Nanotechnology

Strategic Plan for NIOSH Nanotechnology Research: Filling the Knowledge Gaps

I. Introduction

1.1 Background

Nanotechnology is a system of innovative methods to control and manipulate matter at near-atomic scale to produce new materials, structures, and devices. Nanoparticles are a specific class or subset of these new materials, having at least one dimension that is less than 100 nanometers. They exhibit unique properties because of their nanoscale dimensions. Nanotechnology offers the potential for tremendous improvement and advances in many areas than may benefit society, such as integrated sensors, semiconductors, medical imaging, drug delivery systems, structural materials, sunscreens, cosmetics, coatings, and many other uses. Nanotechnology is one of the most rapidly growing industries across the world. By 2015, the global market for nanotechnology-related products is predicted to reach $1 trillion and employ 1 million workers in the United States alone. The properties of nanoparticles (e.g., size, surface area, reactivity) that yield many of the far reaching societal benefits may also pose risks. Currently, increasing numbers of workers are potentially exposed to nanomaterials in research laboratories, start-up companies, production facilities, and in operations where nanomaterials are processed, used, disposed or recycled. The challenges are to determine whether the nature of intentionally produced (engineered) nanostructured materials and devices presents new occupational safety and health risks. At the same time, there is a need to address how the benefits of nanotechnology can be realized while proactively minimizing the risk.

Efforts across multiple federal agencies are fostering the development and use of nanotechnology. The President’s Council of Advisors on Science and Technology has collaborated with the interagency National Science and Technology Council to create the National Nanotechnology Initiative (NNI). This initiative supports basic and applied research and development in nanotechnology to create new nanomaterials and to disseminate new technical capabilities to industry. The purpose of NNI is to facilitate scientific breakthroughs and maintain U.S. competitiveness in nanoscience. A stated goal of this interagency program is to ensure that nanotechnology research leads to the responsible development of beneficial applications by giving high priority to research on societal implications, human health, and environmental issues related to nanotechnology.

The National Institute for Occupational Safety and Health (NIOSH) is the Federal agency responsible for conducting research and making recommendations to prevent work-related injury, illness, and death. NIOSH is a member of the Nanoscale Science, Engineering and Technology (NSET) Subcommittee of the National Science and Technology Council. As such, NIOSH is active in (1) identifying critical issues related to possible hazards of nanomaterials, (2) protecting worker safety and health in this emerging technology, and (3) developing a strategic plan to address such issues and recommend prevention strategies for the safe handling and use of nanomaterials.

Because of their small size and large surface area, engineered nanoparticles have chemical, physical, and biological properties distinctly different than fine particles of similar chemical composition, thus making them attractive for commercial development and application. Such properties may include a high rate of pulmonary deposition, the ability to travel from the lung to systemic sites, the ability to penetrate dermal barriers, and a high inflammatory potency per mass. At a time when materials and commercial applications are being conceived, NIOSH is positioned well to proactively identify, assess, and resolve potential safety and health issues posed by nanotechnology. NIOSH has 38 years of experience in conducting research and formulating recommendations for occupational safety and health. During this period, NIOSH has developed considerable expertise in measuring, characterizing, and evaluating new processes and new materials by conducting quantitative exposure assessments and evaluating health effects. NIOSH also has expertise in developing control systems and prevention strategies for incidental nanoparticles (e.g., diesel exhaust, welding fume, smelter fume, and fire smoke particles). NIOSH will reapply this experience to address similar issues for engineered nanoparticles.

In 2004, NIOSH created the Nanotechnology Research Center (NTRC) to identify critical issues, create a strategic plan for investigating these issues, coordinate the NIOSH research effort, develop research partnerships, and disseminate information gained. The NTRC is comprised of nanotechnology-related activities and projects consisting of and supported by more than 30 scientists from various NIOSH divisions and laboratories. Through the NTRC, NIOSH has identified 10 critical research areas for nanotechnology research and communication. These 10 critical research areas are: (1) exposure assessment, (2) toxicity and internal dose, (3) epidemiology and surveillance, (4) risk assessment, (5) measurement methods, (6) engineering controls and personal protective equipment (PPE), (7) fire and explosion safety, (8) recommendations and guidance, (9) communication and information, and (10) applications. By working in these critical research areas, NIOSH has comprehensively begun to address the information and knowledge gaps necessary to protect workers and responsibly move nanotechnology forward so that its far-reaching benefits may be realized. A summary of research projects may be found in Appendix A. The NIOSH position statement on Nanotechnology –Advancing Research on Occupational Health Implications and Applications is presented in Appendix B. Current intramural NIOSH research activities in nanotechnology are summarized in Appendix C.

Congruent with the efforts of the NTRC are the efforts of the NIOSH Office of Extramural Programs (OEP) which are summarized in Appendix D. OEP uses several mechanisms (R01, R21, R43/44) for funding research. OEP funding of nanotechnology-related research has been undertaken to help increase the knowledge of nanotechnology and engineered nanomaterials as they relate to occupational safety and health. Research areas supported by NIOSH OEP include emission and exposure assessment methods for nanoparticles in the workplace, toxicology of engineered nanomaterials, and the use of nanotechnology for improved workplace monitoring.

NIOSH is working strategically to fill those gaps and others through active intramural and extramural research programs and collaborations (Appendix E). NIOSH is committed to conducting and supporting studies that will improve scientists’ abilities to identify potential occupational health effects of nanomaterials. NIOSH will facilitate the translation of those findings into effective workplace practices.

1.2 NIOSH Logic model

Like other scientific organizations, NIOSH can be described by a model of the way it functions to solve identified problems under various conditions. The overall NIOSH logic model is presented in Figure 1. It has a conventional horseshoe shape with the operational upper branch proceeding from inputs to outcomes and with the strategic lower branch proceeding from strategic goals to management objectives. Both branches are correlated vertically and are subject to external factors.

Figure 1. Schematic of the overall NIOSH logic model.

The NIOSH research program begins with an analysis of production and planning inputs and follows the NIOSH operational model (Figure 2). This analysis determines what can and should be done and thereby identifies research priorities. Intramural and extramural researchers present their project proposals which receive appropriate internal and external review and are funded based on proposal merits. Research activities produce outputs such as published materials, oral presentations, training and educational materials, tools, methods, and technologies. NIOSH research outputs are transferred directly to the final customers and partners (who implement improvements in workplace safety and health) or to intermediate customers (who transform further NIOSH outputs and produce intermediate outcomes). These intermediate outcomes such as pilot technologies, training programs, and regulations and standards are forwarded to the final customers. Since NIOSH is not a regulatory agency, it relies heavily on efforts by intermediate and final customers to achieve ultimate outcomes in the form of workplace safety and health improvements. Effectiveness in achieving these ultimate outcomes is influenced at all stages of program operation by both external factors (such as economic and social conditions) and the regulatory environment. Results of NIOSH-funded research and customer feedback (intermediate and final) contribute to the subsequent rounds of program planning.

Figure 2. Schematic of the NIOSH operational model.