs (OEP). OEP uses several acterizing, and evaluating new processes mechanisms (R01, R21, R43/44) for funding and new materials by conducting quanti- research*. OEP funding of nanotechnology- tative exposure assessments and evaluating related research has been undertaken to help health effects. NIOSH also has expertise in increase the knowledge of nanotechnology developing control systems and prevention and engineered nanomaterials as they relate strategies for incidental nanoparticles (e.g., to occupational safety and health. Research diesel exhaust, welding fume, smelter fume, areas supported by NIOSH OEP include and fire smoke particles). NIOSH will reap- emission and exposure assessment methods ply this experience to address similar issues for nanoparticles in the workplace, toxicol- for engineered nanoparticles. ogy of engineered nanomaterials, and the In 2004, NIOSH created the Nanotechnol- use of nanotechnology for improved work- ogy Research Center (NTRC) to identify place monitoring. critical issues, create a strategic plan for NIOSH is working strategically to address the investigating these issues, coordinate the 10 critical research areas through active intra- NIOSH research effort, develop research mural and extramural research programs and partnerships, and disseminate information collaborations. NIOSH is committed to con- gained. The NTRC is comprised of nano- ducting and supporting studies that will im- technology-related activities and projects prove scientists’ abilities to identify potential consisting of and supported by more than occupational health effects of nanomaterials. 30 scientists from various NIOSH divi- NIOSH will facilitate the translation of those sions and laboratories. Through the NTRC, findings into effective workplace practices. NIOSH has identified 10 critical research areas for nanotechnology research and *NIOSH Office of Extramural Programs: http://www.cdc. communication. These 10 critical research gov/oep Strategic Plan for NIOSH Nanotechnology 3
  18. 18. Chapter 1 ■ Introduction Operations Inputs Activities Outputs Customers Outcomes Mission Management Annual Intermediate Strategic Objectives Goals Goals Goals Strategy and design External factors Figure 2. Schematic of the overall NIOSH logic model 1.2 NIOSH Logic Model materials, oral presentations, training and educational materials, tools, methods, and Like other scientific organizations, NIOSH technologies. NIOSH research outputs are can be described by a model of the way it transferred directly to the final customers functions to solve identified problems un- and partners (who implement improve- der various conditions. The overall NIOSH ments in workplace safety and health) or logic model is presented in Figure 2. It has a to intermediate customers (who transform conventional horseshoe shape with the op- further NIOSH outputs and produce in- erational upper branch proceeding from in- termediate outcomes). These intermediate puts to outcomes and with the strategic low- outcomes such as pilot technologies, train- er branch proceeding from strategic goals to ing programs, and regulations and stan- management objectives. Both branches are dards are forwarded to the final customers. correlated vertically and are subject to ex- Since NIOSH is not a regulatory agency, ternal factors. it relies heavily on efforts by intermedi- The NIOSH research program begins with ate and final customers to achieve ultimate an analysis of production and planning in- outcomes in the form of workplace safety puts and follows the NIOSH operational and health improvements. Effectiveness in model (Figure 3). This analysis determines achieving these ultimate outcomes is in- what can and should be done and thereby fluenced at all stages of program operation identifies research priorities. Intramural by both external factors (such as economic and extramural researchers present their and social conditions) and the regulatory project proposals which receive appropriate environment. Results of NIOSH-funded re- internal and external review and are fund- search and customer feedback (intermedi- ed based on proposal merits. Research ac- ate and final) contribute to the subsequent tivities produce outputs such as published rounds of program planning. 4 Strategic Plan for NIOSH Nanotechnology
  19. 19. Chapter 1 ■ Introduction Figure 3. Schematic of the NIOSH operational model Strategic Plan for NIOSH Nanotechnology 5
  20. 20. 2 Inputs 2.1 Congressional Mandate problems.” The Act specifies target areas of research that include identifying criteria for In the Occupational Safety and Health Act setting worker exposure standards and ex- of 1970 (OSH Act, Public Law 91–596) and ploring problems created by new technol- the Federal Mine Safety and Health Act of ogy in the workplace. In an amendment to 1977 (FMSH Act, Public Law 95–164), Con- the Act, NIOSH was given responsibility for gress declared that its purpose was to assure, conducting training and education “to pro- insofar as possible, safe and healthful work- vide an adequate supply of qualified person- ing conditions for every working man and nel to carry out the purposes of the Act” and woman to preserve our human resources. for assisting employers and workers with In these Acts, NIOSH is given the respon- applying methods to prevent occupational sibility for recommending occupational injuries and illness (Section 21 of the Act). safety and health standards and describing exposures that are safe for various periods of employment. These include (but are 2.2 Stakeholders’ Input not limited to) the exposures at which no As it follows from the OSH Act and the FMSH worker will suffer diminished health, func- Act, the major stakeholders of NIOSH are tional capacity, or life expectancy as a result the U.S. government (especially OSHA and of his or her work experience. By means of MSHA), workers, employers, occupational criteria documents and other publications, safety and health practitioners and research- NIOSH communicates these recommended ers, and the general public. NIOSH receives standards to regulatory agencies such as the input through formal committees such as the Occupational Safety and Health Adminis- NIOSH Board of Scientific Counselors, the tration (OSHA), the Mine Safety and Health National Advisory Committee on Occupa- Administration (MSHA), and others in the tional Safety and Health, and the Mine Safety occupational safety and health community. and Health Research Advisory Committee Occupational safety and health research for and through ad hoc mechanisms such as the mining industry was part of the U.S. the NIOSH Web site (www.cdc.gov/niosh), Bureau of Mines (Department of the Inte- the NIOSH toll-free telephone line (1–800– rior) until 1996 when those functions were CDC–INFO), personal contacts with oc- transferred to NIOSH as the Office for Mine cupational safety and health professionals, Safety and Health Research. and participation in professional conferences Under the OSH Act, NIOSH is charged and interagency committees. NIOSH also with conducting “research, experiments, provides stewardship of the National Occu- and demonstrations relating to occupa- pational Research Agenda (NORA) (http:// tional safety and health” and with devel- www.cdc.gov/niosh/nora), which is a frame- oping “innovative methods, techniques, work to guide occupational safety and health and approaches for dealing with [those] research into the new millennium—not only Strategic Plan for NIOSH Nanotechnology 7
  21. 21. Chapter 2 ■ Inputs for NIOSH but for the entire occupational area for immediate concern is in the work- safety and health community. place, where nanomaterials are being used or manufactured and where there is the The importance of Occupational Safety and greatest likelihood for exposures.” In 2008, Health issues to nanotechnology has been the President’s Council of Advisors on Sci- emphasized by the interagency working ence and Technology (PCAST) specifically group on Nanotechnology Environmental recommended “continuing acceleration of and Health Implications (NEHI), under the NIOSH funding, particularly for exposure NSET Subcommittee. NIOSH was formally assessment in the context of manufacturing invited to join the NEHI in 2004, and this and disposal of nanomaterials and prod- interagency effort has consistently encour- ucts incorporating relevant quantities of aged NIOSH to recognize nanotechnology nanomaterials” (PCAST, Addendum to the as one of its research priorities. National Nanotechnology Initiative: Second The importance of research on the occu- Assessment and Recommendations of the pational safety and health issues for nano- National Nanotechnology Advisory Panel, technology was further stressed at the Na- July 2008, available at http://www.ostp. tional Academies Review of the National gov/galleries/PCAST/PCAST%20Adden- Nanotechnology Initiative held on March dum%20Letter.pdf). 24–25, 2005. Richard Denison (Environ- Recognizing the importance of this research mental Defense) and Carol Henry (Ameri- area and of interagency collaboration, John can Chemistry Council), in their presen- Marburger (Director of the U.S. Office of tations to the National Academies review Science and Technology Policy) and Joshua panel, called for an increase in federal fund- Bolten (Director of the Office of Manage- ing of 10%, or $100 million, to address the ment and Budget) instructed the federal environmental, safety, and health issues of government “to ensure that nanotechnol- the nanotechnology industries. These calls ogy research leads to the responsible de- were further reiterated in a statement by velopment of beneficial applications, high Fred Krupp (President, Environmental De- priority should be given to research on fense) and Chad Holliday (Chairman and societal implications, human health, and CEO, DuPont) which was published in the environmental issues related to nanotech- June 14, 2005, issue of the Wall Street Jour- nology, and to develop, where applicable, nal: “An early and open examination of the cross-agency approaches to the funding potential risks of a new product or technol- and execution of this research” (July 8, 2005 ogy is not just good sense—it’s good busi- memorandum for the Heads of Executive ness strategy. . . . [G]overnment spending Departments and Agencies). on nanotechnology should be reprioritized so that approximately 10% goes to [health The NEHI working group 2006 publication and environmental risk].” E. Floyd Kvamme Environmental, Health, and Safety Research (Co-Chair of the President’s Council of Ad- Needs for Engineered Nanoscale Materials visors on Science and Technology), who was served as the basis for the NNI 2007 Strategy charged with guiding the NNI, stated in the for Nanotechnology-Related Environmental, June 24, 2005, issue of the Wall Street Jour- Health and Safety Research and identified nal that findings “indicated that the primary five priority environmental health and safety 8 Strategic Plan for NIOSH Nanotechnology
  22. 22. Chapter 2 ■ Inputs research needs: (1) instrumentation, me- particle surface radicals and activity, and trology, and analytical methods, (2) nano- in vitro and in vivo analysis of toxicity and materials and human health, (3) nanoma- pathogenesis. These laboratories are located terials and the environment, (4) health and in Spokane, Washington; Cincinnati, Ohio; environmental exposure assessment, and Pittsburgh, Pennsylvania; and Morgantown, (5) risk management methods (Appendix West Virginia. NIOSH researchers work B) [NNI 2007]. The NIOSH NTRC goals are closely with a broad range of scientists from reflective of these five priority environmen- industry, academia, and other government tal, health and safety areas. agencies. NIOSH involvement in national and international initiatives and programs NIOSH has also fostered stakeholder input is an important component of its capacity with trade associations, professional associa- to address critical occupational safety and tions, labor, and nongovernmental organiza- health issues in nanotechnology. tions. These collaborations have provided ex- pertise and resources critical for successfully reviewing research and for developing and 2.4 NIOSH Partnerships disseminating health and safety information NIOSH recognizes both the practical need on engineered nanoparticles. Some of the and the leadership obligation to extend its ongoing NIOSH NTRC stakeholders include internal capability by leveraging activities the American Industrial Hygiene Association and expertise found in other research institu- (AIHA), American Society of Safety Engi- tions, industries, federal agencies, and non- neers (ASSE), International Safety Equip- governmental organizations. These partner- ment Association and National Safety Coun- ships serve to deliver on multiple objectives; cil (NSC) (Appendix C). most importantly, they add to the body of knowledge on workplace health and safety 2.3 NIOSH Research issues associated with nanotechnology. Part- Capabilities nerships have taken several forms, ranging from formal letters or memoranda of under- The first-class research capability of NIOSH standing to informal working agreements on is an integral part of management’s inputs a specific topic. NIOSH will continue to pur- to the nanotechnology program. Within its sue partnerships as a means of achieving the divisions, NIOSH has world renowned re- goals of this strategic research plan and as an searchers who are trained and experienced effective vehicle to develop and disseminate in the full spectrum of necessary disciplines research results that can be translated into ranging from epidemiology to intervention practice that will lead to the positive impact effectiveness. Sections 3 and 5 of this docu- of helping nanotechnology move forward re- ment describe current NIOSH research sponsibly. activities including publications on nano- materials and NIOSH-sponsored meetings NIOSH has successfully used partnerships and conferences. In addition to their highly with industry specific to nanomaterial pro- qualified research staff, NIOSH has signifi- duction, to gain a better understanding of cant laboratory capabilities in particle mea- actual workplace exposures, practices, and surement, collection and characterization, controls that are in place. The field work that particle surface analysis, measurement of is conducted by NIOSH to assess exposures Strategic Plan for NIOSH Nanotechnology 9
  23. 23. Chapter 2 ■ Inputs to engineered nanomaterials represents on- workplace health and safety with the capa- going partnerships with numerous com- bilities of other organizations that are inves- panies. NIOSH will continue to develop tigating a specific element of the research these partnerships in order to receive input that is needed. Developing working rela- on accomplishing its objectives of develop- tionships with other research institutes pro- ing recommendations for the safe handling vides NIOSH with the information needed of nanomaterials; developing methods to to guide its own research and focus its lim- measure exposures to nanoparticles; evalu- ited resources in the most effective manner. ating controls that are, or could be, used in NIOSH has developed partnerships in the nanomaterial processes; evaluating the need areas of toxicology, risk assessment model- for and the effectiveness of PPE including ing, exposure measurement methods, con- respiratory protection; and developing com- trol technologies, filtration of nanoparticles, munication and information materials that and communication of research results and will assist industry in communicating with safe work practices. workers and the public. Several of the indus- trial partnerships NIOSH has developed have NIOSH broadens its activities with a wide provided opportunities from the beginning variety of collaborators and stakeholders of the nanotechnology program to identify by its participation in a number of national areas where additional research was needed. and international committees and working groups. This participation provides NIOSH Collaboration with other research institutes, the opportunity to provide and receive in- academia, and government provides NIOSH put on the key research that is needed to ad- the opportunity to combine its expertise in dress priority areas. 10 Strategic Plan for NIOSH Nanotechnology
  24. 24. 3 Activities 3.1 NIOSH Nanotechnology and updated as appropriate. Regular up- Research Center (NTRC) dates and progress reporting is managed through weekly teleconferences conducted by the NTRC. In addition, meetings are held Vision of the NTRC with appropriate stakeholders at least every other year. The vision of the NTRC is as follows: Safe nanotechnology by delivering on the 3.3 Current NIOSH Intramural Nation’s promise—safety and health at work for all people through research and Nanotechnology Research prevention. Activities Current NIOSH research activities in nan- otechnology are focused on occupational Mission of the NTRC safety and health implications. NIOSH has The mission of the NTRC is to provide na- expertise in developing control systems tional and world leadership for research and and prevention strategies for incidental guidance into the implications of nanopar- nanoparticles (e.g., diesel exhaust, welding ticles and nanomaterials for work-related fume, smelter fume, and fire smoke parti- injury and illness, and the application of cles). NIOSH is using this experience to ad- nanoparticles and nanomaterials in occupa- dress similar hazard, risk, and control issues tional safety and health. for engineered nanoparticles. It appears that nanomaterials that are presently manufac- tured and subsequently introduced into 3.2 NTRC Steering Committee products have no major physical features The NTRC Steering Committee is respon- that would make them behave differently sible for guiding NIOSH scientific and or- from fine or ultrafine particles in terms of ganizational plans in nanotechnology re- the ability to control them in the workplace search (including coordination for science [Methner 2008]. However, the limits of this and budget) and for developing strategic assumption need continued evaluation. Data goals and objectives and performance mea- from ongoing and proposed studies with sures for the NTRC. To ensure the respon- engineered nanoparticles are being used to siveness, relevance, and impact of NIOSH’s determine nanoparticle exposure concen- nanotechnology program, appropriate rep- trations in the workplace, hazards posed resentatives of its nanotechnology research by nanomaterials, and the risk of adverse program meet in person on an annual ba- health effects from occupational exposures sis to update strategic planning for nano- to nanomaterials. Studies are also provid- technology research. At these meetings, the ing data on the characteristics of nanoma- critical occupational safety and health issues terials produced and used in the workplace, arising from nanotechnology are reviewed routes of exposure, work practices, and Strategic Plan for NIOSH Nanotechnology 11
  25. 25. Chapter 3 ■ Activities engineering controls. Findings from these grants for three years and Exploratory (R21) intramural studies are providing scientific grants for two years. data to support the development of occupa- In FY07, NIOSH/OEP participated in RFA– tional safety and health recommendations. ES–06–008 Manufactured Nanomaterials: The timeline for conducting these research Physico-chemical Principles of Biocompat- activities with individual research projects is ibility and Toxicity. This RFA was jointly given in Appendix A. sponsored by NIEHS, EPA and NIOSH. 3.4 Current NIOSH Extramural In FY09, nanotechnology related research proposals submitted to standing program Nanotechnology Research announcements are being considered for Activities funding by NIOSH/OEP. The NIOSH Office of Extramural Programs From 2001–2009, NIOSH/OEP has commit- (OEP) manages the competitive process for ted about $5.2 million dollars to extramural awarding occupational safety and health nanotechnology research. Summaries of the grants and cooperative agreements to the projects funded by NIOSH/OEP up through research community outside the Institute. 2006 are included in the 2007 NIOSH Prog- This process includes peer review, program ress Toward Safe Nanotechnology in the Work- relevance, and priorities from the National place [NIOSH 2007a]. Summaries of projects Occupational Research Agenda (NORA), the from 2007–2008 are included in the 2009 re- NIOSH Research to Practice (r2p) initiative, port Progress Toward Safe Nanotechnology in congressional mandates, and sector, cross- the Workplace: A Report from the Nanotech- sector or coordinated emphasis areas of the nology Research Center: Project Reports for NIOSH Program Portfolio (http://www.cdc. 2007–2008 [NIOSH 2009c]. NIOSH/OEP gov/niosh/programs). plans to continue collaborative efforts with EPA/NCER, NSF, NIH/NIEHS, and other From 2001 to 2009, the Office of Extramural international agencies to support nanotech- Programs (OEP) has funded nanotechnol- nology research with occupational safety ogy research through Occupational Safety and health implications. OEP will continue and Health Research Program Announce- to confer with the NIOSH Nanotechnology ments (R01) and Small Business Innovation Research Center regarding issues, gaps, and Research Grants (R43/44). Since FY05, OEP future directions. has also participated in two joint Requests for Applications (RFAs) for Nanotechnol- ogy Research Grants Investigating Envi- 3.5 Collaborative Workshops ronmental and Human Health Issues. The In FY05, NIOSH co-sponsored the 1st Inter- US Environmental Protection Agency’s Na- national Symposium on Nanotechnology tional Center for Environmental Research and Occupational Health in Buxton, Unit- (NCER) and the National Science Founda- ed Kingdom, and The First International tion (NSF) participated in FY05. The Na- Conference on Nanotoxicology: Biomedi- tional Institute of Environmental Health cal Aspects in Miami, FL. In FY06, NIOSH Sciences (NIEHS) joined in FY06. Funding co-sponsored the 2nd International Sym- was available to support Research (R01) posium on Nanotechnology and Health in 12 Strategic Plan for NIOSH Nanotechnology
  26. 26. Chapter 3 ■ Activities Minneapolis, MN. In FY07, NIOSH collabo- Screening of Workers Potentially Exposed to rated with the International Aerosol Research Engineered Nanoparticles. In FY07, NIOSH Assembly and the American Association for co-sponsored the 3rd International Sympo- Aerosol Research to hold an International sium on Nanotechnology Safety & Health in Symposium on Nanotechnology and Health Taipei, Taiwan. In FY08, NIOSH participated in conjunction with the International Aero- in the planning of the 4th International Con- sol Conference in St. Paul, Minnesota. In gress on Nanotechnology Safety and Health FY07, NIOSH and the University of Cincin- held in August 2009, in Helsinki, Finland. In nati co-sponsored the International Confer- FY08, NIOSH co-sponsored The Second In- ence on Nanotechnology Occupational and ternational Conference on Nanotoxicology Environmental Health and Safety: Research in Zurich, Switzerland and Organization for to Practice, in Cincinnati, OH. In FY07, Economic Co-operation and Development NIOSH convened a collaborative workshop workshop on Exposure Assessment and Ex- including representatives from government, posure Mitigation in Frankfurt, Germany. In academia, labor, and industry in Washing- FY09, NIOSH co-sponsored a National Insti- ton, DC, to review a draft document devel- tute of Standards and Technology Workshop oped by NIOSH and a cross agency work on Enabling Standards for Nanomaterial group, titled Interim Guidelines on Medical Characterization in Gaithersburg, MD. Strategic Plan for NIOSH Nanotechnology 13
  27. 27. 4 Goals 4.1 Goals and the Risk to be introduced into the workplace and the Management Continuum workforce exposed to these materials be- comes more diversified. The challenge has A complete process for managing occupa- been to conduct research to address knowl- tional safety and health implications during edge gaps while drawing on all available in- the development of new technologies and formation to provide interim occupational materials consists of a set of progressive el- safety and health guidance. Toxicological ements: identifying and characterizing the research is an important element of the hazard, assessing the extent of exposure, risk management paradigm that frequently characterizing the risk, and developing con- forms the foundation for occupational safe- trol and management procedures [Schulte ty and health recommendations. NIOSH et al. 2008]. As exposure assessment data has identified this as a high priority and will become available, a determination can be continue to conduct research to identify the made whether or not an occupational risk critical routes of exposure (respiratory and exists, and if so, the risk can be assessed and skin), their targets (lungs, cardiovascular, characterized. A goal of the risk character- skin, brain, systemic), health outcomes, and ization is to determine whether exposure to mechanisms of action for specific nano- a given technology or type of material (in materials. Concurrent with this research, this case, nanomaterials) is likely to result in research is being conducted on measuring adverse health effects. Exposure assessment nanoparticles in air, determining what mea- data also provide a means to determine what sures are appropriate, and using this infor- controls are effective in preventing expo- mation in field assessments to determine sure that could cause adverse health effects. what workers are at risk for exposure. Paral- The NIOSH NTRC is involved in answer- lel efforts have also been undertaken to ad- ing questions posed in each element in the dress the control of airborne nanoparticles, risk management process. Figure 4 provides nanotubes and nanofibers and the strengths a visual representation of the risk manage- and weaknesses of control approaches. ment process and the NIOSH research as- Similar efforts are underway for personal sociated with each step. protective equipment (PPE) such as respi- rators and gloves. While the primary focus NIOSH has begun to address its NTRC stra- of research will be to address the elements tegic goals through the initiation of research of “hazard identification” “hazard charac- to address each element of the risk manage- terization” and “exposure assessment” of the ment process as illustrated in Figure 4. The risk management paradigm, the level of re- problem is that it is difficult to proceed in search will be limited by available resources. a classic step by step research approach in Thus, the focus of research from year-to- a timely manner to address the elements of year may change based on available resourc- hazard identification through risk manage- es and the need to address specific knowl- ment because new nanomaterials continue edge gaps. As findings of field investigations Strategic Plan for NIOSH Nanotechnology 15
  28. 28. Chapter 4 ■ Goals Figure 4. Steps to protect workers involved with nanotechnology 16 Strategic Plan for NIOSH Nanotechnology
  29. 29. Chapter 4 ■ Goals Mixer/sonicator/attrition mill within ventilated enclosure (Image courtesy of Mark Methner, NIOSH) and laboratory research become available safety and health through national and in- the information will be used to develop and ternational collaborations on nanotechnol- update guidance for evaluating and manag- ogy research and guidance” cross-cuts all 10 ing potential nanotechnology risks. critical research areas, intermediate goals were developed for this area. Ongoing and The strategic goals are being addressed by projected research within each of the 10 conducting research in the 10 critical re- critical research areas through 2012 is de- search areas identified by the NIOSH NTRC: scribed in Appendix A. Projected research (1) toxicity and internal dose, (2) measure- for 2009–2012 has been coalesced to focus ment methods, (3) exposure assessment, on specific research priorities (see section (4) epidemiology and surveillance, (5) risk 4.4). As knowledge gaps are filled and as re- assessment, (6) engineering controls and sources become available these research pri- PPE, (7) fire and explosion safety, (8) recom- orities could change. mendations and guidance, (9) communica- tion and information, and (10) applications. 4.2 Coordination with the Research conducted in each of the critical areas is intended to address specific interme- National Nanotechnology diate goals and performance measures (see Initiative Section 4.3). Additionally, since the fourth NIOSH participates in the National Nano- strategic goal “Enhance global workplace technology Initiative’s (NNI) “Strategy for Strategic Plan for NIOSH Nanotechnology 17
  30. 30. Chapter 4 ■ Goals Nanotechnology Environmental Health and Safety Research.” Table 1 shows the align- ment of the four NIOSH NTRC strategic goals and the 10 NTRC critical research ar- eas with the NNI environmental health and safety (EHS) priority research needs (see Appendix B). Planned projects within each of the 10 NIOSH critical research areas meet one or more of the four NIOSH Strategic Goals. A check mark () means that a goal is addressed by projects within the critical research area. Alpha-numerical identifica- tions indicate alignment of the NIOSH crit- Weighing carbon nanotubes in an exhausted en- closure (Image courtesy of Mark Methner, NIOSH) ical research goals with the NNI EHS prior- ity environmental health and safety areas. the unique properties of engineered nano- materials pose occupational health risks. 4.3 Strategic Goals, These uncertainties arise because of gaps in Intermediate Goals and knowledge about the potential routes of ex- posure, movement of nanomaterials once Activity/Output Goals they enter the body, and the interaction of the The NIOSH Nanotechnology Research materials with the body’s biological systems. Center (NTRC) has developed the following Results from existing studies in animals and strategic goals based on inputs from stake- humans on exposure to incidental nanoscale holders and partners: and respirable particles provide preliminary information upon which to develop a re- Strategic Goal 1 (PPNANSG1). search strategy to assess the possible adverse health effects from exposures to engineered Determine if nanoparticles and nanomate- nanomaterials. rials pose risks for work-related injuries and illnesses. Activity/Output Goal 1.1.1 (PPNANAOG1.1.1) Key factors and mechanisms. Systematically Intermediate Goal 1.1 (PPNANIG1.1): investigate the physical and chemical prop- Conduct research to contribute to erties of particles that influence their toxic- the understanding of the toxicology ity (e.g., size, shape, surface area, solubility, and internal dose of nanomaterials. chemical properties, and trace components). Evaluate acute and chronic effects in the NIOSH has studied in great detail the toxic- lungs and in other organ systems and tissues. ity of incidental exposures to nanoparticles Determine rates of clearance of nanopar- generated from processes involving combus- ticles after pulmonary exposure and trans- tion, welding, or diesel engines. However, less location to systemic organs; characterize is known about nanoparticles that are inten- systemic effects. Determine dermal response tionally produced (engineered) with diam- to exposure to skin and quantitative penetra- eters or structures smaller than 100 nanome- tion of nanoparticles into skin. Determine ters. Many uncertainties exist as to whether the biological mechanisms for toxic effects 18 Strategic Plan for NIOSH Nanotechnology
  31. 31. Chapter 4 ■ Goals Table 1. Alignment of critical research areas with the four strategic goals of the NIOSH NTRC and the NNI EHS priority environmental health and safety areas Determine if Conduct research Promote healthy nanoparticles and on applying nano- workplaces nanomaterials pose technology to the through inter- risks for work- prevention of work- ventions, recom- Enhance global NIOSH NTRC related injuries and related injuries and mendations, and workplace safety 1 strategic goals illnesses illnesses capacity building and health1 Toxicity and inter- 3, A24, B1, B2,  nal dose B3, B4, B5 Measurement , A1, A2, A3, A4,  , E1  methods A5, B2 Exposure assess- , A1, A2, D1, D4, , E2  ment2 D5, E1, E2 Epidemiology and , D1, D2, D3, , E4  surveillance D4, E4 Risk , A2, B1, B2, D4, , E3, E5  assessment E3 Engineering con- , D5  , E1  trols and PPE Fire and explosion , A2  safety Recommendations , E1, E5  and guidance Communication , E1, E5  and information Applications   1 The NNI EHS plan does not address applications or global activities pertaining to environmental health and safety of nanomaterials. However the NIOSH efforts described herein are consistent with the over- all NNI strategy which does identify international opportunities for collaboration. 2 NIOSH is the lead agency for the NNI EHS Strategic area on human and environmental exposure assess- ment. 3 A  indicates that a goal is addressed by projects within the NIOSH critical research area 4 Alpha-numeric identifications indicate alignment of the NIOSH critical research area with the specific NNI priority research needs (see Appendix B). Strategic Plan for NIOSH Nanotechnology 19
  32. 32. Chapter 4 ■ Goals (e.g., role of oxidant stress), including from exposure to inhalation, and the relevance of mixed exposures, and how the key chemi- animal studies to human response. cal and physical factors may influence these Performance measure 1.1.2 Determine the mechanisms. Determine if nanoparticles are role of oxidant-generating potential in bio- genotoxic/carcinogenic. activity of metal oxide nanoparticles and Performance measure 1.1.1 Determine the carbon nanotubes over the next three years. pulmonary response (dose dependence and Determine the role of shape (nanospheres time course) to single-walled carbon nano- vs. nanowires) in bioactivity over the next tubes (SWCNT) within the next two years and three years. Determine the role of carbon multi-walled carbon nanotubes (MWCNT) nanotube diameter and length in bioactiv- within the next three years. Determine the car- ity over the next four years. Develop in vi- diovascular response to pulmonary exposure tro assays for oxidant generation, fibrogenic to SWCNT and ultrafine titanium dioxide potential, and ability to cause endothelial within the next two years. Determine the pul- dysfunction over the next four years. These results will address the development of pre- monary deposition and fate of SWCNT within dictive algorithms for toxicity over the next the next two years and MWCNT and ultrafine five years. titanium dioxide within the next three years. Determine the in vitro effects of SWCNT and Activity/Output Goal 1.1.3 (PPNANAOG1.1.3) metal oxide nanoparticles on skin cells within Metrics of dose. Determine whether (1) par- the next two years and the in vivo effects of ticle number, surface area, or other measure topical exposure within the next three years. of bioavailability or bioactivity is a more ap- Determine the genotoxic and carcinogenic propriate dose metric for toxicity than mass effects of SWCNT within the next four years. or (2) other measures of bioavailability may Determine the central nervous system effects be useful (e.g., an integrated measure of re- of pulmonary exposure to nanoparticles with- tention, solubility, oxidant-generating poten- in the next four years. Determine the pulmo- tial, surface area, and binding reactivity for nary and systemic effects of other nanoparti- proteins/lipids). cles with the next five years. These results will Performance measure 1.1.3 Determine the elucidate toxicological mechanisms over the pulmonary response to exposure to fine vs. ul- next five years. trafine particles using both mass and surface Activity/Output Goal 1.1.2 (PPNANAOG1.1.2) area as the dose metric. Determine the role of Predictive models for toxicity. Integrate oxidant generation in the bioactivity of metal mechanistic models (including animal mod- oxide nanoparticles and carbon nanotubes. els and in vitro screening tests) for assessing These results will address issues of most ap- propriate dose metric over the next three years. the potential toxicity of new nanomaterials and provide a basis for developing predic- Activity/Output Goal 1.1.4 (PPNANAOG1.1.4) tive algorithms for structure/function rela- Internal dose. Determine the fate, clearance, tionships and comparative toxicity analyses and persistence of nanomaterials in the body for risk assessment. Evaluate the relation- (i.e., pulmonary, lymphatics, blood/systemic, ship between in vitro and in vivo responses, brain) including possible de-agglomeration the relevance of instillation or aspiration of nanoparticle agglomerates into primary 20 Strategic Plan for NIOSH Nanotechnology
  33. 33. Chapter 4 ■ Goals particles and translocation of nanomaterials over the next five years and establish a suite from the lung to systemic organs. of instruments and protocols for nanoparti- cle measurement in the workplace. Contin- Performance measure 1.1.4 Develop meth- ue with refining the NIOSH method 5040 ods to label carbon nanotubes and track their specifications for the collection and analysis pulmonary deposition and fate (i.e., clearance, of elemental and organic carbon for appli- interstitialization, and translocation) with cation to the collection and analysis of car- time post-exposure. Use chemical analysis to bon nanotubes and nanofibers. track the deposition and fate of metal oxide nanoparticles. These results will address issues Activity/Output Goal 1.2.2 (PPNANAOG1.2.2) of internal dose over the next five years. Develop new measurement methods. Ex- pand the currently available instrumenta- Intermediate Goal 1.2 (PPNANIG1.2): tion by developing and field testing methods Conduct research to evaluate mea- that can accurately measure workplace air- surement methods for nanomaterials. borne exposure concentrations of nanoma- terials using metrics associated with toxicity Scientifically credible measurement methods (e.g., particle surface area, particle number). are essential in order to effectively anticipate, recognize, evaluate, and control potential Performance measure 1.2.2 Support at least occupational exposures from current and three research projects over the next three emerging nanotechnologies. Traditional mea- years with the goal of creating a measure- surement approaches, such as determining ment method that can be correlated with total and respirable dust concentrations, may the metrics associated with toxicity. Within not be adequate for analyzing nanomaterials five years develop a handheld fast-response due to their unique physical, chemical, and nanoparticle monitor and software for spa- biological properties. tial mapping of nanoparticles. Activity/Output Goal 1.2.1 (PPNANAOG1.2.1) Activity/Output Goal 1.2.3 (PPNANAOG1.2.3) Extend existing measurement methods. Validation of measurement methods. De- Evaluate current methods for measuring velop testing and evaluation systems for airborne mass concentrations of respirable comparison and validation of nanoparticle particles in the workplace and determine sampling instruments and methods. whether these mass-based methods can be used as an interim approach for measuring Performance measure 1.2.3 Within three nanomaterials in the workplace and to main- years publish procedures for validation of tain continuity with historical methods. nanoparticle sampling instruments and methods. Performance measure 1.2.1 Within three years evaluate the correlation between par- Activity/Output Goal 1.2.4 (PPNANAOG1.2.4) ticle number, surface area, mass, and parti- Standard reference materials. Identify and cle size distribution airborne measurement qualify scientifically credible, nanoscale cer- results and provide guidance for sampler tified reference materials (RMs) with as- selection based on the nanomaterial of in- signed physical and/or chemical values for terest. Continue to conduct measurement use in evaluating measurement tools, in- studies of nanoparticles in the workplace struments, and methods. Strategic Plan for NIOSH Nanotechnology 21
  34. 34. Chapter 4 ■ Goals Performance measure 1.2.4 Within three Activity/Output Goal 1.3.2 (PPNANAOG1.3.2) years strengthen interactions with the Na- Worker exposures. Quantitatively assess ex- tional Institute of Standards and Technol- posures to nanomaterials in the workplace ogy to identify commercially available RMs including inhalation and dermal exposure. and perform coherent research to identify, Determine how exposures differ by work task develop, and qualify nanoscale RMs and or process. benchmark materials for evaluating mea- surement tools, instruments, and methods. Performance measure 1.3.2 Within three years develop a baseline worker exposure as- sessment that identifies how exposures dif- Intermediate Goal 1.3 (PPNANIG1.3): fer by work task or process. Conduct nanomaterial workplace exposure assessments. Intermediate Goal 1.4 (PPNANIG1.4): Exposure assessment is a critical component Conduct epidemiologic research and in determining whether nanomaterials pose evaluate surveillance of nanomate- occupational safety or health risks. There- rial workers. fore, it is necessary to conduct exposure as- sessments in the workplace to identify the Currently, human studies of exposure and ways that workers may be exposed to nano- response to engineered nanomaterials are materials, the amount of exposure that may not available. Gaps in knowledge and un- occur, and the frequency of potential expo- derstanding of nanomaterials must be filled sure. Without workplace exposure data, it is before epidemiologic studies can be per- difficult to accurately characterize the work formed. For example, improvements in ex- environment, identify sources that are emit- posure assessment will allow researchers to ting nanomaterials, or estimate the amount identify groups of workers likely exposed to of nanoparticle exposure that workers may nanomaterials. In turn, health studies con- receive. In addition, exposure data can be ben- ducted on these worker-groups can pro- eficial when making decisions concerning risk vide useful information about the potential management or evaluating the effectiveness of health risks associated with nanomaterials. engineering controls and work practices in re- Until such studies can be conducted effec- ducing worker exposures. tively, studies of humans exposed to other Activity/Output Goal 1.3.1 (PPNANAOG1.3.1) aerosols (i.e., larger respirable particles) can Fate of nanomaterials in the work environ- be used to evaluate the potential health risks ment. Determine the key factors influencing to airborne nanomaterials. the generation, dispersion, deposition, and Activity/Output Goal 1.4.1 (PPNANAOG1.4.1) re-entrainment of nanomaterials in the work- Evaluate current knowledge. Critically eval- place, including the role of mixed exposures. uate existing exposure and health data for Performance measure 1.3.1 Support at least workers employed in workplaces where nano- 12 research projects (industry exposure as- materials are produced and used. Determine sessments) over the next three years to as- what is known about exposure response to sess the fate of nanomaterials in the work existing nanomaterials, evaluate the applica- environment. bility of this information to new nanomateri- 22 Strategic Plan for NIOSH Nanotechnology
  35. 35. Chapter 4 ■ Goals als, and identify data gaps and epidemiological infrastructure to enable effective and eco- research needs. nomical development and sharing of nano- technology safety and health data. Performance measure 1.4.1 Over the next three years, seek input from a collaborative Performance measure 1.4.4 By 2012 create working group made up of representatives a GIS infrastructure populated with nano- from industry, government, academia, and technology exposure data. labor concerning the value and utility of es- tablishing exposure registries for workers po- Intermediate Goal 1.5 (PPNANIG1.5): tentially exposed to engineered nanoparticles. Conduct a risk assessment for high volume nanomaterials. Activity/Output Goal 1.4.2 (PPNANAOG1.4.2) New epidemiological studies. Evaluate the In the context of occupational safety and need for and feasibility of initiating epide- health, risk assessment can be described as miological or other health studies in work- a scientific evaluation of the potential for ers exposed to existing nanomaterials (e.g., adverse health and safety effects to workers carbon black) or producing and using new exposed to hazardous substances. When as- (engineered) nanomaterials. sessing risk, it must be determined whether Performance measure 1.4.2 Over the next a hazard is present and the extent to which a three years assess the feasibility of industry- worker is likely to be exposed to the hazard. wide exposure and epidemiological studies of Risk involves both the presence of a hazard- workers exposed to engineered nanomaterials. ous agent and the potential for exposure to that agent. Quantitative and qualitative risk Activity/Output Goal 1.4.3 (PPNANAOG1.4.3) assessment methods are used to evaluate risk. Surveillance. Integrate nanotechnology safe- ty and health issues into existing hazard sur- Activity/Output Goal 1.5.1 (PPNANAOG1.5.1). veillance mechanisms. Determine whether Evaluate current studies. Determine to these mechanisms are adequate or whether what extent current exposure-response data additional screening or surveillance methods (human or animal) for fine and ultrafine are needed. particles may be used to identify and assess potential occupational hazards and risks to Performance measure 1.4.3 Update within nanomaterials. three years the recommendations given in the NIOSH Current Intelligence Bulletin 60 Performance measure 1.5.1 Within three “Interim Guidance for the Medical Screening years complete a quantitative risk assessment and Hazard Surveillance of Workers Poten- (QRA) on ultrafine and fine materials from tially Exposed to Engineered Nanoparticles” existing studies. Evaluate QRA methods for [NIOSH 2009]. Investigate the feasibility of nanomaterials. Start QRA for nanoparticles establishing a registry of workers exposed to using new NIOSH data. Use NIOSH nanopar- engineered nanoparticles. ticle data to calibrate and validate dosimetry models for nanoparticles. Activity/Output Goal 1.4.4 (PPNANAOG1.4.4) Nanotechnology health information sys- Activity/Output Goal 1.5.2 (PPNANAOG1.5.2) tems. Build on existing public health geo- Risk assessment framework. Develop a risk graphical information systems (GIS) and assessment framework for evaluating the Strategic Plan for NIOSH Nanotechnology 23
  36. 36. Chapter 4 ■ Goals hazard and predicting the risk of exposure findings to workers, employers, and occupa- to nanoparticles. tional safety and health professionals. Performance measure 1.5.2 Within five years develop a risk assessment framework to Strategic Goal 3 (PPNANSG3). rank hazard and estimate risk from exposure Promote healthy workplaces through to selected nanoparticles in the workplace. interventions, recommendations, and capacity building. Strategic Goal 2 (PPNANSG2). Conduct research to prevent work- Intermediate Goal 3.1 (PPNANIG3.1): related injuries and illnesses by Conduct research to better understand applying nanotechnology products. engineering controls and personal protective equipment (PPE) for use with nanomaterials. Intermediate Goal 2.1 (PPNANIG2.1): Conduct research to evaluate potential Currently there are no exposure standards applications of nanomaterials for specific to engineered nanomaterials. There- occupational safety and health. fore, to evaluate the need for and effective- The unique properties and characteristics of ness of engineering controls an alternative nanomaterials may provide the basis for in- rationale is required. In addition, the success novative new devices, products, or processes of emerging nanotechnology industries will to reduce risks of work-related injuries and depend on production and development illnesses. Such innovations may have proper- costs, including the installation of new expo- ties or capabilities that cannot be created or sure controls. Minimizing occupational ex- manufactured using conventional materials. posure to the lowest possible level is the most prudent approach for controlling materials Activity/Output Goal 2.1.1 (PPNANAOG2.1.1) New devices and uses. Identify uses of nano- of unknown toxicity, such as nanomaterials. technology in occupational safety and health. Typically, these approaches include substitut- ing a less toxic material if possible, enclosing Performance measure 2.1.1 Support at least the hazardous process, removing workers three projects over the next three years to from the exposure by automating the pro- evaluate the application of nanotechnology cess, isolating workers from the hazard, and/ in the manufacture of filters, respirators, and or utilizing local exhaust ventilation where respirator cartridge end-of-service indicator. nanomaterials are handled. Improved con- Activity/Output Goal 2.1.2 (PPNANAOG2.1.2) trol approaches will become more evident Dissemination. Evaluate and disseminate as the risks of exposure to nanomaterials are effective nanotechnology research findings better understood. that may have applications to new sensors, Activity/Output Goal 3.1.1 (PPNANAOG3.1.1) PPE or other nanotechnology health and Engineering controls. Evaluate the effective- safety applications. ness of engineering control techniques for Performance measure 2.1.2 Within five years nanoaerosols and develop new approaches as publish application findings and disseminate needed. 24 Strategic Plan for NIOSH Nanotechnology
  37. 37. Chapter 4 ■ Goals Performance measure 3.1.1 Conduct field Performance measure 3.1.5 Within three investigations of workplaces where nanopar- years publish a document on the suitability ticles are manufactured and used and evalu- of control banding approaches for nanoma- ate existing engineering controls. Within terials. three years publish updated engineering con- Activity/Output Goal 3.1.6 (PPNANAOG3.1.6) trol guidance. Substitute materials. Evaluate the feasibility Activity/Output Goal 3.1.2 (PPNANAOG3.1.2) and effectiveness of substitute materials or Personal protective equipment (PPE). Eval- modification of the engineered nanoparticle uate and improve the effectiveness of PPE for in reducing the toxicity of nanomaterials. reducing worker exposures to nanomaterials. Performance measure 3.1.6 Support at Performance measure 3.1.2 Within five least three projects over the next five years to years publish updated guidance on the ef- evaluate substitute and modified nanopar- fectiveness of PPE for reducing worker ex- ticles with toxicological studies. posures to nanoparticles. Activity/Output Goal 3.1.3 (PPNANAOG3.1.3) Intermediate Goal 3.2 (PPNANIG3.2): Respirators. Evaluate the effectiveness of Conduct research to better define NIOSH-approved air purifying respirators the potential fire and explosion to determine whether existing respirator safety hazards of nanomaterials. guidelines would still apply for workers ex- posed to nanoaerosols. The field of nanotechnology is relatively new, and therefore little is known about the po- Performance measure 3.1.3 Within five tential occupational safety hazards that may years publish updated respiratory protec- be associated with engineered nanomaterials. tion guidance. However, the information that is available Activity/Output Goal 3.1.4 (PPNANAOG3.1.4) about the properties of nanoscale particles Work practices. Evaluate the role of work indicates that under given conditions, engi- practices and administrative controls in re- neered nanomaterials may pose a dust explo- ducing potential exposures to nanomateri- sion hazard and be spontaneously flammable als. Make recommendations for appropriate when exposed to air due to their large surface and effective use of these approaches. area and overall small size. Until more spe- Performance measure 3.1.4 Within five cific data become available, NIOSH NTRC years publish updated work practice and is utilizing findings from research studies in- administrative control guidance. volving particles smaller than 100 nanome- ters to evaluate the potential risk for fire and Activity/Output Goal 3.1.5 (PPNANAOG3.1.5) explosion of airborne nanoparticles. Control banding. Evaluate the suitability of a qualitative risk management approach Activity/Output Goal 3.2.1 (PPNANAOG3.2.1) similar to control banding to develop guid- Explosion and fire hazards. Identify physi- ance for working with engineered nanoma- cal and chemical properties that contribute terials when there is insufficient information to dustiness, combustibility, flammability, available to apply traditional exposure- and conductivity of nanomaterials. Inves- limit—based control strategies. tigate and recommend appropriate work Strategic Plan for NIOSH Nanotechnology 25

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