# Protecting the **Nanotechnology Workforce NIOSH Nanotechnology Research and Guidance**  **Strategic Plan, 2013–2016**

D E P AR T M E NT O F HEA L T H AND H U M AN S E R VICE S C e n t e r s f or D is e as e C o n t r o l an d P r e v e n ti o n N a tional I nstitu t e f or O c cup a tional S a f e t y and Health

# Protecting the Nanotechnology Workforce NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013–2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Healthii | Protecting the Nanotechnology Workforce This document is in the public domain and may be freely copied or reprinted. 

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## Suggested Citation NIOSH [2013]. Protecting the nanotechnology workforce: NIOSH nanotechnology research and guidance strategic plan, 2013–2016. Cincinnati, OH: U.S. Department of Health and Human Ser

vices, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2014–106. DHHS (NIOSH) Publication No. 2014–106 December 2013 Safer • Healthier • People TMProtecting the Nanotechnology Workforce | iii 

# Foreword The National Institute for Occupational Safety and Health (NIOSH) is pleased to present Pro

tecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013–2016 . This plan updates the November 2009 strategic plan with knowledge gained from results of ongoing research, as described in the 2012 report Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004–2011. The NIOSH Nanotechnology Research Program follows a comprehensive plan that is managed as a matrix structure across NIOSH and supports multiple sectors in the National Occu

pational Research Agenda (NORA). Nanotechnology provides many opportunities for advancing the economic value and impact of new U.S. technologies and products as it expands into every industrial sector. Today, nanomaterials are found in hundreds of products, ranging from cosmetics, to clothing, to industrial and biomedical applications. The potential benefits of nanotechnology are huge, and these benefits should be re

alized by society. However, there is ongoing concern that the full potential of the societal benefits may not be realized if research efforts are not undertaken to determine how to best manage and control the potential occupational safety and health hazards associated with the handling of these nanomaterials. The research conducted over the past 8 years has proven that NIOSH is a global leader in promot

ing the responsible development of nanotechnology. NIOSH has built business partnerships, estab

lished itself as a key player in nanotoxicology, published precautionary guidance ( Approaches to Safe Nanotechnology: Managing the Safety and Health Concerns Associated with Engineered Nanomaterials ), and issued recommended exposure limits for nanoscale titanium dioxide and for carbon nanotubes and nanofibers. This NIOSH Nanotechnology Research and Guidance Strategic Plan is the roadmap being used to ad

vance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and commercializa

tion of engineered nanomaterials. NIOSH will strive to remain at the forefront of developing guid

ance that supports and promotes the safe and responsible development of such a promising tech

nology.
John Howard, M.D. Director, National Institute for Occupational Safety and Health Centers for Disease Control and Preventioniv | Protecting the Nanotechnology Workforce 

# Executive Summary Nanotechnology—the manipulation of matter on a near-atomic scale to produce new materials and devices—has the ability to transform many industries, from medicine to manufacturing, and the products they produce. By 2020, the National Science Foundation estimates, nanotechnology will have a $3 trillion impact on the global economy and employ 6 million workers in the manufac

ture of nanomaterial-based products, of which 2 million may be manufactured in the United States [NSF 2011]. Nanomaterials may present new challenges to understanding, predicting, and manag

ing potential health risks to workers. Many knowledge gaps still remain on how to work safely with all of these materials. Through stra

tegic planning, research, partnering with stakeholders, and making information widely available, the National Institute for Occupational Safety and Health (NIOSH) is working to continue to provide national and world leadership in providing solutions that will prevent work-related illness and injury. 

## Nanotechnology and NIOSH Research Nanotechnology and the commercialization of products and devices containing engineered nano

materials could help address critical global problems concerning energy, transportation, pollution, health, and food. The potential benefits of nanotechnology are huge, and these benefits should be realized. Nonetheless, there is concern that the full potential of the societal benefits may not be re

alized if cautions about the adverse human health effects are not heeded and concerns are not hon

ored. Timely, targeted research is needed to define hazards, exposures, and risks and to provide guidance for safe handling of nanomaterials. A concerted effort by industry, academia, labor, the professions, and government is needed to identify and address the knowledge gaps in a transpar

ent and credible process that coincides with development of this new technology. NIOSH is play

ing an active part in this process by supporting the development of a broad spectrum of research and prevention strategies for health and safety hazards related to nanotechnology. In a series of re

ports [NIOSH 2007, 2009a, 2012a], NIOSH has summarized its progress in conducting nano

technology research and recommending risk management strategies (see http://www.cdc.gov/niosh/ topics/nanotech/ ). NIOSH investigators have identified adverse health effects in animals exposed to various engineered nanomaterials; assessed exposure of workers; initiated epidemiologic research; and provided guidance on control technologies and medical surveillance. There are many questions still to be answered. A vast number of potential new nanomaterials are possible and could result in a seemingly limitless combination of physicochemical factors. There is need for an expeditious ap

proach to controlling exposure to the large number of nanomaterials in science and commerce now and in the future. Moreover, the advanced nanomaterials under development are likely to have ad

ditional potentially hazardous characteristics that will need to be addressed [Murashov et al. 2012]. 

## NIOSH Nanotechnology Research Center (NTRC) The NIOSH Nanotechnology Research Center (NTRC) was established in 2004 to coordinate nanotechnology research across the institute. Ten critical areas of research were identified, each hav

ing at least one key scientist serving as a coordinator. The NTRC and its steering committee of crit

ical area coordinators are responsible for developing and guiding NIOSH scientific and organiza

tional plans in nanotechnology health and safety research.Protecting the Nanotechnology Workforce | v 

## Strategic Plan The development of nanotechnology has reached a point where it is being widely applied, and nu

merous nanomaterials and nano-enabled products are in commerce. Nanotechnology has the po

tential to provide great benefit to society, but it must be developed responsibly. This responsibili

ty involves addressing any adverse human and environmental impacts of the technology associated with engineered nanomaterials (ENMs). Workers are among the first people in any society to be exposed to the potential health hazards caused by the products of new technology, and their expo

sure to any new material is often greater than for the general population. Therefore, worker safety and health can be seen as the core of responsible development (Figure 1). Through its strategic plan for fiscal years (FY) 2013–2016, NIOSH will marshal its resources and partner with others efficiently and effectively to advance efforts to protect the nanotechnology workforce. With the input of a broad range of stakeholders in government, academia, and the pri

vate sector, NIOSH will continue to operate under a strategic plan for nanotechnology research and guidance. The most recent previous version was published in November 2009 and included research plans through FY 2012 (see http://www.cdc.gov/niosh/docs/2010-105/ ).

Figure 1. The core of responsible development of nanotechnology. 

## Significant benefits to society Responsible development of the technology

Nanomaterial worker safety

and healthvi | Protecting the Nanotechnology Workforce This document presents the NTRC Strategic Plan for FY2013–FY2016. The strategic plan also highlights how the critical research and guidance efforts of NIOSH align with and support the comprehensive Environmental, Health, and Safety Research Strategy needs of the National Nan

otechnology Initiative. For the period FY2013–FY2016, NIOSH will continue to fill information and knowledge gaps that address the five NIOSH NTRC strategic goals:

1. Increase understanding of new hazards and related health risks to nanomaterial workers. 2. Expand understanding of the initial hazard findings of engineered nanomaterials. 3. Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches. 4. Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies. 5. Assess and promote national and international adherence with risk management guidance. To address these strategic goals and promote the responsible development of engineered nanoma

terials, the strategic plan will expand research activities in 10 NTRC critical areas: toxicity and in

ternal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk as

sessment; engineering controls and personal protective equipment (PPE); fire and explosion safety; recommendations and guidance; global collaborations; and applications.Protecting the Nanotechnology Workforce | vii 

# Contents Foreword
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Executive Summary
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv Acknowledgments
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix Abbreviations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x 

## 1 INTRODUCTION 1

1.1 Background
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 Mission of NIOSH
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.3 NIOSH Logic Model
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 

## 2 INPUTS 7

2.1 Nature of Nanomaterials
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2 Nature of the Nanomaterial Workplace
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.3 Customer and Stakeholder Input
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.4 NIOSH Research Capabilities
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.5 NIOSH Partnerships
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 

## 3 ACTIVITIES 11 3.1 NIOSH Nanotechnology Research Center (NTRC)
. . . . . . . . . . . . . . . . . . . . . . . . . 11 3.2 NTRC Steering Committee
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.3 Current NIOSH NTRC Intramural Nanotechnology Research Activities
. . . . . . . . 11 3.3.1 Evaluation of the nanotechnology research program
. . . . . . . . . . . . . . . . . . . . 11 3.4 Current NIOSH Extramural Nanotechnology Research Activities
. . . . . . . . . . . . . . 12 

## 4 GOALS 13

4.1 Address Each Element in the Risk Management Continuum
. . . . . . . . . . . . . . . . . 13 4.2 Identification of NTRC Data Needs for Knowledge Gaps
. . . . . . . . . . . . . . . . . . . . 13 4.3 Coalescing Priorities for NIOSH NTRC Research and Guidance for FY2013–FY2016
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 4.4 Coordination with the National Nanotechnology Initiative
. . . . . . . . . . . . . . . . . . . . 18 4.5 Proposed NIOSH NTRC Research
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

## 5 OUTPUTS 29

5.1 NIOSH Publications on Nanotechnology Since 2009
. . . . . . . . . . . . . . . . . . . . . . . . 29 5.2 NIOSH Peer-Reviewed Publications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 5.3 Sponsored Conferences
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 5.4 Presentations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30viii | Protecting the Nanotechnology Workforce 

## 6 RESEARCH TO PRACTICE (r2p) 31 6.1 Capacity Building through Technical Assistance
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 

## 7 Intermediate Customers and Intermediate Outcomes 33 7.1 Federal Government Agencies
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7.2 Standards Development Organizations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7.3 Industry, Labor, and Academia
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7.4 Professional Organizations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7.5 Research Collaborations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 7.6 International Activities
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 

## 8 OUTCOMES 35
References
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Appendix A: Comprehensive Chart of the NNI 2011 EHS Research Needs
. . . . . . . . . . . . . . 39 Appendix B: Timeline for NIOSH Nanotechnology Research
. . . . . . . . . . . . . . . . . . . . . . . . . 49Protecting the Nanotechnology Workforce | ix 

# Acknowledgments This report was developed by the scientists and staff of the National Institute for Occupation

al Safety and Health (NIOSH) who participate in the NIOSH Nanotechnology Research Cen

ter (NTRC). Paul Schulte is the manager and Charles Geraci is the coordinator of the NIOSH cross-sector program. Special thanks go to Laura Hodson for writing and organizing the report. Others who contributed substantially to the report include Vincent Castranova, Teh-hsun (Bean) Chen, Matthew Dahm, Kevin Dunn, Douglas Evans, Pengfei Gao, Mark Hoover, Eileen Kuempel, Kenneth Martinez, Vladimir Murashov, Mary Schubauer-Berigan, Aleksandr Stefaniak, Douglas Trout, and Leonid Turkevich. The NIOSH NTRC acknowledges the contributions of Sarah Earl, Gino Fazio, Rachel Thieman, and Vanessa Williams for their graphic design and production services, and Seleen Collins for ed

iting the report. In addition, it expresses special appreciation to these individuals and organizations for their reviews and comments: Carol Rice, Ph.D., CIH University of Cincinnati Cincinnati, OH Michael Kosnett, M.D. University of Colorado Denver, CO James Bonner, Ph.D. North Carolina State University Raleigh, NC Lindsey Darrow, Ph.D. Rollins School of Public Health Atlanta, GA Ellen Eisen, Ph.D. University of California, Berkeley Berkeley, CA Michael Ellenbecker, Ph.D. University of Massachusetts, Lowell Lowell, MA Lawrence Gibbs, M.Ed., M.P.H., CIH Stanford University Stanford, CA Steven Gordon, Ph.D. 3M St. Paul, MN Bruce Lippy, Ph.D., CIH, CSP CPWR, The Center for Construction Research and Training Baltimore, MD Günter Oberdörster, D.V.M., Ph.D. University of Rochester Medical Center Rochester, NY Michele Ostraat, Ph.D. RTI International Research Triangle Park, NC Gurumurthy Ramachandran, Ph.D. University of Minnesota Minneapolis, MN Darius Sivin, Ph.D. United Auto Workers Washington, D.C.x | Protecting the Nanotechnology Workforce 

# Abbreviations AFL-CIO American Federation of Labor and Congress of Industrial Organizations AIHA American Industrial Hygiene Association ANSES The French Agency for Food, Environmental and Occupational Health and Safety ANSI American National Standards Institute ASSE American Society of Safety Engineers ASTM American Society for Testing and Materials (currently ASTM International) CNT carbon nanotube CPSC Consumer Product Safety Commission DHHS Department of Health and Human Services DOT Department of Transportation EHS environment, health and safety ENM engineered nanomaterial EPA U.S. Environmental Protection Agency EU European Union FMSH Federal Mine Safety and Health FY fiscal year ICOH International Commission on Occupational Health ICON International Council on Nanotechnology IEC International Electrotechnical Commission ILO International Labour Organization ISEA International Safety Equipment Association ISO International Organization for Standardization MSHA Mine Safety and Health Administration NanoBCA Nanobusiness Commercialization Association NCER National Center for Environmental Research NEHI Nanotechnology Environmental and Health Implications NFPA National Fire Protection Association NIEHS National Institute of Environmental Health Sciences NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health NIST National Institute of Standards and Technology NNI National Nanotechnology Initiative NORA National Occupational Research AgendaProtecting the Nanotechnology Workforce | xi NSC National Safety Council NSF National Science Foundation NTRC Nanotechnology Research Center OECD Organization for Economic Cooperation and Development OEP Office of Extramural Programs OSH occupational safety and health OSHA Occupational Safety and Health Administration PPE personal protective equipment PtD Prevention through Design r2p Research to Practice TNO The Netherlands Organization for Applied Scientific Research UN United Nations WHO World Health OrganizationProtecting the Nanotechnology Workforce | 1 

# 1 INTRODUCTION

1.1 Background Nanotechnology is a system of innovative meth

ods to control and manipulate matter at nearatomic scale to produce new materials, structures, and devices. Nano-objects are nanomaterials that have at least one dimension less than 100 nano

meters [ISO 2008]. Nanoparticles are a specific class or subset of these nano-objects, having three dimensions that are less than 100 nanometers. Nanoparticles exhibit unique properties because of their nanoscale dimensions. Nanotechnolo

gy offers the potential for tremendous improve

ment and advances in the development of com

mercial products that may benefit society, such as integrated sensors, semiconductors, medical imaging, drug delivery systems, structural mate

rials, sunscreens, cosmetics, and coatings. Nano

technology is one of the most enabling technolo

gies across the world. By 2020, the global market for nanotechnology-related products is predicted to reach $3 trillion and employ 2 million work

ers in the United States alone [NSF 2011]. A review of the 2013 version of the Nanowerk nanomaterials database ( http://www.nanowerk. com/phpscripts/n_dbsearch.php ) revealed more than 3,000 commercially available nanomaterials. However, the properties of engineered nanopar

ticles (e.g., size, surface area, reactivity) that yield many improvements in commercial products may also pose health risks. Increasing numbers of workers are potentially exposed to nanoma

terials in research laboratories, start-up compa

nies, production facilities, and operations where nanomaterials are processed, used, disposed, or recycled. The challenge is to determine wheth

er the nature of intentionally produced (engi

neered) nanostructured materials and devic

es presents new occupational safety and health risks. At the same time, there is a need to ad

dress how the benefits of nanotechnology can be realized while the risks are proactively min

imized. Efforts across multiple federal agencies and the private and academic sectors are fostering the development and use of nanotechnology. In 2001, the President’s Council of Advisors on Science and Technology collaborated with the interagency National Science and Technology Council to create the National Nanotechnol

ogy Initiative (NNI) [NNI 2001]. This initia

tive supports basic and applied research in nan

otechnology to create new nanomaterials and to disseminate new technical capabilities to indus

try. The purpose of the NNI is to facilitate sci

entific breakthroughs and maintain U.S. com

petitiveness in nanoscience. A stated goal of this interagency program is to ensure that nanotech

nology research leads to the responsible devel

opment of beneficial applications by giving high priority to research on human health, environ

mental issues, and societal implications related to nanotechnology. 

## 1.2 Mission of NIOSH In the Occupational Safety and Health Act of 1970 (OSH Act, Public Law 91-596) and the Federal Mine Safety and Health Act of 1977 (FMSH Act, Public Law 95-164), Congress de

clared that the intent of these acts was to ensure, insofar as possible, safe and healthful working conditions for every working man and woman, to preserve our human resources. In these acts, NIOSH is given the responsibility for recom

mending occupational safety and health stan

dards and defining exposure levels that are safe for various periods of employment. These in

clude (but are not limited to) the exposures at which no worker will suffer diminished health, functional capacity, or life expectancy as a result2 | Protecting the Nanotechnology Workforce of his or her work experience. By means of crite

ria documents and other publications, NIOSH communicates these recommended standards to the Occupational Safety and Health Admin

istration (OSHA), the Mine Safety and Health Administration (MSHA), and others in the oc

cupational safety and health community. Under the OSH Act, NIOSH is charged with conducting “research, experiments, and dem

onstrations relating to occupational safety and health” and with developing “innovative meth

ods, techniques, and approaches for dealing with [those] problems.” The act specifies target areas of research that include identifying crite

ria for setting worker exposure standards and exploring problems created by new technology in the workplace. In an amendment to the act, NIOSH was given responsibility for conduct

ing training and education “to provide an ade

quate supply of qualified personnel to carry out the purposes of the Act” and for assisting em

ployers and workers with applying methods to prevent occupational injuries and illness (Sec

tion 21 of the OSH Act). NIOSH has over 40 years of experience in con

ducting research and formulating recommen

dations for occupational safety and health. During this period, NIOSH has developed considerable expertise in measuring, character

izing, and evaluating new processes and new materials by conducting quantitative expo

sure assessments and evaluating health effects. NIOSH also has expertise in developing expo

sure control systems and prevention strategies as well as experience in conducting risk assess

ments and recommending effective risk man

agement practices. In 2003, NIOSH became a member of the Na

noscale Science, Engineering, and Technology (NSET) Subcommittee of the National Sci

ence and Technology Council. As a member, NIOSH participates in (1) identifying critical issues related to possible hazards of nanoma

terials, (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. 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 dis

seminate information gained. The NTRC com

prises nanotechnology-related activities and projects supported by approximately 50 sci

entists in various NIOSH divisions and lab

oratories. Through the NTRC, NIOSH has identified 10 critical research areas for nano

technology research and communication. These 10 critical research areas, updated for FY2013– FY2016, are toxicity and internal dose; mea

surement methods; exposure assessment; ep

idemiology and surveillance; risk assessment; engineering controls and personal protec

tive equipment (PPE); fire and explosion safe

ty; recommendations and guidance; global col

laborations; and applications. By conducting a complete plan of research in these critical areas in a coordinated, concurrent manner, NIOSH is comprehensively addressing the information and knowledge gaps necessary to protect work

ers and responsibly move nanotechnology for

ward so that its far-reaching benefits may be re

alized. The NIOSH NTRC is working strategical

ly to fill nanomaterial occupational safety and health knowledge gaps through active intra

mural and extramural research programs and collaborations. Extramural research is carried out through the NIOSH Office of Extramu

ral Programs (OEP), in which nanotechnolo

gy research (through R01, K01, R03, R21, and R43/44 grant mechanisms) is funded to in

crease the knowledge of nanotechnology and engineered nanomaterials (ENMs) as they re

late to occupational safety and health. Research areas supported by the NIOSH OEP include emission and exposure assessment methods for nanoparticles in the workplace, toxicology of ENMs, and use of nanotechnology for the development of sensors. NIOSH is committedProtecting the Nanotechnology Workforce | 3 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. NIOSH reported on the progress of the NTRC in Filling the Knowledge Gaps for Safe Nano

technology in the Workplace (Figure 2). This re

port presents the program accomplishments of the NTRC from its inception in 2004 through 2011. The NIOSH NTRC continues to be part of the U.S. leadership on the International Organiza

tion for Standardization (ISO) TC 229 Nano

technology Working Group on Health, Safe

ty, and the Environment and continues to work with the World Health Organization (WHO) collaborating centers on global projects of in

formation dissemination and communication. Through these collaborations, the NIOSH NTRC assists in developing risk communica

tions on the safe handling of nanomaterials. 

## 1.3 NIOSH Logic Model NIOSH receives input on identifying and ad

dressing occupational safety and health prob

lems through a logic model (i.e., a process) in which the seriousness of the problem or haz

ard is evaluated, the type and level of research needed are determined, and a plan and process for communicating the research outcomes are formulated. The overall NIOSH logic model (Figure 3) has a conventional horseshoe shape, with the operational upper branch proceeding from inputs to mission relevant outcomes and the strategic lower branch supporting those op

erations through a process of measurable goals and management objectives. The two branches are correlated and are subject to external factors. The NIOSH operational model (Figure 4) for conducting research adheres to the logic mod

el in the acquisition and analysis of inputs from customers/stakeholders ( production inputs ) and internal/external research capabilities ( planning inputs ) to determine and prioritize research.

Figure 2. The cover of DHHS (NIOSH) Publication No. 2013–101, the progress report of the NTRC.4 | Protecting the Nanotechnology Workforce Intramural and extramural researchers present their project proposals, which receive appropri

ate internal and external review and are funded on the basis of merit. The conduct of research ( activities) produces “outputs” such as guid

ance documents and reports that address ef

fective risk management practices, worker and employer education, and new technologies for assessing and controlling workplace hazards. NIOSH outputs are transferred directly to the final customers and stakeholders (who imple

ment improvements in workplace safety and health) or to intermediate customers (who uti

lize NIOSH outputs to produce intermediate outcomes ). These intermediate outcomes, such

Figure 3. Schematic of the overall NIOSH logic model. as training programs, regulations, and occupa

tional standards, are used to advance workplace safety and health. Since NIOSH is not a regu

latory agency, it relies heavily on efforts by in

termediate and final customers to achieve ulti

mate outcomes in the form of workplace safety and health improvements. The effectiveness in achieving these outcomes is influenced at all stages of the program operation by both exter

nal factors (such as economic and social con

ditions) and the regulatory environment. Re

sults of NIOSH-funded research and customer feedback ( intermediate and final outcomes ) con

tribute to the subsequent rounds of program planning.

Inputs Activities Outputs Customers

Management

Objectives Annual Goals

External factors Intermediate Goals Strategic Goals Outcomes Operations

Strategy and design MissionProtecting the Nanotechnology Workforce | 5Figure 4. Schematic of the NIOSH operational model.Research*:Surveillance,epidemiologicaland behavioralstudies,interventionstudies, laboratoryand field studies,exposure andmeasurements andrisk assessment,control studiesand development,PPE studies anddevelopment*intramural andextramural, includingdomestic andinternational efforts,such as workconducted at ERCs,AFCs, and WHOGlobal Network ofCollaborating CentersMission:To Provide National andWorld Leadership to PreventWork-Related Illness and InjuriesEndOutcomesProductionInputs:budget, staff,facilities,managerial,infrastructurePlanningInputs:customer/stakeholderinputs,surveillanceandinterventioneffectivenessdata, HHEs,earmarks, riskassessmentsOSHA,MSHA,otherfederalagencies;NIOSHprograms;Congress;stateandlocalagencies;standardsbodies; labor,tradeandprofessionalassociations;technologydevelopersandmanufacturers;otherresearchers;S&HpractitionersEmployees,employers,industry,educators,regulatorswhoreduceor preventhazardousexposures orconditionsImprovementsin safety andhealth inworkplacesPilot and/ormarketreadytechnologies,training andeducationprograms,guidance,regulations,standards,trade and majormediareleases;websitesTransfer:•Translation ofresearch intopractice, productsand technologies•Informationdissemination•Capacity buildingthrough technicalassistance(HHEs), trainingand education•Recommendations,reports,publications,workshops,databases,conferences•Training andeducation materialsand demonstrationprograms, trainedprofessionals•Tools and methods,best practices,developmentaltechnologies,licenses, patentsExternal Factors:Economic and socialconditions andregulatorenvoronmentConduct surveillance and evaluate intervention effectivenessResearch PartnersFeedbackTransferInputsActivitiesOutputsIntermediate OutcomesProtecting the Nanotechnology Workforce | 7 

# 2 INPUTS

2.1 Nature of Nanomaterials The universe of nanomaterials is potentially large because of the array of possible combina

tions of physicochemical parameters, impurities, and manufacturing and production conditions (Figure 5). NIOSH recognizes the extensive di

versity and number of nanomaterials and the even larger number of applications for those materials. Consequently, it continues to use ap

proaches that allow for a holistic view of nano

materials and development of priorities that will be beneficial to many workers. 

## 2.2 Nature of the Nanomaterial Workplace Worker exposure to nanomaterials may occur along the life cycle of the nanomaterial, from re

search through scale-up, manufacturing, prod

uct development, use, and end of life (Figure 6). Each of the functional areas represents work

places with different potential exposure scenar

ios and risks. NIOSH continues to focus on the wide array of workplaces where exposure to nanomaterials may occur. 

## 2.3 Customer and Stakeholder Input To direct its research and fulfill its responsi

bilities under the OSH Act and the FMSH Act, NIOSH has relied on input from OSHA and MSHA, workers, employers, trade associ

ations, unions, occupational safety and health practitioners and researchers, and the general public. NIOSH also seeks input through for

mal committees, such as the NIOSH Board of Scientific Counselors, the National Advi

sory Committee on Occupational Safety and Health, and the Mine Safety and Health Re

search Advisory Committee. It also receives

Figure 5. The wide variety of physicochemical parameters of engineered nanomaterials [Schulte et al. 2009].8 | Protecting the Nanotechnology Workforce Figure 6. The life cycle of nanomaterials [Schulte et al. 2008a]. 

### Research Laboratories

Start-Up/Scale-Up Operations

Manufacturing/Production

Incorporation in Products

Recycling Warehousing/Maintenance Waste Handling

Transport Warehousing/Maintenace

Warehousing/Maintenance Transport Waste handling

Maintenance of Products Manipulation of Products Application of Products-Medical Delivery 

### Disposal/End of LifeProtecting the Nanotechnology Workforce | 9 input through ad hoc mechanisms such as the NIOSH Web site ( www.cdc.gov/niosh) , a tollfree telephone line (1-800-CDC-INFO), per

sonal contacts with occupational safety and health professionals, and participation in pro

fessional conferences and interagency commit

tees. In addition, NIOSH provides stewardship of the National Occupational Research Agen

da (NORA) ( http://www.cdc.gov/niosh/nora), which is a framework to guide occupational safety and health research into the new millen

nium—not only for NIOSH but for the entire occupational safety and health community. NIOSH continues to be a participating and partnering agency in the National Nanotech

nology Initiative (NNI) and provides occu

pational health and safety expertise in sup

port of the U.S. Government’s Strategic Plan for Nanotechnology Environmental, Health, and Safety Research [NNI 2011]. NIOSH is co-leader of the NNI Nanotechnology En

vironmental and Health Implications Work

ing Group (NEHI) and contributed to the de

velopment of the 2011 NEHI Environmental, Health, and Safety (EHS) Research Strategy. The 2011 NEHI EHS research strategy iden

tified five core nanotechnology EHS research categories: (1) nanomaterial measurement in

frastructure, (2) human exposure assessment, (3) human health, (4) environment, and (5) risk as

sessment and management methods (Appendix A) [NNI 2011]. NIOSH provided significant input for the strategy and was the lead agen

cy for developing recommendations on human exposure assessment. The NNI EHS research strategy focuses on the use of science-based risk analysis and risk management to protect public health and the environment while fostering the technological advancements that benefit soci

ety. NIOSH has strived to keep the overarching research activities of the NTRC nanotechnol

ogy strategic plan (Section 4.3) consistent with the NNI EHS research strategy. The NIOSH NTRC also fosters stakeholder in

put with trade associations, professional associ

ations, labor, nongovernmental organizations, and a number of private nanomaterial compa

nies. These collaborations have provided exper

tise and resources critical for reviewing research activities and for developing and disseminating health and safety information on engineered nanoparticles. Some of the ongoing NTRC stakeholders are the American Industrial Hy

giene Association (AIHA), American Soci

ety of Safety Engineers (ASSE), International Safety Equipment Association (ISEA), Na

tional Safety Council (NSC), American Feder

ation of Labor and Congress of Industrial Or

ganizations (AFL–CIO), and NanoBusiness Commercialization Association (NanoBCA). 

## 2.4 NIOSH Research Capabilities Within its divisions, NIOSH has world-re

nowned researchers who are trained and expe

rienced in the full spectrum of scientific skills needed to evaluate and characterize workplace hazards and devise intervention strategies for protecting workers. In addition to this exper

tise, NIOSH has significant laboratory capa

bilities in particle measurement, aerosol col

lection and characterization, particle surface analysis, measurement of particle surface rad

icals and activity, and in vitro and in vivo anal

ysis of toxicity and pathogenesis. Laboratories conducting nanomaterial research are locat

ed in Cincinnati, Ohio; Pittsburgh, Pennsylva

nia; and Morgantown, West Virginia. NIOSH researchers work closely with a broad range of scientists from industry, academia, and oth

er government agencies. The involvement of NIOSH in national and international initia

tives and programs is an important component of its capacity to address critical occupational safety and health issues in nanotechnology. 

## 2.5 NIOSH Partnerships NIOSH recognizes both the practical need and the leadership obligation to extend its internal capabilities by leveraging activities and expertise found in other research institutions, industries,10 | Protecting the Nanotechnology Workforce federal agencies, and nongovernmental organi

zations. These partnerships serve to deliver on multiple objectives; most important, they add to the body of knowledge on workplace health and safety issues associated with nanotechnolo

gy. Partnerships have taken several forms, rang

ing from formal letters or memoranda of un

derstanding to informal working agreements on a specific topic. NIOSH will continue to pursue partnerships as a means of achieving the goals of this strategic research plan and as ef

fective vehicles to develop and disseminate re

search results. The NIOSH NTRC has successfully used part

nerships with industry to gain a better under

standing of actual industrial nanomaterial pro

cesses, workplace exposures, work practices, and exposure control techniques. The field research conducted by the NTRC to assess exposures to engineered nanoparticles represents ongoing part

nerships with numerous companies. The NTRC will continue to develop these partnerships to
• better understand how engineered nanoparticles are being produced and used • develop recommendations for the safe handling of nanomaterials • develop sampling and analytical methods • evaluate exposure controls that are or could be used in nanomaterial processes • evaluate the need for and determine the effectiveness of PPE, including respira

tory protection • develop communication and informa

tion materials that will assist industry in communicating with workers and the public. Several of the industrial partnerships have pro

vided opportunities for the NTRC to identi

fy areas in which additional research is needed. The continued collaboration with other na

tional and international research institutes, ac

ademia, and government agencies provides the NTRC the opportunity to combine its exper

tise in workplace health and safety with the capabilities of other organizations to investi

gate specific areas of concern. Working rela

tionships with other research institutes pro

vide the NTRC with the information needed to guide its own research, focus its limited re

sources effectively, and expand its research ca

pabilities through scientific collaboration. The NTRC has developed partnerships in the ar

eas of toxicology, risk assessment modeling, ex

posure measurement methods, epidemiology, industrial hygiene, control technologies, filtra

tion of nanoparticles, and communication of research results and safe work practices. The NTRC has broadened its activities with collaborators and stakeholders by participating in a number of national and international com

mittees and working groups. This participation provides NTRC scientists the opportunity to provide and receive input on the key research that is needed to address priority areas.Protecting the Nanotechnology Workforce | 11 

# 3 ACTIVITIES

3.1 NIOSH Nanotechnology Research Center (NTRC) Vision of the NTRC The vision of the NTRC is as follows: Safe nanotechnology by delivering on the Na

tion’s promise—safety and health at work for all people through research and prevention. 

### Mission of the NTRC The mission of the NTRC is to provide nation

al and world leadership for research and guid

ance on the implications of nanoparticles and nanomaterials for work-related injury and ill

ness, and the application of nanoparticles and nanomaterials in occupational safety and health. 

## 3.2 NTRC Steering Committee The NTRC Steering Committee is chaired by the NTRC Coordinator. The committee is made up of the program manager, program coordina

tor, program assistant coordinator, and critical area coordinators for each of the 10 research areas (some areas have multiple research coordinators). The steering committee is responsible for guid

ing NIOSH scientific and organizational plans in nanotechnology research (including coordina

tion for science and budget) and for developing strategic goals and objectives and performance measures for the NTRC. Regular updates and progress reports on internal research activities are managed through biweekly teleconferences among members of the NTRC Steering Com

mittee. In addition, to ensure the responsiveness, relevance, and impact of the NIOSH nanotech

nology program, members of the NTRC and ap

propriate stakeholders meet in person every 2 years at a scientific exchange meeting. 

## 3.3 Current NIOSH NTRC Intramural Nanotechnology Research Activities Current NIOSH NTRC research activities in nanotechnology are focused on occupational safety and health implications and applications of ENMs. Data gathered from ongoing research studies with engineered nanoparticles are used to better understand workplace nanoparticle ex

posures, the hazards posed by nanomaterials, and the potential risk of adverse health effects from occupational exposures. Studies are also providing data on the characteristics of nano

materials produced and used in the workplace, routes of exposure, and the effectiveness of work practices and engineering controls in prevent

ing worker exposure. Findings from these in

tramural studies are providing scientific data to support the development of occupational safe

ty and health recommendations. NIOSH prog

ress and accomplishments in nanotechnology research can be found in the report Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace [NIOSH 2012a]. 

### 3.3.1 Evaluation of the nanotechnology research program NIOSH evaluates its research progress in nan

otechnology through a series of internal and external reviews. Past reviews of its nanotech

nology research program have been conduct

ed by the National Academies and by a work

group of scientists chaired by two members of the NIOSH Board of Scientific Counselors. Based on these reviews, a revised strategic plan was published in November 2009 that proposed focused research and guidance on (1) identi

fying categories of nanomaterials that can be distinguished by their physical and chemical12 | Protecting the Nanotechnology Workforce properties; (2) recommending specific expo

sure limits for various nanomaterials; (3) assess

ing hazards, risks, and exposures; and (4) devel

oping intervention strategies [NIOSH 2009b]. In addition to external reviews, NIOSH con

tinues to conduct annual program reviews and regular project reviews, and it publishes period

ic progress reports describing ongoing research and accomplishments. This NIOSH Nanotechnology Research and Guidance Strategic Plan was reviewed by a workgroup of scientists chaired by two members of the NIOSH Board of Scientific Counselors, and public comment was solicited through an announcement in the Federal Register. 

## 3.4 Current NIOSH Extramural Nanotechnology Research Activities The NIOSH Office of Extramural Pro

grams (OEP) manages the competitive pro

cess for awarding occupational safety and health grants and cooperative agreements to the research community outside the Insti

tute. This process involves peer review, pro

gram relevance, and priorities of the Nation

al Occupational Research Agenda (NORA), the NIOSH Research to Practice (r2p) ini

tiative, congressional mandates, and sector, cross-sector, or coordinated emphasis areas of the NIOSH Program Portfolio ( http://www. cdc.gov/niosh/programs ). Since 2001, the NIOSH OEP has fund

ed nanotechnology research through Occupa

tional Safety and Health Research Program Announcements (R01), Mentored Scientist Grants (K01), Small Research Grants (R03), Developmental Grants (R21), and Small Busi

ness Innovation Research Grants (R43/44). During the period 2001 to 2012, the NIOSH OEP has committed approximately $12 million to extramural nanotechnology research. * Sum

maries of the projects funded by the NIOSH OEP are included in the document Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace [NIOSH 2012a]. Through con

tinued collaboration with the Environmental Protection Agency/National Center for Envi

ronmental Research (EPA/NCER), National Science Foundation (NSF), National Institutes of Health/National Institute of Environmental Health Sciences (NIH/NIEHS), and interna

tional agencies, the NIOSH OEP continues to support nanotechnology research that focuses on occupational safety and health issues. In ad

dition, the NIOSH OEP routinely confers with the NIOSH NTRC regarding research needs. *This includes all extramural projects that involve any as

pect of nanotechnology.Protecting the Nanotechnology Workforce | 13 

# 4 GOALS

4.1 Address Each Element in the Risk Management Continuum Ultimately, the goal of the NTRC is to develop information, knowledge, and guidance to pro

tect the nanotechnology workforce. It is rela

tively early in the emergence of nanotechnolo

gy and there are many gaps in knowledge, yet nano-enabled products are in commerce and workers are being exposed to nanomaterials. Consequently, there is a need to address all ele

ments in the risk management continuum con

currently. The process for managing potential workplace exposures to engineered nanoparticles during their synthesis, manufacture, and incorporation into new materials and devices consists of the following steps to ascertain the appropriate risk management strategy:

1. identifying and characterizing the health and safety hazard; 2. conducting dose-response risk assess

ment; 3. assessing the extent of exposure; 4. characterizing the risk on the basis of exposure; and 5. developing control and management procedures [Schulte et al. 2008b]. As exposure assessment data for nanomateri

als become available, the existence of any occu

pational risk—and the conditions under which exposure to the hazard would be harmful to workers—can be determined. A goal of the risk characterization is to determine whether expo

sure to a type of material (in this case, nanoma

terials) used in a given technology is likely to result in adverse health effects. Exposure assess

ment data provide a means to determine wheth

er workers might be exposed and what type of control strategy might be effective in prevent

ing exposure. Epidemiologic research is need

ed to provide etiologic evidence for new hazards and quantitative exposure–response informa

tion for recommended exposure limits. Deci

sions about which nanomaterials to study ep

idemiologically require collecting information on workforce size, exposure levels, and expect

ed hazard (from toxicological or other informa

tion). The NIOSH NTRC is involved in con

ducting research and answering questions posed in each element of the risk management process to address knowledge gaps in the protection of workers (Figure 7). A challenge of the NIOSH NTRC program is to determine how to conduct timely research that addresses the elements of hazard identifi

cation through risk management, as introduc

tion of nanomaterials to the workplace contin

ues and the workforce exposed to them becomes more diversified. The approach taken by the NTRC has been to conduct concurrent, focused research to address knowledge gaps in each step of the risk management process to provide oc

cupational safety and health guidance. 

## 4.2 Identification of NTRC Data Needs for Knowledge Gaps In preparing this strategic plan, the NTRC steering committee met in spring 2012 to iden

tify data needs and research gaps. Information was gleaned from various sources:
• research studies conducted by the NIOSH NTRC and others • comments received during public review from open meetings or submitted to the NIOSH Docket on Interim Guidance for14 | Protecting the Nanotechnology Workforce 

### Hazard Identification “ Is there reason to believe

this could be harmful?”

Risk Management “Develop procedures to

minimize exposures”. Hazard Characterization “ H ow and under what conditions could it be harmful?”

Exposure Assessment “Will there be exposure in

real-world conditions?”

Risk Characterization “ I s substance hazardous an d w ill there be exposure?” • Toxicologic research • Health effects assessment • Safety research

• Toxicologic research • Field assessment • Epidemiologic and hazard

surveillance research

• Metrology research • Field assessment • Control technology research • Personal protective equipment

(PPE) research

• Risk assessment • Dose-response modeling • Exposure characterization • Epidemiologic research

• Risk communication • Guidance development for

controls, exposure limits , PPE, and medical surveillance • Information dissemination • Adherence investigation 

## Gaps in the Protection of Workers 

## NIOSH Focus

A d a p t e d f r o m G i b b s [ 2 0 0 6] and NRC [2009].

Figure 7. Addressing knowledge gaps in protecting nanomaterial workers.Protecting the Nanotechnology Workforce | 15 Medical Screening and Hazard Surveil

lance for Workers Potentially Exposed to Engineered Nanoparticles • comments received during public review from open meetings or submitted to the NIOSH Docket on Current Intelligence Bulletin for Occupational Exposure to Car

bon Nanotubes and Nanofibers • comments received in the NIOSH Dock

et on the draft strategic goals [76 Fed. Reg. * 123612]
• the 2011 NEHI Environmental, Health, and Safety (EHS) Research Strategy
• various scientific meetings and collabo

rations, including tripartite attendance (labor, industry, and government) and stakeholder input workshops. On the basis of this information, the following data needs and research gaps have been identified. Increase understanding of new hazards and re
lated health risks to nanomaterial workers
• Identify emerging commercial ENMs through market forecasting and research, technology surveillance, and partner and stakeholder input. • Determine how workers might be ex

posed to nanoparticles during manufac

turing, handling, and use of nanomaterials.

— Expand research from primary manufacturer to second-, third-, and fourth-generation use of ENMs.

— Continue field investigations to bet

ter understand worker exposures throughout the life cycle, including processing of nano-enabled products.

— Determine how ENMs interact with the body’s systems.

— Determine relationships between specific physicochemical properties of ENMs and adverse biological effects. *Federal Register. Expand understanding of the initial hazard findings of engineered nanomaterials
• Determine carcinogenicity of carbon nano

tubes (CNTs). • Determine whether the cardiovascular sys

tem is more sensitive than the lungs to ef

fects from ENM exposures. • Determine whether ENMs cause im

mune dysfunction. • Explore the usefulness of biomarkers for identifying and determining the extent of worker exposure and the potential for adverse health effects. • Conduct research on measurement meth

ods for nanomaterials.

— Align laboratory and field exposure metrics and measurement techniques.

— Expand and refine workplace mea

surement techniques for assessing exposure (tiered approach).

— Develop a microscopy method for CNTs and other ENMs.

— Identify the critical reference materi

als needed for measurement. • Continue to evaluate additional ENMs for dustiness, explosibility, flammability, and electromagnetic hazard potential.

— Correlate dustiness, explosion, fire, and electromagnetic data with exist

ing hazard indexes. Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about the hazards, risk, and risk management approaches.
• Develop categorical and specific occupa

tional exposure limits.

— Conduct research to recommend specific exposure limits for various ENMs (e.g., nanosilver, graphene, carbon black, nano silica, nanoceram

ics, nano clays, nano catalysts), and16 | Protecting the Nanotechnology Workforce evaluate the adequacy of existing ex

posure limits. • Identify categories of nanomaterials that can be distinguished by physicochemical parameters. • Conduct risk assessments.

— Nanoparticle lung dosimetry mod

eling

— Categorization and comparative po

tency methods • Link risk assessment, toxicology, expo

sure measurement, and control strategies. • Demonstrate effective risk management practices. • Develop guidance materials.

— Update guidance for medical surveil

lance (include sensitivity and speci

ficity of medical tests).

— Evaluate and provide guidance on control technology.

— Integrate Prevention through Design (PtD) into ENM risk management guidelines.

— Use categorical approaches for ENMs to develop guidance on controlling exposures (hazard and control band

ing).

— Evaluate and provide guidance on PPE for use with ENMs. • Partner with businesses to promote safe and responsible handling of ENMs. • Determine whether there are potential ap

plications of nanomaterials for safety and health (e.g., improved sensors or PPE). Support epidemiologic studies for nanomate
rial workers, including medical, cross-section
al, prospective cohort and exposure studies.
• Conduct epidemiologic research on the health of nanomaterial workers by em

ploying both cross-sectional and pro

spective designs. • Partner with other U.S. agencies and groups that have begun epidemiologic and other surveillance studies. • Determine appropriate tools for medi

cal screening and mechanisms of medical surveillance among workers exposed to specific EMNs. • Create an exposure database that harmo

nizes with global exposure databases. Assess and promote national and internation
al adherence with risk management guidance
• Conduct a national assessment to de

termine the extent of use of nanomate

rial exposure controls and any barriers to their use. • Provide intervention strategies for indus

try sectors where adherence to good riskmanagement practices is low. • Partner with other businesses, U.S. agen

cies, and the international community to promote safe, responsible development of nanomaterials. 

## 4.3 Coalescing Priorities for NIOSH NTRC Research and Guidance for FY2013–FY2016 The NIOSH NTRC has proposed specific re

search activities (see Section 4.5) for FY2013– FY2016 that address the previously identified research needs and gaps (Section 4.2). Figure 8 provides a schema for how NIOSH will fo

cus its research activities in accordance with the goals of the NTRC Strategic Plan:
• Increase understanding of new hazards and related health risks to nanomaterial workers. • Expand understanding of the initial haz

ard findings of engineered nanomaterials. • Support the creation of standards and guid

ance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makersProtecting the Nanotechnology Workforce | 17Figure 8. Focus of NIOSH nanomaterial research, 2013–2016.Critical next sepsAssess national and internationaladherence to guidelinesDevelop andupdate guidanceClarify initialhazard findingsIdentify newhazardsConductepidemiologic studiesInformaticsControl technologyand PPERiskassessmentMedicalsurveillanceExposureassessmentDevelop exposureregistriesAddresshotspotsProtecting the Nanotechnology WorkforceDevelop categorical and specific exposure limitsRisk Management18 | Protecting the Nanotechnology Workforce about hazards, risks, and risk manage

ment approaches. • Support epidemiologic studies for nano

material workers, including medical, cross-sectional, prospective cohort, and exposure studies. • Assess and promote national and inter

national adherence with risk manage

ment guidance. The overall focus of the strategic plan will be to continue to generate data, information, and knowledge to protect the nanotechnology workforce, by using effective risk management techniques and particularly keeping exposure below occupational limits. Research is proposed to develop and update good risk-management practices, including categorical and specif

ic exposure limits. Research data and informa

tion will be cataloged and shared via informat

ics (resources, devices, and methods required to optimize the acquisition, storage, retrieval, and use of information). 

## 4.4 Coordination with the National Nanotechnology Initiative NIOSH research priorities address many of the strategic goals proposed by the NNI Strategy for Nanotechnology Environmental, Health, and Safety Research. Table 1 shows the align

ment of the NIOSH NTRC strategic goals and 10 NTRC critical research areas with the NNI EHS priority research needs (Appendix A). 

## 4.5 Proposed NIOSH NTRC Research The following proposed research for FY2013– FY2016 has been coalesced to focus on specif

ic research needs to fill data gaps (see Section 4.2) and the EHS priority research needs of the NNI (see Section 4.4). As knowledge gaps are filled and as resources become available, these research priorities could change. Strategic Goal 1 (PPNANSG1): Increase un derstanding of new hazards and related health risks to nanomaterial workers. Intermediate Goal 1.1 (PPNANIG1.1): Conduct market forecasting and review available sur

veillance data to determine emerging commer

cial ENMs and next-generation uses of exist

ing ENMs. Activity/Output Goal 1.1.1 (PPNANAOG1.1.1): Prioritize high-volume emerging ENMs to identify the next candidates for toxicological testing and field evaluation of workplace expo

sures. Performance Measure 1.1.1: In FY2013, com

plete an initial market research and forecasting report for internal use. Update the report with

in 3 years. Activity/Output Goal 1.1.2 (PPNANAOG1.1.2): Complete a secondary market analysis on high volume nanomaterials. Performance Measure 1.1.2: By FY2014, complete a market landscape analysis of formu

lators and users of nano titanium dioxide, silver, graphene and cellulose. Identify key industries using these materials in current products and those to be commercialized in the near term. Intermediate Goal 1.2 (PPNANIG1.2): Conduct research to contribute to the understanding of the toxicology and internal dose of emerging ENMs. Activity/Output Goal 1.2.1 (PPNANAOG1.2.1): Evaluate acute and chronic effects in the lungs and in other organ systems and tissues. Deter

mine dose-response and time-course relation

ships. Determine rates of clearance of these nanoparticles after pulmonary exposure and translocation to systemic organs; characterize systemic effects. Performance Measure 1.2.1: Complete tox

icologic studies on ENMs such as nanosilver, graphene, and nanocellulose; present the data via the Society of Toxicology and publish in the peer-reviewed literature by FY2016.Protecting the Nanotechnology Workforce | 19(continured)Table 1. Alignment of Critical Research Areas with the Five Strategic Goals of the NIOSH NTRC and the NNI EHS Priority Research Needs (RNs)NIOSH NTRC Strategic Goal/Critical Research AreaIncrease understanding of new hazardsand related healthrisks to nanomaterialworkersExpand understanding of the initialhazard findings ofengineered nanomaterialsSupport the creation of guidance materials to informnanomaterial workers andemployers about hazards,risks, and risk managementapproachesSupport epidemiologicstudies for nanomaterialworkers, including medical, cross–sectional, prospective cohort, and exposure studiesAssess and promotenational and international adherence withrisk managementguidanceToxicity and internal dose*3-RN1†3-RN23-RN33-RN43-RN54-RN13-RN1†3-RN23-RN33-RN43-RN5Measurement methods1-RN11-RN21-RN32-RN13-RN21-RN11-RN21-RN32-RN13-RN220 | Protecting the Nanotechnology WorkforceTable 1 (Continued). Alignment of Critical Research Areas with the Five Strategic Goals of the NIOSH NTRC and the NNI EHS Priority Research Needs (RNs)(continured)NIOSH NTRC Strategic Goal/Critical Research AreaIncrease understanding of new hazardsand related healthrisks to nanomaterialworkersExpand understanding of the initialhazard findings ofengineered nanomaterialsSupport the creation of guidance materials to informnanomaterial workers andemployers about hazards,risks, and risk managementapproachesSupport epidemiologicstudies for nanomaterialworkers, including medical, cross–sectional, prospective cohort, and exposure studiesAssess and promotenational and international adherence withrisk managementguidanceExposure assessment2-RN12-RN33-RN24-RN15-RN22-RN12-RN33-RN24-RN15-RN2Epidemiology and surveillance2-RN12-RN32-RN43-RN65-RN25-RN2Risk assessment5-RN15-RN25-RN55-RN15-RN25-RN55-RN35-RN4Protecting the Nanotechnology Workforce | 21*A check mark () indicates that a goal is currently being addressed by projects within the NIOSH critical research area.†Alphanumeric identifications indicate specific NNI priority research needs (see Appendix A) being met by the NIOSH projects in each critical research area.‡International engagement is a priority of the NNI and a critical component of the 2011 NNI EHS Research Strategy. However, it is not identified as a research need in the NNI Strategy.§NIOSH will work with other governments to determine global adherence.¶The NNI EHS plan does not address applications of nanomaterials for EHS use. However, the NNI strategic plan includes applications as a driving force behind several Federal nano-technology programs, and it has the potential to improve safety and health, such as through the development of advanced sensors or PPE.NIOSH NTRC Strategic Goal/Critical Research AreaIncrease understanding of new hazardsand related healthrisks to nanomaterialworkersExpand understanding of the initialhazard findings ofengineered nanomaterialsSupport the creation of guidance materials to informnanomaterial workers andemployers about hazards,risks, and risk managementapproachesSupport epidemiologicstudies for nanomaterialworkers, including medical, cross–sectional, prospective cohort, and exposure studiesAssess and promotenational and international adherence withrisk managementguidanceEngineering controlsand PPE2-RN15-RN15-RN22-RN15-RN15-RN25-RN2Fire and explosion safety1-RN51-RN5Recommendationsand guidance5-RN‡5-RN§5-RN¶5-RN2Global collaborations‡§Applications¶Table 1 (Continued). Alignment of Critical Research Areas with the Five Strategic Goals of the NIOSH NTRC and the NNI EHS Priority Research Needs (RNs)22 | Protecting the Nanotechnology Workforce Performance Measure 1.2.2: Identify probable combinations of nanomaterial uses and if fre

quent combinations are identified, conduct pre

liminary toxicologic evaluations to determine if synergistic effects occur by FY2016. Intermediate Goal 1.3 (PPNANIG1.3): Deter

mine whether nanomaterial toxicity can be cat

egorized on the basis of physicochemical prop

erties and mode of action. Activity/Output Goal 1.3.1 (PPNANAOG1.3.1): Systematically investigate the physical and chem

ical properties of particles that influence their toxicity (e.g., size, shape, surface area, solubility, chemical properties, and trace components). Activity/Output Goal 1.3.2 (PPNANAOG1.3.2.): Determine the biological mechanisms for tox

ic effects (e.g., oxidant stress, dissolution, fibro

genicity, and hydrophobicity) and how the key chemical and physical factors may influence these mechanisms. Activity/Output Goal 1.3.3 (PPNANAOG1.3.3): Integrate mechanistic models (including an

imal models and in vitro screening tests) for assessing the potential toxicity of new nano

materials, and provide a basis for developing predictive algorithms for structure/function re

lationships and comparative toxicity analyses for risk assessment. Determine whether toxico

logic data from new studies can be linked to ex

isting toxicologic data. Performance Measure 1.3.1: By FY2016, de

termine whether ENMs can be categorized (hazard banded) on the basis of physicochemical properties and/or the toxicologic mode of action. Intermediate Goal 1.4 (PPNANIG1.4): Con

duct nanomaterial workplace exposure assess

ments at sites developing, producing, or using emerging ENMs. Activity/Output Goal 1.4.1 (PPNANAOG1.4.1): Collaborate with nanomaterial businesses to identify processes that may release nanomate

rials during manufacturing or use of ENMs. Evaluate potential exposures and document risk mitigation processes. Performance Measure 1.4.1.1: Complete a minimum of four field evaluations per year at facilities producing or using emerging ENMs. By FY2014, publish summary findings in a peer-reviewed journal. Performance Measure 1.4.1.2: Evaluate ENM use and risk management practices at user fa

cilities across the life cycle, including secondary and tertiary facilities. By FY2015, publish sum

mary findings in a peer-reviewed journal. Strategic Goal 2 (PPNANSG2): Expand un derstanding of the initial hazard findings of engineered nanomaterials. Intermediate Goal 2.1 (PPNANIG2.1): Conduct research to evaluate the adverse chronic effects of single-walled carbon nanotubes, multi-walled carbon nanotubes, and carbon nanofibers. Activity/Output Goal 2.1.1 (PPNANAOG2.1.1): Conduct toxicologic testing to determine the potential of single-walled carbon nanotubes, multi-walled carbon nanotubes, and carbon nanofibers to have long-term pulmonary effects (fibrosis, lung cancer, mesothelioma). Performance Measure 2.1.1: By FY2016, pub

lish a report on the carcinogenicity of carbona

ceous nanomaterials, based on completed carci

nogenicity-toxicology studies. Intermediate Goal 2.2 (PPNANIG2.2): Deter

mine whether human biomarkers of nanomate

rial exposure and/or response can be identified. Activity/Output Goal 2.2.1 (PPNANAOG2.2.1): Conduct research to determine whether blood, urine, or nasal lavage markers can accurately predict initiation and progression of adverse re

sponses to ENMs. Performance Measure 2.2.1: By FY2017, pub

lish results of human biomarker studies.Protecting the Nanotechnology Workforce | 23 Activity/Output Goal 2.2.2 (PPNANAOG2.2.2): Conduct research to determine whether car

diovascular or immune responses are sensitive indicators of pulmonary exposure to ENMs. Performance Measure 2.2.2: By FY2016, pub

lish findings on cardiovascular and immune re

sponses to pulmonary exposure to ENMs. Intermediate Goal 2.3 (PPNANIG2.3): De

termine the relevance of in vitro and in vivo screening tests to worker response to inhala

tion of ENMs. Activity/Output Goal 2.3.1 (PPNANAOG 2.3.1): Evaluate the relationship of deposition patterns and biological responses to pulmonary bolus exposure (intratracheal instillation or pharyn

geal aspiration) vs. exposure extended over time (inhalation) of ENMs in rodent models. Performance Measure 2.3.1: By FY2016, pub

lish findings on the relationship of deposition patterns and biological responses to pulmonary bolus exposure vs. exposure extended over time. Activity/Output Goal 2.3.2 (PPNANAOG 2.3.2): Evaluate predictive in vitro screening tests for fibrogenicity, genotoxicity, and/or cell transfor

mation. Performance Measure 2.3.2: Publish results from predictive in vitro screening tests for fibro

genicity, genotoxicity, and/or cell transformation, over the next 2 to 4 years (FY2014–FY2016). Intermediate Goal 2.4 (PPNANIG2.4): Con

duct research on measurement methods for nanomaterials. Activity/Output Goal 2.4.1 (PPNANAOG2.4.1): Continue interactions with national metrology institutes and qualify cellulose and single-walled CNT nanoscale reference materials (RMs) and/ or benchmark materials for evaluating measure

ment tools, instruments, and methods for expo

sure assessment and toxicology. Performance Measure 2.4.1.1: By FY2014, com

plete a round-robin evaluation of a transmission electron microscopy (TEM) sample-preparation procedure using National Institute of Stan

dards and Technology (NIST) gold nanoparti

cle RMs 8011, 8012, and 8013. Performance Measure 2.4.1.2: By FY2014, translate this TEM sample-preparation proce

dure into a consensus standard practice or guide through ASTM International Committee E56: Nanotechnology. Performance Measure 2.4.1.3: Within 4 years (FY2016), utilize NIST gold nanoparticle RMs 8011, 8012, and 8013 to evaluate filter- and grid-based sample-collection techniques and TEM analysis for spherical ENMs. Performance Measure 2.4.1.4: By FY2016, develop measurement protocols for dynamic light scattering (hydrodynamic diameter), laser Doppler electrophoresis (zeta potential), and gas adsorption (surface area) measurements that utilize RMs (as appropriate) for particle characterization for internal use to promote re

producibility of testing. Performance Measure 2.4.1.5: By FY2016, develop instrument sampling cards that pro

vide a succinct summary on the operation and utility of condensation particle counters, scan

ning mobility particle sizers, and diffusion chargers for internal use to promote measure

ment quality. Activity/Output Goal 2.4.2 (PPNANAOG2.4.2): Understand relationships between laboratory instrumentation used to characterize aerosols for toxicology studies and field-measurement instrumentation used to characterize workplace atmospheres. Performance Measure 2.4.2: By FY2016, com

plete a series of studies to evaluate test atmo

spheres with real-time and integrated labora

tory and field-measurement instruments for a range of metrics, including particle number, size, and surface area.24 | Protecting the Nanotechnology Workforce Activity/Output Goal 2.4.3 (PPNANAOG2.4.3): Conduct further research on the dustiness testing of powders and to benchmark the Venturi (Uni

versity of North Carolina) dustiness testing de

vice against a more traditional dustiness test (e.g., a standard method prescribed in EN 15051). Performance Measure 2.4.3: By FY2015, com

pare the Venturi dustiness testing device against at least one other method for a range of fine and nanoscale materials. Activity/Output Goal 2.4.4 (PPNANAOG2.4.4): Conduct further research on determining the advantages and limitations of direct reading in

struments in assessing nanoparticle work-place emissions and exposures. Performance Measure 2.4.4: By FY2015, pub

lish at least one further study on the perfor

mance of direct reading instruments for assess

ing nanoparticle emissions or exposures in the workplace. Activity/Output Goal 2.4.5 (PPNANAOG2.4.5): Develop and improve methods and approach

es (including direct reading and time-integrat

ed sampling) for assessing workplace exposures to ENMs. Performance Measure 2.4.5.1: By FY2015, publish updated strategies for assessing work

place exposures. Performance Measure 2.4.5.2: By FY2015, validate method 5040 for a series of CNT in

cluding. NIST Standard Reference Materi

al 248: Single-Wall Carbon Nanotubes (Raw Soot). Activity/Output Goal 2.4.6 (PPNANAOG2.4.6): Evaluate scanning electron microscopy, trans

mission electron microscopy, and dark-field mi

croscopy as analytical tools for measurement of carbon nanotubes using NIST Standard Refer

ence Material 248: Single-Wall Carbon Nano

tubes (Raw Soot). Performance Measure 2.4.6: By FY2015, pub

lish a microscopy method (or methods) for sample preparation, identification, and/or pos

sible semi-quantification that is applicable to some ENMs. Activity/Output Goal 2.4.7 (PPNANAOG2.4.7): Conduct research to advance the use of nano

materials in the development of sensors (e.g., detection of harmful chemicals) and oth

er health and safety–related applications that can be used in the workplace to ensure effective control of exposure. Performance Measure 2.4.7.1: By FY2016, develop an effective sensor employing nano

materials for the real-time measurement of a workplace agent, and publish the results. Performance Measure 2.4.7.2: By FY2016, compile and publish a compendium on appli

cations of nanotechnology to improve work

place safety and health. Intermediate Goal 2.5 (PPNANIG2.5): Con

duct research to better define the potential fire and explosion safety hazards of ENMs. Activity/Output Goal 2.5.1 (PPNANAOG2.5.1): Identify physical and chemical properties that contribute to dustiness, combustibility, flam

mability, explosibility, and electromagnetic haz

ards of ENMs. Performance Measure 2.5.1: By FY2014, pub

lish preliminary findings from explosibility test

ing of some ENMs. Performance Measure 2.5.2: By FY2016, pub

lish findings that may influence the National Fire Protection Association (NFPA) or Depart

ment of Transportation (DOT) flammability placard information and the DOT Emergency Response Guidebook. Intermediate Goal 2.6 (PPNANIG2.6): Devel

op and use informatics to process and commu

nicate information.Protecting the Nanotechnology Workforce | 25 Activity/Output Goal 2.6.1 (PPNANAOG2.6.1): Create a harmonized database to share exposure measurement, control, and epidemiologic data. Performance Measure 2.6.1: By FY2015, have a populated dataset containing NIOSH results on measurement, control, and epidemiologic data. Activity/Output Goal 2.6.2 (PPNANAOG2.6.2): Lead the nanoinformatics community to devel

op an open literature monograph on nanoinfor

matics principles and practice. Performance Measure 2.6.2: Complete and publish the nanoinformatics monograph by FY2015. Strategic Goal 3 (PPNANSG3): Support the creation of guidance materials to inform nanomaterial workers, employers, health pro fessionals, regulatory agencies, and decisionmakers about hazards, risks, and risk man agement approaches. Intermediate Goal 3.1 (PPNANIG3.1): Develop categorical and specific exposure limits. Activity/Output Goal 3.1.1(PPNANAOG3.1.1): Conduct a risk assessment for high-volume ENMs. Performance Measure 3.1.1: By FY2015, com

plete a quantitative risk assessment (QRA) on ultrafine and fine materials from existing stud

ies. Evaluate QRA methods for nanomaterials. Start QRA for nanoparticles, with use of new NIOSH data. Use NIOSH nanoparticle data to calibrate and validate dosimetry models for nanoparticles. Activity/Output Goal 3.1.2 (PPNANAOG3.1.2): Develop a risk-assessment framework for eval

uating the hazard and predicting the risk of ex

posure to ENMs. Performance Measure 3.1.2: By 2017, devel

op a risk-assessment framework to rank haz

ard and estimate risk from exposure to selected ENMs in the workplace. Activity/Output Goal 3.1.3 (PPNANAOG3.1.3): Use a nanomaterial hazard banding classifica

tion scheme to group ENMs. Performance Measure 3.1.3: By FY2016, de

velop a hazard banding classification scheme for ENMs on the basis of toxicological, chemi

cal, and physical properties. Intermediate Goal 3.2 (PPNANIG3.2): Con

duct research to better understand engineering controls and PPE for use with ENMs. Activity/Output Goal 3.2.1 (PPNANAOG3.2.1): Evaluate the effectiveness of engineering con

trol techniques for ENMs and develop new ap

proaches as needed. Performance Measure 3.2.1: Conduct field investigations of workplaces where ENMs are manufactured and used to evaluate existing en

gineering controls and make recommendations on improving exposure control. By FY2015, publish case studies and workplace survey re

ports, and by FY 2016, publish updated engi

neering control solutions. Activity/Output Goal 3.2.2 (PPNANAOG3.2.2): Conduct laboratory evaluations of commercial

ly available engineering controls for a variety of common ENM production, handling, and downstream processes. Performance Measure 3.2.2: By FY2016, pub

lish in-depth reports and journal articles on the effectiveness of the commercially available en

gineering control devices. Activity/Output Goal 3.2.3 (PPNANAOG3.2.3): Evaluate the effectiveness of PPE (respirators, and protective clothing including gloves) for reducing worker exposures to ENMs. Performance Measure 3.2.3: By FY2016, pub

lish updated guidance on the effectiveness of PPE for reducing worker exposures to ENMs. Intermediate Goal 3.3 (PPNANIG3.3): Incor

porate Prevention through Design (PtD) into nanomaterial health and safety programs.26 | Protecting the Nanotechnology Workforce Activity/Output Goal 3.3.1 (PPNANAOG3.3.1): Promote PtD principles for nanomaterials, in

cluding safer nanomaterials that have the same functionality; process containment and con

trol; and management system approaches to in

clude occupational safety and health into the nanoparticle synthetic process, product devel

opment, and product manufacture. Performance Measure 3.3.1: By FY2015, publish a document specific to PtD for nano

materials. Intermediate Goal 3.4 (PPNANIG3.4): Foster the collection, management, and dissemination of relevant information to protect nanomateri

al workers. Activity/Output Goal 3.4.1 (PPNANAOG3.4.1): Develop and disseminate effective information, education, and training materials to various tar

get audiences such as nanotechnology workers and employers, occupational safety and health professionals, policy-makers, decision-makers, and/or the scientific community. Performance Measure 3.4.1.1: By FY2015, create nanomaterial guidance documents for workers, including small business and construc

tion workers. Performance Measures 3.4.1.2: By FY2015, update Approaches to Safe Nanotechnology: Man

aging the Safety and Health Concerns Associated with Engineered Nanomaterials . Performance Measures 3.4.1.3: By FY2016, up

date the Progress Report on the NIOSH Nano

technology Research and Communication Effort. Performance Measure 3.4.1.4: Create new guidance documents on use of engineering con

trols, PPE, and PtD, as per Performance Mea

sures 3.2.1, 3.2.2, 3.2.3, and 3.3.1. Performance Measure 3.4.1.5: By FY2016, support a conference on risk management of ENMs, with a focus on engineering controls. Performance Measure 3.4.1.6: By FY2016, evaluate Nanomaterial Safety Data Sheets for adherence with the updated OSHA HazCom rule (including the use of Global Harmoniza

tion System), and issue guidance documents based on the updated findings. Intermediate Goal 3.5 (PPNANIG3.5): Enhance global workplace safety and health through in

ternational activities. Activity/Output Goal 3.5.1 (PPNANAOG3.5.1): Establish and maintain national and interna

tional partnerships so that knowledge gaps, re

search needs and priorities, approaches, and da

tabases could be shared. Performance Measure 3.5.1.1: Strengthen co

ordination of research through governmentlevel organizations such as the Organization for Economic Cooperation and Development (OECD) and United Nations (UN). Performance Measure 3.5.1.2: By FY2015, expand collaborations to developing nations. Activity/Output Goal 3.5.2 (PPNANAOG3.5.2): Improve sharing critical data globally. Performance Measure 3.5.2.1: By FY016, de

velop a global portal for information on ENMs relevant to occupational safety and health. Performance Measure 3.5.2.2: If feasible, by FY2016 initiate the development of a global exposure registry database. Performance Measure 3.5.2.3: In FY2015, par

ticipate in OECD Nanomaterial Safety Testing Program by sponsoring nanomaterial testing and by data exchange. Activity/Output Goal 3.5.3 (PPNANAOG 3.5.3): Lead the development of global standards on oc

cupational safety and health for nanotechnology. Performance Measure 3.5.3.1: Over the next 3 years (FY2014–FY2016), lead the develop

ment of at least one standard in the Interna

tional Organization for Standardization.Protecting the Nanotechnology Workforce | 27 Performance Measure 3.5.3.2: Over the next 3 years (FY2014–FY2016), lead the development of at least one guidance document for the UN. Performance Measure 3.5.3.3: Over the next 3 years (FY2014–FY2016), lead the development of at least one guidance document for the OECD. Strategic Goal 4 (PPNANSG4): Support epi demiologic studies for nanomaterial workers, including medical, cross-sectional, prospec tive cohort, and exposure studies. Intermediate Goal 4.1 (PPNANIG4.1): Con

duct epidemiologic research and evaluate fea

sibility of conducting surveillance of nanoma

terial workers. Activity/Output Goal 4.1.1 (PPNANAOG4.1.1): Complete the epidemiological health studies of U.S. workers exposed to CNTs and carbon nanofibers. Performance Measure 4.1.1: By FY2016, complete data collection for industry-wide ex

posure and epidemiological studies of workers exposed to carbonaceous nanomaterials. Activity/Output Goal 4.1.2 (PPNANAOG4.1.2): Evaluate the need for and feasibility of initiat

ing worker exposure registries for workers ex

posed to existing nanomaterials (e.g., titanium dioxide, CNTs) or producing and using new nanomaterials. Performance Measure 4.1.2: By FY2016, de

velop a template and begin population of work

er exposure registries. Activity/Output Goal 4.1.3 (PPNANAOG4.1.3): Integrate nanotechnology safety and health guidance into existing hazard surveillance sys

tems. Determine whether these systems are ad

equate by conducting evaluations. Performance Measure 4.1.3: By FY2016, update NIOSH Current Intelligence Bulletin 60: Interim Guidance for the Medical Screen

ing and Hazard Surveillance of Workers Po

tentially Exposed to Engineered Nanoparticles [NIOSH 2009d]. Strategic Goal 5 (PPNANSG5): Assess and promote national and international adherence with risk management guidance. Intermediate Goal 5.1 (PPNANIG5.1): Deter

mine the extent to which control measures are being adopted by industry. Identify any barriers to use of controls and partner with business to address barriers. Activity/Output Goal 5.1.1 (PPNANAOG 5.1.1): Determine whether NIOSH or other precautionary guidance recommendations are being adopted by businesses. Performance Measure 5.1.1: Within the next 3 years, conduct formal and informal assess

ments of the controls used in ENM-produc

ing or -handling facilities. By FY2016, publish findings. Activity/Output Goal 5.1.2 (PPNANAOG 5.1.2): Develop a plan for industrial sectors where ad

herence to good risk-management practice is low. Performance Measure 5.1.2: By 2016, publish a plan for intervening in industry sectors with low adherence to risk management guidance. Activity/Output Goal 5.1.3 (PPNANAOG 5.1.3): Develop a follow-back program for the field in

vestigation activities. Performance Measure 5.1.3: By 2014, have a follow-back program in place to determine if facilities are implementing suggestions from the field investigations. Activity/Output Goal 5.1.4 (PPNANAOG 5.1.4): Support the International Commission on Oc

cupational Health (ICOH) and other orga

nizations in assessing whether precautionary guidance recommendations are being adopted worldwide. Performance Measure 5.1.4: By 2016, sup

port ICOH in developing a plan to address lo

cations where adherence to good risk-manage

ment practice is low.Protecting the Nanotechnology Workforce | 29 

# 5 OUTPUTS
A summary of NIOSH NTRC research out

puts and accomplishments is presented in the report Filling the Knowledge Gaps for Safe Nano

technology in the Workplace [NIOSH 2012a]. 

## 5.1 NIOSH Publications on Nanotechnology Since 2009 NIOSH NTRC scientists will continue to de

velop documentation that provides guidance and technical information for workers, employ

ers, health professionals, regulatory agencies, and decision-makers in government, academia, industry, and labor. Examples of such documen

tation include the following:
• Current Intelligence Bulletin (CIB) 65, Oc

cupational Exposure to Carbon Nanotubes and Carbon Nanofibers , DHHS (NIOSH) Publication No. 2013–145 [NIOSH 2013]. This document includes a recommended exposure limit for carbon nanotubes and nanofibers. It is available at http://www.cdc. gov/niosh/docs/2013-145/ . • Filling the Knowledge Gaps for Safe Nan

otechnology in the Workplace , DHHS (NIOSH) Publication No. 2013–101 [NIOSH 2012a]. It is available at http:// www.cdc.gov/niosh/docs/2013-101/ . • Current Intelligence Bulletin (CIB) 63, Oc

cupational Exposure to Titanium Dioxide , DHHS (NIOSH) Publication No. 2011– 160 [NIOSH 2011]. This document in

cludes a recommended exposure limit for both fine and ultrafine (nano) titanium dioxide (TiO 2 ). It is available at http:// www.cdc.gov/niosh/docs/2011-160/ . • General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories , DHHS (NIOSH) Publi

cation No. 2012–147 [NIOSH 2012b]. It is available at http://www.cdc.gov/niosh/ docs/2012-147/ . • NIOSH sponsored a supplement to the Journal of Occupational and Environmental Medicine, entitled Selected Papers from the Nanomaterials and Worker Health, Medi

cal Surveillance, Exposure Registries and Epidemiologic Research Conference, July 21–23, 2010 [ JOEM 53(6S):S1–S112].
• Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center , DHHS (NIOSH) Publication No. 2010–104 [NIOSH 2009a]. This document reports on the status of nanotechnology research conducted by the NIOSH NTRC in 2007–2008. It is available at http://www. cdc.gov/niosh/docs/2010-104/ . • Approaches to Safe Nanotechnology: Manag

ing the Health and Safety Concerns Associat

ed with Engineered Nanomaterials , DHHS (NIOSH) Publication No. 2009–125 [NIOSH 2009c]. This document served a dual purpose of summarizing NIOSH’s current thinking and interim recommen

dations and fostering the exchange infor

mation to ensure that no worker suffers material impairment of safety or health as nanotechnology develops. It is available at http://www.cdc.gov/niosh/docs/2009-125/ . • Interim Guidance for Medical Screening and Hazard Surveillance for Workers Poten

tially Exposed to Engineered Nanoparticles , DHHS (NIOSH) Publication No. 2009– 116 [NIOSH 2009d]. This document recommended prudent precautionary in

terim measures for reducing work-related exposures and assessing potential risk. It is available at http://www.cdc.gov/niosh/ docs/2009-116/ .30 | Protecting the Nanotechnology Workforce 

## 5.2 NIOSH Peer-Reviewed Publications NIOSH NTRC scientists will continue to publish results of research as the data become available. More than 500 peer-reviewed articles were published between 2004 and 2012 that addressed scientific and technical issues in the field of nanotechnology. NIOSH will contin

ue to evaluate the utility of its publications and their impact on the scientific, regulatory, and occupational health community. 

## 5.3 Sponsored Conferences The NIOSH NTRC will continue to partner with others in sponsoring and conducting con

ferences on nanotechnology. To date, NIOSH has co-sponsored 15 international nanomate

rial health and safety meetings. NTRC staff members also have participated on several sci

entific and technical panels convened by gov

ernment agencies, nongovernmental agencies, and professional associations. 

## 5.4 Presentations NTRC staff will continue to deliver presenta

tions nationally and internationally concerning occupational safety and health issues associat

ed with nanotechnology, including presenta

tions at scientific conferences and to trade and professional associations. To date, NTRC staff members have given more than 650 presenta

tions on nanomaterial health and safety topics.Protecting the Nanotechnology Workforce | 31 

# 6 RESEARCH TO PRACTICE (r2p)
Research to practice (r2p) involves the transla

tion of research into products, practices, and us

able information. The NIOSH NTRC nano

technology strategic plan reflects the r2p vision to work with partners and stakeholders to trans

late research findings into NIOSH products (e.g., guidance documents, instrumentation, nanopar

ticle filtration methods, and exposure controls) that will be used to reduce or prevent worker in

jury and illness from nanotechnology. R2p also involves moving others to action. NIOSH will continue to work with national and international organizations to translate research to actions that will protect the nanomaterial workforce. 

## 6.1 Capacity Building through Technical Assistance The NIOSH NTRC is currently collaborat

ing with a number of industries to develop appropriate engineering controls and ef

fective administrative practices for the safe handling of nanomaterials. Specifically, the NTRC will continue to work with indus

try and labor in evaluating workplace expo

sures to ENMs and provide recommenda

tions that will minimize worker exposures. NIOSH has several complimentary re

sources that reside in the Health Hazard Evaluation, Industrywide Study, and Engi

neering Control Technology Programs that can provide expertise in augmenting ongo

ing NTRC efforts of evaluating workplace nanoparticle exposures, related health ef

fects, and risk management efforts.The NIOSH NTRC will continue to make rec

ommendations and provide information based on its research and findings report

ed in the published scientific literature. The recommendations will pertain to all areas of risk management described in Section 4.1.Protecting the Nanotechnology Workforce | 33 

# 7 INTERMEDIATE CUSTOMERS AND INTERMEDIATE OUTCOMES

7.1 Federal Government Agencies NIOSH will conduct and coordinate research with other agencies to foster the responsible development and safe use of nanotechnology, as identified by the NNI. Specifically, NIOSH will continue to collaborate with OSHA, EPA, NIST, NIEHS, and the Consumer Product Safety Commission (CPSC). 

## 7.2 Standards Development Organizations NIOSH actively participates in the develop

ment of national and international standards for promoting the health and safety of workers in the nanotechnology industries. The NIOSH NTRC participates in the American Nation

al Standards Institute (ANSI) Nanotechnolo

gy Standards Steering Panel, which coordinates the identification and development of critical standards in all areas of nanotechnology. NIOSH NTRC scientists also participate in the ASTM International E56 Committee on Nan

otechnology, which is developing an integrated family of standards. Committee E56.03 is ad

dressing environmental and occupational safe

ty and health. NIOSH NTRC scientists will continue leading as chair and members of the U.S. Technical Ad

visory Group to the International Organization for Standardization (ISO) Technical Commit

tee 229 on Nanotechnologies (ISO TC 229). Work on instrumentation-related standards will continue with committees of the International Electrotechnical Commission (IEC). NIOSH NTRC scientists will also contin

ue collaboration on the development of nano

technology-related guidance with authoritative bodies including the National Council on Radi

ation Protection and Measurements. 

## 7.3 Industry, Labor, and Academia NIOSH is coordinating input from industry, labor, academics, and a wide range of govern

ment agencies in creating guidance for occu

pational health surveillance. Additionally, the NIOSH NTRC plans to coordinate input from those same groups of partners and stake

holders with the goal of developing standard

ized data systems for epidemiological research in workplaces producing and using nanoma

terials. Through collaborations with industry, government, and academia, NIOSH [2009c] has developed a “best practices” document, Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials [DHHS (NIOSH) Publication No. 2009–125; http://www.cdc. gov/niosh/docs/2009-125/ ] and will continue to develop other communication materials on the safe handling of ENMs. NIOSH NTRC is continuing to work with industry to character

ize occupational exposure to ENMs and im

plement effective risk-management practices to minimize worker exposure to ENMs. 

## 7.4 Professional Organizations NIOSH is collaborating with various profes

sional organizations, including the American Industrial Hygiene Association (AIHA) and34 | Protecting the Nanotechnology Workforce National Safety Council (NSC), to identify mutual efforts for developing new worker train

ing programs. 

## 7.5 Research Collaborations NIOSH has established several national and international collaborations to advance re

search into the safe use of nanotechnology. The NIOSH NTRC participates in the National Nanotechnology Initiative (NNI) and has con

tributed to the nanotechnology environmental, health, and safety (EH&S) research strategy for the nation through the working group of Nan

otechnology Environmental and Health Impli

cations (NEHI). NIOSH’s strategic research plan and activities have been developed to ad

dress the occupational safety and health issues in the NSET/NEHI plan [NNI 2011]. 

## 7.6 International Activities NIOSH will continue to engage with a num

ber of international entities at all levels—as prin

ciple investigator as well as in national, region

al, and global organizations. At the national organization level, the NIOSH NTRC has been communicating and collaborating with the United Kingdom Institute of Occupational Medicine and the Health and Safety Laborato

ry; the Netherlands Organization for Applied Scientific Research (TNO); the French Agen

cy for Food, Environmental and Occupational Health and Safety (ANSES); the Finnish In

stitute of Occupational Health; and the Aus

tralian Safety and Compensation Council (Safe Work Australia). NIOSH is collaborating with the OECD to build cooperation, coordination, and commu

nication between the United States and 30 OECD member countries, including the Eu

ropean Union (EU), and more than 180 non

member economies. NIOSH is also work

ing with the UN World Health Organization (WHO); the UN International Labour Orga

nization (ILO); the International Organiza

tion for Standardization (ISO); the Interna

tional Electrotechnical Commission (IEC), the International Commission on Occupational Health (ICOH); and the International Coun

cil on Nanotechnology (ICON) on global proj

ects of information dissemination and commu

nication.Protecting the Nanotechnology Workforce | 35 

# 8 OUTCOMES
Nanotechnology is a rapidly developing area of science and technology that promises great ben

efits. To realize these benefits, it is important to protect workers potentially exposed to ENMs in nanomaterial research, production, and use [Schulte and Salamanca-Buentello 2007; Nas

terlack et al. 2008; Howard and Murashov 2009]. The NIOSH NTRC strategic plan is de

signed to identify and create the information needed for risk management programs that will control and prevent negative impacts on work

er health. Outcomes of the NIOSH NTRC re

search will be translated into products that can be used by the nanotechnology community to develop and implement appropriate risk man

agement practices to minimize worker exposure to ENMs. NIOSH also will evaluate how re

search results and risk management guidance developed by NIOSH influence others to take action to prevent exposure to hazards related to ENMs. NIOSH will assess the extent to which its re

search efforts have addressed each element of the risk management process (illustrated in Fig

ure 6) and determine how the outcomes of re

search have influenced others to take action to prevent exposure to hazards related to ENMs. NIOSH will publish a report of its research outcomes for the 2013–2016 period. A summa

ry of proposed research for FY2013–2014 and FY2015–2016 is shown in Appendix BProtecting the Nanotechnology Workforce | 37 

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# Appendix A Comprehensive Chart of the NNI 2011 EHS Research Needs [National Nanotechnology Initiative: Environmental, Health, and Safety Research Strategy. Washington, DC: United States Executive Office of the President, Office of Science and Tech

nology Policy, Nanotechnology Environmental and Health Implications (NEHI) Working Group, Table D–1.]Protecting the Nanotechnology Workforce | 41 40 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs 1. Nanomaterial Measurement Infrastructure Research Needs Develop measurement tools to detect and identify engineered nanoscale materials in products and rele

vant matrices and determine their physico-chemical properties throughout all stages of their life cycles. Develop measurement tools for determination of biological response and to enable assessment of hazards and exposure for humans and the environment from engineered nanomaterials and nanotechnology-based products throughout all stages of their life cycles. RN#1. Develop measurement tools for determination of physico-chemical properties of ENMs in relevant media and during the life cycles of ENMs and NEPs • Physical dimensions and morphology: size, size distribution, char

acteristic dimensions, shape • Internal structure: atomic-molecular, core-shell • Surface and interfacial properties: surface charge, zeta potential, surface structure, elemental composition, surface-bound molecular coatings and conjugates, reactivity • Bulk composition: elemental or molecular composition, crystalline phase(s) • Dispersion properties: degree and state of dispersion • Mobility and other transport properties: diffusivity, transport in biological and environmental matrices RN#2. Develop measurement tools for detection and moni

toring of ENMs in realistic ex

posure media and conditions during the life cycles of ENMs and NEPs • Sampling and collection of ENMs • Detecting the presence of ENMs • Quantity of ENMs-concentration based on surface area, mass, and number concentrations • Size and size distribution of ENMs • Spatial distribution of ENMs • Discriminating ENMs from ambient NMs such as combustion products and welding fumes • Discriminating multiple types of ENMs such as metals and metal oxides RN#3. Develop measurement tools for evaluation of transfor

mations of ENMs in relevant media and during the life cy

cles of ENMs and NEPs • Agglomeration and de-agglomeration • Dissolution and solubility • Absorption of natural organic matter and bioconstituents • Oxidation and reduction • Deposition of ENMs on surfaces

(continued) Table D–1. The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 41 40 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs RN#4. Develop measurement tools for evaluation of biolog

ical responses to ENMs and NEPs in relevant media and during the life cycles of ENMs and NEPs • Adequacy of existing assays • New assays or high-throughput, high content assays • Correlation of biological responses with physico-chemical properties • Surface reactivity at the interfaces between ENMs and biological receptors • Biomarkers of toxicological response RN#5. Develop measurement tools for evaluation of release mechanisms of ENMs from NEPs in relevant media and during the life cycles of NEPs • Release by fire, combustion, and incineration • Release by mechanical degradation, such as abrasion, deformation, and impact • Release by dissolution of matrix material • Release by chemical reactions of the matrix material • Release by photo-induced degradation of the matrix material • Release by consumer interactions, such as spraying, mouthing, and swallowing • Release by interactions with biological organisms in the envi

ronment 2. Human Exposure Assessment Research Needs Identify potential sources, characterize the exposure scenarios, and quantify actual exposures of workers, the general public and consumers to nanomaterials. Characterize and identify the health outcomes among exposed populations in conjunction with informa

tion about the control strategies used and exposures to determine practices that result in safe levels of ex

posure. RN#1. Understand processes and factors that determine ex

posures to nanomaterials • Conduct studies to understand processes and factors that deter

mine exposure to engineered nanomaterials • Develop exposure classifications of nanomaterials and processes • Develop internationally harmonized and validated protocols for exposure surveys, sample collection and analysis, and reporting through existing and newly created international frameworks • Develop comprehension predictive models for exposures to a broad range of engineered nanomaterials and processes • Characterize process- and task-specific exposure scenarios in the workplace

(continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 43 42 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs RN#2. Identify population groups exposed to engineered nanomaterials • Systematically collect and analyze information about nanomate

rial manufacture, processing, and direct use in commercial and consumer products over time to discern geographic areas where engineered nanomaterials may be emitted into the environment, consumed in the form of ingredients of products, and/or disposed of in solid waste, wastewater, etc. • Conduct population-based surveys to obtain information on use patterns for consumer products • Identify potential subpopulations that are more susceptible to exposure to engineered nanomaterials than others • Develop quantitative assessment methods appropriate for target population groups and conduct assessments of those population groups most likely to be exposed to engineered nanomaterials RN#3. Characterize individual exposures to nanomaterials • Expand currently available exposure assessment techniques to facilitate more accurate exposure assessment for engineered nanomaterials at benchmark concentration levels using feasible methods • Develop new tools through national and international surveys to support effective exposure characterization of individuals • Characterize and detect nanomaterials in biological matrices and conduct studies to understand transformations of nanomaterials during transport in the environment and in human bodies • Conduct studies to examine emissions and human contact during normal use and after wear and tear have degraded a product, as well as during repeated exposures • Develop engineered nanomaterials exposure assessment models based on identified critical exposure descriptions • Develop databases to contain the collected data and information RN#4. Conduct health sur

veillance of exposed popula

tions • Establish a program for the epidemiological investigations of physician case reports and reports of suspicious pattern of adverse events • Establish exposure registry and medical surveillance programs for workers • Analyze injury and illness reporting in existing programs

(continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 43 42 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs 3. Human Health Research Needs Understand the relationship of physico-chemical properties of engineered nanoscale materials to in vivo physico-chemical properties and biological response. Develop high-confidence predictive models of in vivo biological responses and casual physico-chemical properties of ENMs. RN#1. Identify or develop ap

propriate, reliable, and repro

ducible in vitro and in vivo assays and models to predict in vivo human responses to ENMs • Establish a system to develop and apply reliable and reproducible in vitro and in vivo test methods • Evaluate the degree to which an in vitro response correlates with an in vivo response • Evaluate the degree to which in vitro and in vivo models predict human response • Translate structure-activity relationship and other research data into computational models to predict toxicity in silico RN#2. Quantify and charac

terize ENMs in exposure ma

trices and biological matrices • Determine critical ENM measurands in biological and environ

mental matrices and ensure the development of tools to measure ENMs in appropriate matrices as needed • Determine matrix and/or weathering effects that may alter the physico-chemical characteristics of the ENM measurands • Identify key factors that may influence the detection of each mea

surand in a particular matrix (e.g., sample preparation, detection method, storage, temperature, solvents/solutions) • Characterize and quantify exposure for all exposure routes using in vivo models to identify the most likely routes of human exposure • Identify biomarkers of exposure and analytical methods for their determination RN#3. Understand the rela

tionship between the physicochemical properties of ENMs and their transport, distribu

tion, metabolism, excretion, and body burden in the hu

man body • Characterize ENM physico-chemical properties and link to mechanisms of transport and distribution in the human body • Understand the relationship of the physico-chemical properties of ENMs to the mechanisms of sequestration in and translocation of ENMs out of the exposure organ and secondary organs, and to routes of excretion from the human body • Determine the metabolism or biological transformation of ENMs in the human body

(continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 45 44 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs RN#4. Understand the rela

tionship between the physicochemical properties of ENMs and uptake through the human port-of-entry tissues • Characterize ENMs at and in port-of-entry tissues, including nontraditional routes of entry such as the ear and eye, and identify mechanisms of ENM uptake into tissues • Determine the relationship of ENM physico-chemical properties to deposition and uptake under acute exposure conditions and under chronic exposure conditions • Translate data on ENM properties and uptake to knowledge that may be used to intentionally redesign ENMs for optimum human and environmental safety and product efficacy RN#5. Determine the modes of action underlying the human biological response to ENMs at the molecular, cellular, tissue, organ, and whole body levels • Determine the dose response and time course of biological responses at the primary site of exposure and at distal organs fol

lowing ENM exposure • Understand the mechanisms and molecular pathway(s) associated with ENM biology within cellular, organ, and whole organism systems • Link mechanisms of response with ENM physico-chemical prop

erties and employ this information in the design and development of future ENMs • Develop translational alternative in vitro testing methods for the rapid screening of future ENMs based on mechanism(s) of response that are predictive of in vivo biological responses RN#6. Determine the extent to which life stage and/or sus

ceptibility factors modulate health effects associated with exposure to ENMs and nan

otechnology-enabled products and applications • Determine the effect of life stage and/or gender on biological response to ENMs • Establish the role of genetic and epigenetic susceptibility on the biological response to ENMs in the context of life stage and/or susceptibility factors • Understand mechanistically the influence of preexisting disease on the biological response to ENMs in the context of life stage and other susceptibility factors • Identify exposure conditions that make susceptible individuals more vulnerable to the health effects associated with ENMs and nanotechnology-enabled applications • Establish a database that contains published, peer-reviewed litera

ture, occupational and consumer reports, and toxicological profilesthat describe altered responses to ENMs and nanotechnologyenabled applications in susceptible animal models or individuals following exposure

(continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 45 44 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs 4. Environment Research Needs Understand the environmental fate, exposure, and ecological effects of engineered nanomaterials, with priority placed on materials with highest potential for release, exposure, and/or hazard to the environ

ment. RN#1. Understand environ

mental exposures through the identification of principal sources of exposure and expo

sure routes • Manufacturing processes and product incorporation • Life cycle of technology and exposures subsequent to product manufacturing • Analytical approaches to measure temporal changes in nanopar

ticle properties throughout the life cycle • Models to estimate releases • Environmental receptors for exposure assessment RN#2. Determine factors af

fecting the environmental transport of nanomaterials • Determine key physico-chemical properties affecting transport • Determine key transport and fate processes relevant to environ

mental media • Develop new tools and adaptation of current predictive tools to accommodate unique properties of nanomaterials RN#3. Understand the trans

formation of nanomaterials under different environmental conditions • Identify and evaluate nanomaterial properties and transformation processes that will reduce environmental persistence, toxicity, and production of toxic products • Determine the rate of aggregation and long-term stability of agglomeration/aggregation and the long-term stability of these aggregates and agglomerates • Develop tools to predict the transformations or degradability of nanomaterials RN#4. Understand the effects of engineered nanomaterials on individuals of a species and the applicability of testing schemes to measure effects • Test protocols • Dose-response characterization • Uptake/elimination kinetics, tissue/organ distribution • Mode/mechanism of action, predictive tools • Tiered testing schemes/environmental realism RN#5. Evaluate the effects of engineered nanomaterials at the population, community, and ecosystem levels • Population • Community • Other ecosystem-level effects • Predictive tools for population-, community-, and ecosystem-level effects (continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 47 46 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs 5. Risk Assessment and Risk Management Methods Research Needs Increase available information for better decision making in assessing and managing risks from nanoma

terials, including using comparative risk assessment and decision analysis; life cycle considerations; and additional perspectives such as ELSI considerations, stakeholders’ values, and additional decision makers’ considerations. RN#1. Incorporate relevant risk characterization informa

tion, hazard identification, ex

posure science, and risk mod

eling and methods into the safety evaluation of nanoma

terials • Characterization, fate, and release of nanoparticles throughout the life cycles of nanotechnology-enabled products • Development of predictive models on accumulation, migration, and release of nanoparticles throughout the life cycles of nano

technology-enabled products • Safety of nanoparticles throughout the life cycles of the nanotech

nology-enabled products • Comprehensive and predictive models to assess the potential risks of nanoparticles during the manufacturing and life cycle of nano

products, with inputs from human and environment exposures and on nanomaterial properties RN#2. Understand, character

ize, and control workplace ex

posures to nanomaterials • Dissemination and implementation of effective techniques and protocols to measure exposures in the workplace • Identification and demonstration of effective containment and control technologies including for accidents and spills • Development of an effective industry surveillance system • Design and deployment of a prospective epidemiological frame

work relevant to exposure science • Systematic approaches for occupational risk modeling RN#3. Integrate life cycle con

siderations into risk assessment • Establishment of nanotechnology-specific taxonomy for life cycle stages • Integration of risk assessment, life cycle analyses, and decisionmaking approaches into regulatory decision making processes • Application of adaptive management tools based on monitoring/ implementation to evaluate life cycle analysis implementation • Development of case studies, e.g., green chemistry, nanomaterials selection, nanomaterials acquisition process, illustrating applica

tion of these risk management methods

(continued) Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 47 46 | Protecting the Nanotechnology Workforce Key Research Needs Subordinate Research Needs RN#4. Integrate risk assess

ment into decision-making frameworks for risk manage

ment • Development of comparative risk assessment and formal decisionanalytical methods as opposed to “absolute” risk assessment strate

gies • Application of formal decision-analytical methods to prioritize risk management alternatives • Use of gap analyses and value of information analysis to identify research needs • Integration of stakeholder values and risk perceptions into risk management processes • Application of integrated decision framework through case studies in risk management decision making RN#5. Integrate and standard

ize risk communication with

in the risk management frame

work • Development and use of standardized terminology in risk communications • Early information-sharing on hazards and risk among Federal agencies • Development of appropriate risk communication approaches for agency-specific needs Informatics and Modeling Research Need RN#1. Develop computation

al models of ENM structureproperty-activity relationships to support the design and de

velopment of ENM with max

imum benefit and minimum risk to humans and the envi

ronment • Validate the predictive capability of in vitro and in vivo assays and employ that subset of assays in data generation to establish computational models to predict ENM behavior in humans and the environment • Establish a standard set of physical and chemical characterization parameters, dose metrics, and biological response metrics • Design and establish structures and ontologies for methods devel

opment, data capture, sharing, and analysis • Evaluate and adapt as necessary existing computational models by beginning with existing models for exposure and dosimetry and using data generated from validated assays • Use ENM exposure and dosimetry models to develop ENM structure-activity models to predict ENM behavior in humans and the environment • Establish training sets and beta test sites to refine and validate ENM structure-activity models • Disseminate ENM structure-activity models through publicly ac

cessible nanotechnology websites Table D–1 (Continued). The Core EHS Research Categories and their Highest-Priority Research Needs (RNs)Protecting the Nanotechnology Workforce | 49 

# APPENDIX B Timeline for NIOSH Nanotechnology Research
Summary of Proposed Research Projects, FY2013–FY2014 Critical research area Projects Toxicity and Internal Dose Evaluate long-term fibrogenic and carcinogenic potential of carbon nano

tubes and carbon nanofibers. Determine immune and cardiovascular responses to pulmonary exposure to CNT, TiO 2 , and nanosilver. Evaluate the pulmonary effects of nanosilver. Measurement Methods Develop updated methods and approaches to assess occupational expo

sures to nanomaterials. Utilize reference materials and technically sound protocols to improve measurement quality. Develop techniques to characterize nanoparticles, using advanced micros

copy methods. Study the performance of direct reading instruments for assessing emis

sions and exposure to nanoparticles in the workplace. Exposure Assessment Complete evaluation of workplace exposures to emerging, secondgeneration, and third-generation ENMs and their potential routes of exposure. Complete evaluation of size, concentration, and morphology of ENMs emitted by various processes. Epidemiology and Surveillance Evaluate occupational exposures among carbonaceous nanomaterial workers. Complete field work for a cross-sectional epidemiologic survey among workers exposed to carbonaceous nanomaterials. Collect data on specific biomarkers as markers of exposure or early health endpoints in workers exposed to carbon nanotubes or carbon nanofibers. (continued)50 | Protecting the Nanotechnology Workforce Critical research area Projects Risk Assessment Develop a strategy and criteria to utilize the best available scientific data to develop hazard- and risk-based occupational exposure limits and other risk management guidance. Identify nanomaterial categories by physicochemical properties and bio

logical mode of action, and perform case study evaluations for nanomate

rials within each major category. Analyze toxicity data, including identifying the adverse health endpoint(s) and performing dose-response analyses and/or comparative potency analyses. Contribute to the development and evaluation of dosimetry models and methods to assess internal dose of nanomaterials in workers. Engineering Controls and PPE Conduct field studies to assess and improve engineering control strategies in the workplace. Evaluate effectiveness of commercially available engineering controls in the laboratory. Finalize development of a standardized aerosol test method using mag

netic passive aerosol samplers for testing of protective clothing material. Expand particulate penetration project to include evaluation of different types of fabrics, use of electrostatic charges, and bellows effects. Evaluate balance between comfort and protection of protective clothing and gloves with ENMs. Fire and Explosion Safety Evaluate nano metals and other ENMs for fire and explosion potential. Evaluate a variety of ENMs for electromagnetic hazard potential. Correlate dustiness of ENMs with various physical and chemical safety hazards. Evaluate current DOT and NFPA guidance for adequacy with ENMs. Provide recommendations to first responders about safety issues of ENMs. Recommendations and Guidance Continue conducting r2p activities (ongoing), such as developing bro

chures and fact sheets and updating the topic page. Develop a small business guide for nanomaterial producers and users. Summary of Proposed Research Projects, FY2013–FY2014



### (continued)Protecting the Nanotechnology Workforce | 51 Critical research area Projects Applications Further develop and refine end-of-service indicators using nanomaterials. Global Activities Strengthen participation with globally recognized organizations ICON, ISO, OECD, and UN (WHO, ILO). Participate in the US/EU nanomaterial working groups hosted by the NNI. Summary of Proposed Research Projects, FY2013–FY201452 | Protecting the Nanotechnology Workforce Summary of Proposed Research Projects for FY2015–FY2016 Critical research area Projects Toxicity and Internal Dose Identify biomarkers of response to ENMs. Develop predictive algorithms for relationships between nanoparticle properties and bioactivity. Determine the relevance of in vitro and in vivo screening tests. Evaluate the pulmonary and systemic effects of graphene and nanocellu

lose. Measurement Methods Publish updated exposure measurement methods. Assist with round-robin evaluations of ENM reference materials. Exposure Assessment Publish exposure results. Provide guidance on exposure assessment methods and sampling proto

cols. Epidemiology and Surveillance Analyze biomarker samples from cross-sectional epidemiologic study of carbon nanotube and nanofiber workers. Analyze data (medical and biomarker with exposure) from cross-sectional epidemiologic study of carbon nanotube and nanofiber workers. Begin collecting data for exposure registry and prospective epidemiolog

ic study among carbon nanotube–exposed and carbon nanofiber–exposed workers. Assess feasibility of epidemiologic study of health outcomes among work

ers exposed to nanomaterials other than carbonaceous nanomaterials. Risk Assessment Extend evaluations of the hazard and risk of workplace exposure to new nanomaterials. Utilize the latest data from toxicity studies, workplace exposure measure

ments, and/or biomonitoring data to identify potential hazards in the re

spiratory tract and/or other organs. Contribute to the refinement and validation of dosimetry models for nanomaterials. Contribute to the evaluation and development or updating of recom

mended exposure limits and other risk management guidance.

(continued)Protecting the Nanotechnology Workforce | 53 Critical research area Projects Engineering Controls and PPE Continue to assess engineering controls in the field and update recom

mendations for controlling exposure. Continue to evaluate commercially available engineering controls in the lab and publish test results. Evaluate respirator performance with ENMs in laboratory and workplace settings. Develop a passive method for measuring particle penetration through protective clothing materials. Fire & Explosion Safety Continue evaluation of various ENMs for fire and explosion potential. Evaluate a variety of ENMs for electromagnetic hazard potential. Correlate dustiness of ENMs with various physical and chemical safety hazards. Publish findings in journals and provide summaries to DOT and NFPA. Recommendations and Guidance Update Approaches to Safe Nanotechnology Develop hazard bands and RELs for high-volume commercially available ENMs. Applications Evaluate ENM-enabled PPE. Global Activities Lead or co-lead committees with globally recognized organizations: ICON, ISO, OECD, and UN (WHO, ILO). NOTE: DOT, Department of Transportation; ENMs, engineered nanomaterials; ICON, International Council on Nanotechnology; ILO, International Labour Organization; ISO, International Organization for Standardization; NFPA, National Fire Protection Association; NNI, National Nanotechnology Initiative; OECD, Organization for Economic Cooperation and Development; PPE, personal protective equipment; UN, United Nations; WHO, World Health Organization. Summary of Proposed Research Projects for FY2015–FY2016 (Continued)

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