DRAFT: For review purposes only. Do not cite or quote. 
DRAFT: For review purposes only. Do not cite or quote. 

Protecting the Nanotechnology Work 

Force: A Strategic Plan for the NIOSH 

Nanotechnology Research Center,

FY2013–FY2016

DRAFT December 2012

Disclaimer

Mention of any company or product does not constitute endorsement by the National Institute 

for Occupational Safety and Health (NIOSH). In addition, citations to Web sites external to 

NIOSH do not constitute NIOSH endorsement of the sponsoring organizations or their programs 

or products. Furthermore, NIOSH is not responsible for the content of these Web sites. All Web 

addresses referenced in this document were accessible as of the publication date.

Ordering Information

To receive documents or other information about occupational safety and health topics, 

contact NIOSH at

Telephone: 1–800–CDC–INFO (1–800–232–4636)

TTY: 1–888–232–6348

E-mail: cdcinfo@cdc.gov

or visit the NIOSH Web site at www.cdc.gov/niosh.

For a monthly update on news at NIOSH, subscribe to NIOSH eNews by visiting

www.cdc.gov/niosh/eNews.

DHHS (NIOSH) Publication No. 2013–XXX

December 2012

Safer • Healthier • PeopleTM
DRAFT: For review purposes only. Do not cite or quote. 

Foreword

The National Institute for Occupational Safety and Health (NIOSH) is pleased to present the Strategic 

Plan for the NIOSH Nanotechnology Research Center, FY2013–FY2016. 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 is a comprehensive plan managed as a matrix structure across NIOSH and supports 

multiple sectors in the National Occupational 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 

realized 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 promoting 

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

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 Strategic Plan for the NIOSH Nanotechnology Research Center is the roadmap being used to 

advance the basic understanding of the toxicology and workplace exposures involved so that 

appropriate risk management practices can be implemented during discovery, development, and 

commercialization of engineered nanomaterials. NIOSH will strive to remain at the forefront of 

promoting the safe and responsible development of such a promising technology. 
DRAFT: For review purposes only. Do not cite or quote. 

Table of Contents

Foreword ....................................................................................................................... i

Executive Summary ..............................................................................................................1

1.Introduction....................................................................................................................... 4

1.1 Background................................................................................................................... 4

1.2 Mission of NIOSH.......................................................................................................... 5

1.3 NIOSH Logic Model..................................................................................................... 7

2.Inputs............................................................................................................................... 10

2.1 Nature of Nanomaterials............................................................................................. 10

2.2 Nature of Nanomaterial Workplace ............................................................................ 10

2.3 Customers’ and Stakeholders’ Input........................................................................... 11

2.4 NIOSH Research Capabilities..................................................................................... 12

2.5 NIOSH Partnerships.................................................................................................... 13

3.Activities......................................................................................................................... 14

3.1 NIOSH Nanotechnology Research Center (NTRC) .................................................. 14

3.2 NTRC Steering Committee......................................................................................... 15

3.3 Current NIOSH Intramural Nanotechnology Research Activities.............................. 15

3.4 Current NIOSH Extramural Nanotechnology Research Activities ............................ 16

4.Goals............................................................................................................................... 17

4.1. NTRC: Address Each Element in the Risk Management Continuum........................ 17

4.2 NTRC Data Needs ...................................................................................................... 19

4.3 Coalescing Priorities for FY2013–FY2016 ................................................................ 21

4.4 Coordination with National Nanotechnology Initiative ............................................. 23

4.5 Strategic Goals, Intermediate Goals, and Activity/Output Goals............................... 25
DRAFT: For review purposes only. Do not cite or quote. 

5.Outputs............................................................................................................................ 36

5.1 NIOSH Publications on Nanotechnology Since 2009 ................................................ 36

5.2 NIOSH Peer-reviewed Publications ........................................................................... 37

5.3 Sponsored Conferences............................................................................................... 37

5.4 Presentations............................................................................................................... 38

6.Research to Practice ........................................................................................................ 38

6.1 Capacity Building through Technical Assistance ....................................................... 38

7.Intermediate Customers and Intermediate Outcomes..................................................... 39

7.1 Federal Government Agencies.................................................................................... 39

7.2 Standards Development Organizations....................................................................... 39

7.3 Industry, Labor, and Academia................................................................................... 39

7.4 Professional Organizations ......................................................................................... 40

7.5 Research Collaborations ............................................................................................. 40

7.6 International Activities................................................................................................ 40

8.Outcomes ........................................................................................................................ 41

References ......................................................................................................................... 42

Appendix A. NNI Environmental, Health, and Safety Research Strategy Needs.................... 44

Appendix B. Timeline for NIOSH Nanotechnology Research............................................... 52
P a g e | 1

DRAFT: For review purposes only. Do not cite or quote. 

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 manufacture of 

nanomaterial-based products, of which 2 million may be manufactured in the United States. 

Nanomaterials may present new challenges to understanding, predicting, and managing potential 

health risks to workers.

Many knowledge gaps still remain on how to work safely with all of these materials. Through 

strategic planning, research, partnering with stakeholders, and making information widely available, 

NIOSH is working to continue to provide national and world leadership in preventing work-related 

illness and injury.

NANOTECHNOLOGY AND NIOSH RESEARCH

Nanotechnology and the commercialization of products and devices containing engineered 

nanomaterials 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 realized if cautions about the adverse effects are not heeded and concerns are not 

honored. Timely targeted research is needed to define risks and 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 transparent and credible process that coincides

with development of this new technology. NIOSH is playing an active part in this process by

supporting the development of a broad spectrum of research and prevention strategies related to 

nanotechnology. In a series of reports [NIOSH 2007, 2010, 2012], NIOSH has reported on its 

progress in conducting nanotechnology 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; and 

provided guidance on control technologies, medical surveillance, and epidemiologic research. There 

are many questions still to be answered. A vast number of potential nanomaterials can result from the 

combination of a broad range of physicochemical factors. There is need for an expeditious approach to 
P a g e | 2

DRAFT: For review purposes only. Do not cite or quote. 

control exposure to the large number of nanomaterials in science and commerce now and in the future.

Moreover, the nanomaterials under development now are likely to have additional potentially 

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

NIOSH NANOTECHNOLOGY RESEARCH CENTER (NTRC)

NIOSH established the NIOSH Nanotechnology Research Center (NTRC) in 2004 to coordinate

nanotechnology research across the Institute. The NTRC and its steering committee of critical area 

coordinators are responsible for developing and guiding NIOSH scientific and organizational plans in 

nanotechnology health and safety research.

STRATEGIC PLAN

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

numerous nanomaterials are in commerce. Nanotechnology has the potential to provide great 

benefit to society, but it must be developed responsibly. This responsibility involves addressing 

adverse human and environmental impacts of the technology. Workers are among the first people 

in any society to be exposed to the products of new technology, and their exposure is often 

greater than for the general population. Therefore, worker safety and health can be seen as the 

core of responsible development (Figure 1).

In the coming 3 years, NIOSH will marshal its resources and partner with others efficiently and 

effectively to advance efforts for the protection of the nanotechnology workforce. With the input 

of a broad range of stakeholders in government, academia, and the private sector, NIOSH has 

operated under a strategic plan for nanotechnology research and guidance. The most recent 

version was published in November 2009 and included research plans through FY12 

(see http://www.cdc.gov/niosh/docs/2010-105/).
P a g e | 3

DRAFT: For review purposes only. Do not cite or quote. 

Figure 1. The core of responsible development of nanotechnology.

This document presents the NTRC Strategic Plan for FY2013–FY2016. The strategic plan also 

highlights how NIOSH’s critical research and guidance efforts align with and support the 

National Nanotechnology Initiative’s comprehensive Environmental, Health, and Safety 

Research Strategy needs. 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 on 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 nonmaterial workers, including medical and exposure 

studies. 

5. Assess and promote national adherence with risk management guidance. 

To address the strategic goals and promote the responsible development of engineered 

nanomaterials, the strategic plan will expand research activities in 10 NTRC critical areas: (1) 

toxicity and internal dose, (2) measurement methods, (3) exposure assessment, (4) epidemiology 
P a g e | 4

DRAFT: For review purposes only. Do not cite or quote. 

and surveillance, (5) risk assessment, (6) engineering controls and personal protective equipment 

(PPE), (7) fire and explosion safety, (8) recommendations and guidance, (9) global 

collaborations, and (10) applications.

1 INTRODUCTION

1.1 Background

Nanotechnology is a system of innovative methods to control and manipulate matter at near-atomic 

scale to produce new materials, structures, and devices. Nanoparticles are a specific class or subset of 

these new materials, having three dimensions that are less than 100 nanometers. Nano-objects, a 

subset of nanoparticles, have at least one dimension less than 100 nanometers [ISO 2008]. 

Nanoparticles exhibit unique properties because of their nanoscale dimensions. Nanotechnology offers 

the potential for tremendous improvement and advances in the development of commercial products

that may benefit society, such as integrated sensors, semiconductors, medical imaging, drug delivery 

systems, structural materials, sunscreens, cosmetics, and coatings. Nanotechnology is one of the most 

rapidly growing industries across the world. By 2020, the global market for nanotechnology-related 

products is predicted to reach $3 trillion and employ 2 million workers in the United States alone

[NSF 2011]. A review of the 2012 version of the Nanowerk nanomaterials database revealed over 

2,600 commercially available nanomaterials (http://www.nanowerk.com/phpscripts/n_dbsearch.php).

The properties of engineered nanoparticles (e.g., size, surface area, reactivity) that yield many 

improvements in commercial products may also pose health risks. Currently, increasing numbers of 

workers are potentially exposed to nanomaterials in research laboratories, start-up companies, 

production facilities, and operations where nanomaterials are processed, used, disposed, or recycled. 

The challenges are to determine whether the nature of intentionally produced (engineered)

nanostructured materials and devices presents new occupational safety and health risks. At the same 

time, there is a need to address how the benefits of nanotechnology can be realized while proactively 

minimizing the risk.

Efforts across multiple federal agencies 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 
P a g e | 5

DRAFT: For review purposes only. Do not cite or quote. 

National Nanotechnology Initiative (NNI) [NNI 2001]. This initiative supports basic and applied 

research in nanotechnology to create new nanomaterials and to disseminate new technical capabilities 

to industry. The purpose of the NNI is to facilitate scientific breakthroughs and maintain U.S. 

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

nanotechnology research leads to the responsible development of beneficial applications by giving 

high priority to research on societal implications, human health, and environmental issues related to 

nanotechnology.

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 declared that the 

intent of these acts was to assure, 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 recommending occupational safety and health standards and defining exposure

levels that are safe for various periods of employment. These include (but are not limited to) the 

exposures at which no worker will suffer diminished health, functional capacity, or life expectancy as 

a result of his or her work experience. By means of criteria documents and other publications, NIOSH 

communicates these recommended standards to the Occupational Safety and Health Administration 

(OSHA), the Mine Safety and Health Administration (MSHA), and others in the occupational safety 

and health community.

Under the OSH Act, NIOSH is charged with conducting “research, experiments, and demonstrations 

relating to occupational safety and health” and with developing “innovative methods, techniques, and 

approaches for dealing with [those] problems.” The act specifies target areas of research that include 

identifying criteria 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 

conducting training and education “to provide an adequate supply of qualified personnel to carry out 

the purposes of the Act” and for assisting employers and workers with applying methods to prevent 

occupational injuries and illness (Section 21 of the OSH Act).

NIOSH has over 40 years of experience in conducting research and formulating recommendations for 

occupational safety and health. During this period, NIOSH has developed considerable expertise in 
P a g e | 6

DRAFT: For review purposes only. Do not cite or quote. 

measuring, characterizing, and evaluating new processes and new materials by conducting 

quantitative exposure assessments and evaluating health effects. NIOSH also has expertise in 

developing exposure control systems and prevention strategies as well as experience in conducting

risk assessments and recommending effective risk management practices.

In 2003, NIOSH became a member of the Nanoscale Science, Engineering, and Technology 

(NSET) Subcommittee of the National Science and Technology Council. As a member, NIOSH 

participates in (1) identifying critical issues related to possible hazards of nanomaterials, (2) 

protecting worker safety and health in this emerging technology, and (3) developing a strategic 

plan to address such issues and recommend prevention strategies for the safe handling and use of 

nanomaterials. 

In 2004, NIOSH created the Nanotechnology Research Center (NTRC) to identify critical issues, 

create a strategic plan for investigating these issues, coordinate the NIOSH research effort, 

develop research partnerships, and disseminate information gained. The NTRC comprises

nanotechnology-related activities and projects involving and supported by approximately 50 

scientists in various NIOSH divisions and laboratories. Through the NTRC, NIOSH has 

identified 10 critical research areas for nanotechnology research and communication. These 10

critical research areas, updated for FY2013–FY2016, are (1) toxicity and internal dose, (2) 

measurement methods, (3) exposure assessment, (4) epidemiology and surveillance, (5) risk 

assessment, (6) engineering controls and personal protective equipment (PPE), (7) fire and 

explosion safety, (8) recommendations and guidance, (9) global collaborations, and (10)

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 workers and responsibly move nanotechnology forward so that its farreaching benefits may be realized.

The NIOSH NTRC is working strategically to fill nanomaterial occupational safety and health 

knowledge gaps through active intramural and extramural research programs and collaborations.

Extramural research is carried out through the NIOSH Office of Extramural Programs (OEP), in 

which nanotechnology research (R01, R21, R43/44) is funded to increase the knowledge of 
P a g e | 7

DRAFT: For review purposes only. Do not cite or quote. 

nanotechnology and engineered nanomaterials as they relate 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 engineered nanomaterials, and the use of 

nanotechnology for the development of sensors. NIOSH is committed to conducting and supporting 

studies that will improve scientists’ abilities to identify potential occupational health effects of 

nanomaterials. NIOSH will facilitate the translation of those findings into effective workplace 

practices. 

The NIOSH NTRC continues to be part of the U.S. leadership on the International Organization for 

Standardization (ISO) TC 229 Nanotechnology Working Group on Health, Safety, and the 

Environment and continues to work with the World Health Organization collaborating centers on 

global projects of information dissemination and communication. Through these collaborations the 

NIOSH NTRC assists in developing risk communications on the safe handling of nanomaterials.

1.3 NIOSH Logic Model

NIOSH receives input on identifying and addressing occupational safety and health problems through 

a process (i.e., a logic model) in which the seriousness of the problem or hazard 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 2) has a conventional horseshoe 

shape, with the operational upper branch proceeding from inputs to outcomes and with the strategic 

lower branch proceeding from strategic goals to management objectives. Both branches are correlated 

vertically and are subject to external factors. 
P a g e | 8

DRAFT: For review purposes only. Do not cite or quote. 

Figure 2. Schematic of the overall NIOSH logic model.

The NIOSH operational model (Figure 3) for conducting research adheres to the logic model by 

acquiring and analyzing inputs from customers/stakeholders (production inputs) and internal/external 

research capabilities (planning inputs) to determine and prioritize research. Intramural and extramural 

researchers present their project proposals, which receive appropriate internal and external review and 

are funded on the basis of merit. The conduct of research (activities) produces “outputs” such as 

guidance documents and reports that address effective 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 implement improvements 

in workplace safety and health) or to intermediate customers (who utilize NIOSH outputs to produce 

intermediate outcomes). These intermediate outcomes, such as training programs, regulations, and 

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

regulatory agency, it relies heavily on efforts by intermediate and final customers to achieve ultimate 

outcomes in the form of workplace safety and health improvements. The effectiveness in achieving 

these outcomes is influenced at all stages of the program operation by both external factors (such as 

economic and social conditions) and the regulatory environment. Results of NIOSH-funded research 

and customer feedback (intermediate and final outcomes) contribute to the subsequent rounds of 

program planning. 

Inputs Activities Outputs Customers Outcomes

Operations

Intermediate 

Goals

Mission

Strategic 

Goals

Strategy and design

Annual 

Goals

Management 

Objectives

External factors
P a g e | 9

DRAFT: For review purposes only. Do not cite or quote. 

Figure 3. Schematic of the NIOSH operational model.
P a g e | 10

DRAFT: For review purposes only. Do not cite or quote. 

2 INPUTS

2.1 Nature of Nanomaterials

The universe of nanomaterials is potentially large because of the array of possible combinations 

of physicochemical parameters, impurities, and manufacturing and production conditions (Figure 

4). NIOSH recognizes the extensive diversity and number of nanomaterials and continues to use 

approaches that allow for a holistic view of nanomaterials and development of priorities that will 

be beneficial to many workers.

Figure 4. The wide variety of engineered nanomaterial physicochemical parameters [Schulte et 

al. 2009].

2.2 Nature of the Nanomaterial Workplace

Worker exposure to nanomaterials may occur along the lifecycle of the nanomaterial, from 

research through scale-up, manufacturing, product development, use, and end of life (Figure 5). 

Each of the functional areas represents workplaces with different potential exposure scenarios 

and risks. NIOSH continues to focus on the wide array of workplaces where exposure to 

nanomaterials may occur. 
P a g e | 11

DRAFT: For review purposes only. Do not cite or quote. 

Figure 5. The lifecycle of nanomaterials.

2.3 Customer and Stakeholders’ Input

To fulfill its responsibilities under the OSH Act and the FMSH Act, NIOSH has relied on input from 

OSHA and MSHA, workers, employers, trade associations, unions, occupational safety and health 

practitioners and researchers, and the general public for directing its research activities. NIOSH also 

seeksinput through formal committees such asthe NIOSH Board of Scientific Counselors, the National 

Advisory Committee on Occupational Safety and Health, and the Mine Safety and Health Research 

Advisory Committee and through ad hoc mechanisms such as the NIOSH Web site 

(www.cdc.gov/niosh), the NIOSH toll-free telephone line (1-800-CDC-INFO), personal contacts with 

occupational safety and health professionals, and participation in professional conferences and 

interagency committees. In addition, NIOSH provides stewardship of the National Occupational 

Research Agenda (NORA) (http://www.cdc.gov/niosh/nora), which is a framework to guide 

occupational safety and health research into the new millennium—not only for NIOSH but for the entire 

occupational safety and health community.
P a g e | 12

DRAFT: For review purposes only. Do not cite or quote. 

NIOSH continues to be a partner in the National Nanotechnology Initiative (NNI) and provides 

occupational health and safety expertise in support of the U.S. Government’s Strategic Plan for 

Nanotechnology Health and Safety Research. NIOSH is co-leader of the NNI Nanotechnology 

Environmental and Health Implications Working Group (NEHI) and contributed to the 

development of the 2011 NEHI Environmental, Health, and Safety (EHS) Research Strategy.

The 2011 NEHI EHS research strategy identified five core nanotechnology EHS research 

categories: (1) nanomaterial measurement infrastructure, (2) human exposure assessment, (3) human 

health, (4) environment, and (5) risk assessment and management methods (Appendix A) [NNI 2011].

NIOSH provided significant input for the strategy and was the lead agency 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 also fostering the technological advancements that benefit society. The 

overarching research activities of the NIOSH NTRC nanotechnology strategic plan (Section 4.3)

have strived to be consistent with the NNI EHS research strategy.

The NIOSH NTRC also fosters stakeholder input with trade associations, professional associations, labor, nongovernmental organizations, and a number of private nanomaterial companies. 

These collaborations have provided expertise 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 Hygiene Association 

(AIHA), American Society of Safety Engineers (ASSE), International Safety Equipment Association, National Safety Council (NSC), American Federation of Labor and Congress of Industrial 

Organizations (AFL–CIO), and the Nanobusiness Commercialization Association.

2.4 NIOSH Research Capabilities

The world-class research capability of NIOSH is an integral part of management’s inputs for the 

nanotechnology program. Within its Divisions, NIOSH has world-renowned researchers who are 

trained and experienced 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 

expertise, NIOSH has significant laboratory capabilities in particle measurement, aerosol collection 

and characterization, particle surface analysis, measurement of particle surface radicals and activity, 
P a g e | 13

DRAFT: For review purposes only. Do not cite or quote. 

and in vitro and in vivo analysis of toxicity and pathogenesis. Laboratories conducting nanomaterial 

research are located in Cincinnati, Ohio; Pittsburgh, Pennsylvania; and Morgantown, West Virginia. 

NIOSH researchers work closely with a broad range of scientists from industry, academia, and other 

government agencies. NIOSH involvement in national and international initiatives 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, 

federal agencies, and nongovernmental organizations. 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 nanotechnology. Partnerships have taken several forms, ranging 

from formal letters or memoranda of understanding 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 effective vehicles to develop and disseminate research results.

The NIOSH NTRC has successfully used partnerships with industry to gain a better 

understanding of actual industrial nanomaterial processes, workplace exposures, work practices, 

and exposure control techniques. The field research conducted by the NTRC to assess exposures 

to engineered nanoparticles represents ongoing partnerships with numerous companies. The 

NTRC will continue to develop these partnerships to (1) better understand how engineered 

nanoparticles are being produced and used, (2) develop recommendations for the safe handling 

of nanomaterials, (3) develop sampling and analytical methods, (4) evaluate exposure controls 

that are or could be used in nanomaterial processes, (5) evaluate the need for and determine the 

effectiveness of PPE, including respiratory protection, and (6) develop communication and 

information materials that will assist industry in communicating with workers and the public. 

Several of the industrial partnerships have provided opportunities for the NTRC to identify areas 

where additional research is needed. 
P a g e | 14

DRAFT: For review purposes only. Do not cite or quote. 

The continued collaboration with other national and international research institutes, academia,

and government agencies provides the NTRC the opportunity to combine its expertise in 

workplace health and safety with the capabilities of other organizations to investigate specific 

areas of concern. Working relationships with other research institutes provide the NTRC with the 

information needed to guide its own research, focus its limited resources in the most effective 

manner, and expand its research capabilities through scientific collaboration. The NTRC has 

developed partnerships in the areas of toxicology, risk assessment modeling, exposure 

measurement methods, epidemiology, industrial hygiene, control technologies, filtration 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 committees 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. 

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 Nation’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 national and world leadership for research and guidance into 

the implications of nanoparticles and nanomaterials for work-related injury and illness, and the 

application of nanoparticles and nanomaterials in occupational safety and health.
P a g e | 15

DRAFT: For review purposes only. Do not cite or quote. 

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 coordinator, 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 guiding NIOSH scientific and organizational plans in nanotechnology 

research (including coordination for science and budget) and for developing strategic goals and 

objectives and performance measures for the NTRC. Regular updates and progress reporting on 

internal research activities is managed through biweekly teleconferences among members of the 

NTRC steering committee. In addition, to ensure the responsiveness, relevance, and impact of 

NIOSH’s nanotechnology program, members of the NTRC and appropriate 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 engineered nanomaterials. Data gathered from ongoing 

research studies with engineered nanoparticles are used to better understand workplace nanoparticle 

exposures, 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 nanomaterials 

produced and used in the workplace, routes of exposure, and the effectiveness of work practices and 

engineering controls in preventing worker exposure. Findings from these intramural studies are

providing scientific data to support the development of occupational safety and health 

recommendations. NIOSH progress and accomplishments in nanotechnology research can be found in 

the report Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report 

from the NIOSH Nanotechnology Research Center, 2004–2011 [NIOSH 2012].

3.3.1 Evaluation of the nanotechnology research program

NIOSH evaluates its research progress in nanotechnology through a series of internal and 

external reviews. Past reviews of its nanotechnology research program have been conducted by

the National Academies and by work group of scientists chaired by two members of the NIOSH 
P a g e | 16

DRAFT: For review purposes only. Do not cite or quote. 

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) identifying categories of 

nanomaterials that can be distinguished by their physical and chemical properties, (2) 

recommending specific exposure limits for various nanomaterials, (3) assessing hazards, risks, 

and exposures, and (4) developing intervention strategies [NIOSH 2009]. In addition to external 

reviews, NIOSH continues to conduct annual program reviews and regular project reviews, and 

it publishes periodic progress reports describing ongoing research and accomplishments.

3.4 Current NIOSH Extramural Nanotechnology Research Activities

The NIOSH Office of Extramural Programs (OEP) manages the competitive process for 

awarding occupational safety and health grants and cooperative agreements to the research 

community outside the Institute. This process involves peer review, program relevance, and 

priorities of the National Occupational Research Agenda (NORA), the NIOSH Research to 

Practice (r2p) initiative, 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 funded nanotechnology research through Occupational Safety 

and Health Research Program Announcements (R01) and Small Business Innovation Research 

Grants (R43/44). During the period 2001 to 2012, the NIOSH OEP has committed approximately

$12 million to extramural nanotechnology research.

1

Summaries of the projects funded by the 

NIOSH OEP are included in the document Filling the Knowledge Gaps for Safe Nanotechnology 

in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004–

2011 [NIOSH 2012]. Through continued collaboration with the Environmental Protection 

Agency/National Center for Environmental Research (EPA/NCER), National Science 

Foundation (NSF), National Institutes of Health/National Institute of Environmental Health 

Sciences (NIH/NIEHS), and international agencies, the NIOSH OEP continues to support 

nanotechnology research that focuses on occupational safety and health issues. In addition, the 

NIOSH OEP routinely confers with the NIOSH NTRC regarding research needs.

 

1This includes all extramural projects that include any aspect of nanotechnology.
P a g e | 17

DRAFT: For review purposes only. Do not cite or quote. 

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 protect the 

nanotechnology workforce. It is relatively early in the emergence of nanotechnology and there are 

many gaps in knowledge, yet nano-enabled products are in commerce and workers are being exposed 

to nanomaterials. Consequently, there is need to address each element in the risk management 

continuum.

The process for managing potential workplace exposures to engineered nanoparticles during their 

synthesis and incorporation into new materials and devices consists of the following steps to ascertain 

the appropriate risk management strategy: 1) identifying and characterizing the hazard, 2) conducting 

dose-response risk assessment, 3) assessing the extent of exposure, 4) characterizing the risk based on 

exposure, and 4) developing control and management procedures [Schulte et al. 2008]. As exposure 

assessment data for nanomaterials become available, a determination can be made as to whether an 

occupational risk exists, and if so, under what conditions would exposure to the hazard be harmful to 

workers. A goal of the risk characterization is to determine whether exposure to a given technology or 

type of material (in this case, nanomaterials) is likely to result in adverse health effects. Exposure 

assessment data provide a means to determine whether workers might be exposed and what type of 

control strategy might be effective in preventing exposure. The NIOSH NTRC is involved in 

conducting research and answering questions posed in each element of the risk management process 

to address existing knowledge gaps in the protection of workers (Figure 6).
P a g e | 18

DRAFT: For review purposes only. Do not cite or quote. 

Figure 6. Addressing knowledge gaps in protecting nanomaterial workers.

A challenge of the NIOSH NTRC program is to determine how to conduct timely research that 

addresses the elements of hazard identification through risk management as nanomaterials continue to 

be introduced into the workplace and the workforce exposed to these materials becomes more 

diversified. The approach taken by the NTRC has been to conduct focused research to address 

knowledge gaps in each step of the risk management process to provide occupational safety and health 

guidance.
P a g e | 19

DRAFT: For review purposes only. Do not cite or quote. 

4.2 NTRC Data Needs for Knowledge Gaps

The NTRC steering committee met in spring 2012 to identify data needs and research gaps.

Information was gleaned from (1) research studies conducted by the NIOSH NTRC and others; (2) 

comments received during public review from open meetings or submitted to the NIOSH Docket on 

Interim Guidance for Medical Screening and Hazard Surveillance for Workers Potentially Exposed to 

Engineered Nanoparticles; (3) comments received during public review from open meetings or

submitted to the NIOSH Docket on Current Intelligence Bulletin for Occupational Exposure to 

Carbon Nanotubes and Nanofibers; (4) comments received in the Docket on the draft strategic goals

[76 Fed. Reg.2123612]; (5) the 2011 NEHI Environmental, Health, and Safety (EHS) Research 

Strategy; and (6) various scientific meetings and collaborations including tripartite attendance (labor, 

industry, and government). Based on this information, the following data needs and research gaps 

have been identified:

Identify new hazards and related health risks to workers

 Identify emerging commercial engineered nanomaterials (ENMs) through market forecasting 

and research, technology surveillance, and partner and stakeholder input.

 Determine how workers might be exposed to nanoparticles during manufacturing and 

handling of nanomaterials.

o Expand research from primary manufacturer to second-, third-, and fourth-generation use 

of ENMs.

o Continue field investigations to better understand worker exposures through the lifecycle,

including processing of nano-enabled products.

 Determine how engineered nanomaterials interact with the body’s systems.

 Determine relationships between specific physicochemical properties of ENMs and adverse 

biological effects.

 Demonstrate effective risk mitigation practices

Increase understanding of the initial hazard findings

 Determine carcinogenicity of carbon nanotubes (CNTs).

 Determine whether the cardiovascular system is more sensitive than the lung to effects from 

ENM exposures.

 

2

Federal Register. See Fed. Reg. in References.
P a g e | 20

DRAFT: For review purposes only. Do not cite or quote. 

 Determine whether ENMs cause immune dysfunction.

 Explore the usefulness of biomarkers for determining the extent of worker exposure and the 

potential for adverse health effects.

 Conduct research on measurement methods for nanomaterials.

o Align laboratory and field exposure metrics and measurement techniques.

o Expand and refine workplace measurement techniques for assessing exposure (tiered 

approach).

o Develop a microscopy method for CNT and other ENMs.

o Identify the critical reference materials needed for measurement.

 Continue to evaluate additional ENMs for dustiness, explosibility, flammability, and electromagnetic hazard potential.

o Correlate dustiness, explosion, fire, and electromagnetic data to existing hazard indexes.

Develop and update guidance through collaborations

 Develop categorical and specific occupational exposure limits.

o Conduct research to recommend specific exposure limits for various ENMs (e.g., nanosilver, graphene, carbon black, nanoceramics, nano clays, nano silica, nano catalysts), and evaluate the adequacy of existing exposure limits.

 Identify categories of nanomaterials that can be distinguished by physicochemical parameters.

 Conduct risk assessments.

o Nanoparticle lung dosimetry modeling

o Categorization and comparative potency methods

 Link risk assessment, toxicology, exposure measurement, and control strategies.

 Develop guidance materials.

o Update guidance for medical surveillance (include sensitivity and specificity of 

medical tests).

o Evaluate and provide guidance on control technology.

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

o Use categorical approaches for ENMs to develop guidance on controlling exposures 

(hazard and control banding).

o Evaluate and provide guidance on PPE for use with ENMs.
P a g e | 21

DRAFT: For review purposes only. Do not cite or quote. 

 Partner with businesses to promote safe and responsible handling of ENMs.

 Determine whether there are potential applications of nanomaterials for safety and health (e.g.,

improved sensors or PPE).

Support epidemiologic and health surveillance studies for nanomaterial workers

 Conduct epidemiologic research on the health of nanomaterial workers.

 Partner with other U.S. agencies and groups that have begun epidemiologic and other 

surveillance studies.

 Determine medical surveillance for specific EMN exposures.

 Create an exposure database that harmonizes with global exposure databases.

Assess and promote national adherence with risk management guidance

 Conduct a national assessment to determine the extent of use of nanomaterial exposure controls and any barriers to their use.

 Provide intervention strategies for industry sectors where adherence to good risk management 

practices is low.

 Partner with other businesses, U.S. agencies, 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 research activities (see Section 4.4) for FY2013–

FY2016 that address the previously identified research needs and gaps (Section 4.1). Figure 7

provides a schema for how NIOSH will focus its research activities in accordance with the goals 

of the NTRC Strategic Plan:

(1) Increase toxicological understanding of new hazards and related health risks to nanomaterial 

workers.

(2) Expand the initial hazard findings of engineered nanomaterials.
P a g e | 22

DRAFT: For review purposes only. Do not cite or quote. 

(3) Support the creation of standards and 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 and exposure 

studies. 

(5) Assess and promote national adherence with risk management guidance. 

Figure 7. Focus of NIOSH nanomaterial research, 2013–2016.

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 controlling exposure below occupational limits. Research is proposed to develop and 

update good risk management practices, including categorical and specific exposure limits. Research 

data and information will be cataloged and shared via informatics (resources, devices, and methods 

required to optimize the acquisition, storage, retrieval, and use of information).
P a g e | 23

DRAFT: For review purposes only. Do not cite or quote. 

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 alignment of the 

NIOSH NTRC strategic goals and 10 NTRC critical research areas with the NNI EHS priority 

research needs (RN) (Appendix A). A check mark () means that a goal is addressed by current 

projects within the NTRC critical research area. Alphanumerical RN identifications indicate 

alignment of the NIOSH critical research goals with the NNI EHS priority research needs.

Table 1. Alignment of Critical Research Areas with the Five Strategic Goals of the NIOSH NTRC and the 

NNI EHS Priority Research Needs (RN)

NIOSH NTRC 

Strategic Goal/ 

Critical Research 

Area

Increase 

understanding of 

new hazards and 

related health risks 

to nanomaterial 

workers

Expand the initial 

hazard findings of 

engineered 

nanomaterials

Support the 

creation of 

guidance materials 

to inform 

nanomaterial 

workers and 

employers about

hazards, risks, and 

risk management 

approaches

Support 

epidemiologic 

studies for 

nanomaterial 

workers, including 

medical and 

exposure studies

Assess and promote 

national adherence 

with risk 

management 

guidance

Toxicity and internal 

dose



1

3-RN12

3-RN2

3-RN3

3-RN4

3-RN5



3-RN12

3-RN2

3-RN3

3-RN4

3-RN5



Measurement 

methods



1-RN1

1-RN2

1-RN3

2-RN1

3-RN2



1-RN1

1-RN2

1-RN3

2-RN1

3-RN2



Exposure assessment 

2-RN1

2-RN3

3-RN2

4-RN1

5-RN2



2-RN1

2-RN3

3-RN2

4-RN1

5-RN2



Epidemiology and 

surveillance

 

2-RN1

2-RN3

2-RN4

3-RN6

5-RN2



5-RN2

Risk assessment 

5-RN1

5-RN2



5-RN1

5-RN2



5-RN3

5-RN4
P a g e | 24

DRAFT: For review purposes only. Do not cite or quote. 

5-RN5 5-RN5

Engineering controls 

and PPE



2-RN1

5-RN1

5-RN2



2-RN1

5-RN1

5-RN2

 

5-RN2

Fire and explosion 

safety



1-RN5



1-RN5



Recommendations 

and guidance



5-RN3

5-RN4

5-RN5



5-RN2

Global 

collaborations3

    

4

Applications5 

1A check mark () indicates that a goal is addressed by projects within the NIOSH critical research area.

2Alphanumeric identifications indicate alignment of the NIOSH critical research area with the specific NNI priority 

research needs (see Appendix A).

3

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.

4NIOSH will work with other governments to determine global adherence.

5The 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 nanotechnology programs, and it has the 

potential to improve safety and health, such as through the development of advanced sensors or PPE.
P a g e | 25

DRAFT: For review purposes only. Do not cite or quote. 

4.5 Proposed NIOSH NTRC Research

The following proposed research for FY2013–FY2016 has been coalesced to focus on specific 

research needs to fill data gaps (see Section 4.2) and the EHS priority research needs of the NNI (see 

Section 4.3). As knowledge gaps are filled and as resources become available, these research priorities 

could change.

Strategic Goal 1 (PPNANSG1): Increase understanding of new hazards and 

related health risks to nanomaterial workers.

Intermediate Goal 1.1 (PPNANIG1.1): Conduct market forecasting and review available 

surveillance data to determine emerging commercial ENMs and next-generation uses of 

existing 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 

exposures.

Performance Measure 1.1.1: Complete an initial market research and forecasting report for 

internal use within FY2013. Update the report within 3 years. 

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. Determine dose-response and time-course 

relationships. Determine rates of clearance of these nanoparticles after pulmonary exposure and 

translocation to systemic organs; characterize systemic effects.

Performance Measure 1.2.1: Complete toxicologic studies on ENMs such as nanosilver, 

graphene, and nanocellulose, and present and publish the data at the Society of Toxicology 

and in the peer-reviewed literature by FY2016.

Intermediate Goal 1.3 (PPNANIG1.3): Determine whether nanomaterial toxicity can be 

categorized on the basis of physicochemical properties and mode of action.

Activity/Output Goal 1.3.1 (PPNANAOG1.3.1): Systematically investigate the physical 
P a g e | 26

DRAFT: For review purposes only. Do not cite or quote. 

and chemical 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 

toxic effects (e.g., oxidant stress, dissolution, fibrogenicity, 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 

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

nanomaterials and provide a basis for developing predictive algorithms for structure/function 

relationships and comparative toxicity analyses for risk assessment. Determine whether 

toxicologic data from new studies can be linked to existing toxicology data.

Performance Measure 1.3.1: By FY2016, determine 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): Conduct nanomaterial workplace exposure 

assessments at sites producing or using emerging ENMs.

Activity/Output Goal 1.4.1 (PPNANAOG1.4.1): Collaborate with nanomaterial business to

identify processes that may release nanomaterials 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. Publish summary findings in a peer-reviewed 

journal.

Performance Measure 1.4.1.2: Evaluate ENM use and risk management practices at 

second- and third-generation-user facilities. Publish summary findings in a peer-reviewed 

journal.

Strategic Goal 2 (PPNANSG2): Expand the initial hazard findings.

Intermediate Goal 2.1 (PPNANIG2.1): Conduct research to evaluate the adverse chronic 
P a g e | 27

DRAFT: For review purposes only. Do not cite or quote. 

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, publish a report on the carcinogenicity of 

carbonaceous nanomaterials, based on completed carcinogenicity-toxicology studies.

Intermediate Goal 2.2 (PPNANIG2.2): Determine whether human biomarkers of 

nanomaterial 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 responses to ENMs. 

Performance Measure 2.2.1: By FY2017, publish results of human biomarker studies.

Activity/Output Goal 2.2.2 (PPNANAOG2.1): Conduct research to determine whether

cardiovascular or immune responses are sensitive indicators of pulmonary exposure to 

ENMs. 

Performance Measure 2.2.2: By FY2016, publish findings on cardiovascular and immune 

responses to pulmonary exposure to ENMs.

Intermediate Goal 2.3 (PPNANIG 2.3): Determine the relevance of in vitro and in vivo 

screening tests to worker response to inhalation 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 

pharyngeal aspiration) vs. exposure extended over time (inhalation) of ENMs in rodent 

models.

Performance Measure 2.3.1: By FY2016, publish findings on the relationship of deposition 
P a g e | 28

DRAFT: For review purposes only. Do not cite or quote. 

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 transformation.

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

fibrogenicity, genotoxicity, and/or cell transformation over the next 2 to 4 years (FY2014–

FY2016).

Intermediate Goal 2.4 (PPNANIG2.4): Conduct research on measurement methods for 

nanomaterials.

Activity/Output Goal 2.4.1 (PPNANAOG2.4.1): Develop and improve methods and approaches (including direct reading and time-integrated sampling) for assessing workplace exposures to ENMs. 

Performance Measure 2.4.1: By FY2015, publish updated strategies for assessing workplace exposures.

Activity/Output Goal 2.4.2 (PPNANAOG2.4.2): Develop an analytical microscopy method for 

carbonaceous and other ENMs. Evaluate scanning electron microscopy, transmission electron 

microscopy, and dark-field microscopy.

Performance Measure 2.4.2: By FY2015, publish a microscopy method (or methods) for 

sample preparation, identification, and/or possible semiquantification that is applicable to 

some ENMs.

Activity/Output Goal 2.4.3 (PPNANAOG2.4.3): Continue interactions with the National 

Institute of Standards and Technology and international metrology institutes and perform coherent research to identify, develop, and qualify nanoscale reference materials (RMs) and 

benchmark materials for evaluating measurement tools, instruments, and methods for exposure assessment and toxicology. 
P a g e | 29

DRAFT: For review purposes only. Do not cite or quote. 

Performance Measure 2.4.3.1: By FY2014, complete a round-robin evaluation of a transmission electron microscopy (TEM) sample-preparation procedure using a National Institute 

of Standards and Technology (NIST) RM.

Performance Measure 2.4.3.2: By FY2014, translate this TEM sample-preparation procedure into a standard through ASTM Committee E56: Nanotechnology.

Performance Measure 2.4.3.3: Within 4 years (FY2016), utilize NIST RMs 8011, 8012, 

and 8013 to evaluate filter- and grid-based sample-collection techniques and TEM analysis 

for spherical ENMs. 

Performance Measure 2.4.3.4: By FY2016, develop four measurement protocols that utilize 

reference materials (as appropriate) for particle characterization for internal use to promote 

reproducibility of testing.

Performance Measure 2.4.3.5: By FY2016, develop four instrument sampling cards that include use of RMs (as appropriate) for internal use to promote measurement quality.

Activity/Output Goal 2.4.4 (PPNANAOG2.4.4): Understand relationships between laboratory instrumentation used to characterize aerosols for toxicology studies and fieldmeasurement instrumentation used to characterize workplace atmospheres.

Performance Measure 2.4.4: By FY2016, complete a series of studies to evaluate test atmospheres with laboratory and field-measurement instruments for a range of metrics, including particle number, size, and surface area.

Activity/Output Goal 2.4.5 (PPNANAOG2.4.5): Conduct further research on the dustiness 

testing of powders and to benchmark the Venturi (UNC) dustiness testing device against a 

more traditional dustiness test (e.g., a method prescribed in EN 15051).

Performance Measure 2.4.5: By FY2015, compare the Venturi dustiness testing device 

against at least one other method for a range of fine and nanoscale materials.
P a g e | 30

DRAFT: For review purposes only. Do not cite or quote. 

Activity/Output Goal 2.4.6 (PPNANAOG2.4.6): Conduct further research on determining 

the advantages and limitations of direct reading instruments in assessing nanoparticle workplace emissions and exposures.

Performance Measure 2.4.6: By FY2015, publish at least one further study on the performance of direct reading instruments for assessing nanoparticle emissions or exposures in the 

workplace.

Activity/Output Goal 2.4.7 (PPNANAOG2.4.7): Develop a method to correlate wipe sampling to potential dermal exposure to ENMs. 

Performance Measure 2.4.7: By FY2014, publish a method that correlates wipe sampling to 

potential dermal exposures. 

Activity/Output Goal 2.4.8 (PPNANAOG2.4.8): Conduct research to advance the use of nanomaterials in the development of sensors (e.g., detection of harmful chemicals) and other health 

and safety–related applications that can be used in the workplace to ensure effective control of exposure.

Performance Measure 2.4.8.1: By FY2016, develop an effective sensor employing nanomaterials for the real-time measurement of a workplace agent, and publish the results.

Performance Measure 2.4.8.2: By FY2016, compile and publish a compendium on applications of nanotechnology to improve workplace safety and health.

Intermediate Goal 2.5 (PPNANIG2.5): Conduct 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, flammability, explosibility, and electromagnetic 

hazards of ENMs. 
P a g e | 31

DRAFT: For review purposes only. Do not cite or quote. 

Performance Measure 2.5.1: By FY2016, publish findings that may influence the NFPA or 

Department of Transportation (DOT) placard information and the DOT Emergency Response 

Guidebook.

Intermediate Goal 2.6 (PPNANIG2.6): Develop and use informatics to process and 

communicate information.

Activity/Output Goal 2.6.1 (PPNANAOG2.6.1): Create a harmonized database to share 

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 

develop an open literature monograph on nanoinformatics principles and practice.

Performance Measure 2.6.2: Complete and publish the monograph by FY2015.

Strategic Goal 3 (PPNANSG3): 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.

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 highvolume ENMs.

Performance Measure 3.1.1: By FY2015, complete a quantitative risk assessment (QRA) 

on ultrafine and fine materials from existing studies. 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. 
P a g e | 32

DRAFT: For review purposes only. Do not cite or quote. 

Activity/Output Goal 3.1.2 (PPNANAOG3.1.2): Develop a risk-assessment framework for 

evaluating the hazard and predicting the risk of exposure to ENMs. 

Performance Measure 3.1.2: By 2017, develop a risk-assessment framework to rank hazard 

and estimate risk from exposure to selected ENMs in the workplace.

Activity/Output Goal 3.1.3 (PPNANAOG3.1.3): Use a hazard banding system to group 

ENMs.

Performance Measure 3.1.3: By FY2016, develop a hazard banding classification scheme 

for ENMs on the basis of toxicological, chemical, and physical properties. 

Intermediate Goal 3.2 (PPNANIG3.2): Conduct 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 

control techniques for ENMs and develop new approaches as needed. By FY2016, publish 

case studies, workplace survey reports, and updated engineering control solutions.

Performance Measure 3.2.1.1: Conduct field investigations of workplaces where ENMs are 

manufactured and used to evaluate existing engineering controls and make recommendations 

on improving exposure control. By FY2015, publish case studies and workplace survey reports and by FY 2016, publish updated engineering control solutions.

Performance Measure 3.2.1.2: Conduct lab evaluations of commercially available 

engineering controls for a variety of common ENM production, handling, and downstream

processes. By FY2016, publish in-depth reports and journal articles on the effectiveness of 

these control devices.

Activity/Output Goal 3.2.2 (PPNANAOG3.2.2): Evaluate the effectiveness of PPE (respirators, gloves, and protective clothing) for reducing worker exposures to ENMs.

Performance Measure 3.2.2: By FY2016, publish updated guidance on the effectiveness of 

PPE for reducing worker exposures to ENMs.
P a g e | 33

DRAFT: For review purposes only. Do not cite or quote. 

Intermediate Goal 3.3 (PPNANIG3.3): Incorporate PtD into nanomaterial health and safety 

programs.

Activity/Output Goal 3.3.1 (PPNANAOG3.3.1): Promote PtD principles for nanomaterials,

including safer nanomaterials that have the same functionality; process containment and control; and management system approaches to include occupational safety and health into the 

nanoparticle synthetic process, product development, and product manufacture.

Performance Measure 3.3.1: By FY2015, publish a document specific to PtD for 

nanomaterials.

Intermediate Goal 3.4 (PPNANIG3.4): Foster the collection, management, and 

dissemination of relevant information to protect nanomaterial workers.

Activity/Output Goal 3.4.1 (PPNANAOG3.4.1): Develop and disseminate effective information, education, and training materials to various target audiences such as nanotechnology 

workers and employers, occupational safety and health professionals, policy-makers, decision-makers, and/or the scientific community.

Performance Measures 3.4.1.1: By FY2015, update Approaches to Safe Nanotechnology: 

Managing the Safety and Health Concerns Associated with Engineered Nanomaterials.

Performance Measures 3.4.1.2: Update the Progress Report on the NIOSH Nanotechnology 

research and communication Efforts by FY2015. 

Performance Measure 3.4.1.3: Create new guidance documents on use of engineering controls, PPE, and PtD, as per Performance Measures 3.2.1.1, 3.2.1.2, 3.2.2, and 3.3.1.

Performance Measure 3.4.1.4: Support a conference on risk management of engineered nanomaterials, with a focus on engineering controls, by FY2016.

Intermediate Goal 3.5 (PPNANIG3.5): Enhance global workplace safety and health 
P a g e | 34

DRAFT: For review purposes only. Do not cite or quote. 

through international activities.

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

international partnerships with whom knowledge gaps, research needs and priorities, 

approaches, and databases could be shared.

Performance Measure 3.5.1.1: Strengthen coordination of research through governmentlevel organizations (e.g., OECD and UN). 

Performance Measure 3.5.1.2: Expand collaborations to developing nations and emerging 

powers.

Activity/Output Goal 3.5.2 (PPNANAOG3.5.2): Improve sharing critical data globally.

Performance Measure 3.5.2.1: Develop a global portal for information on ENMs relevant 

to occupational safety and health.

Performance Measure 3.5.2.2: If feasible, initiate the development of a global exposure 

registry database. 

Performance Measure 3.5.2.3: Participate in OECD Nanomaterial Safety Testing Program 

by sponsoring nanomaterial testing and by data exchange. 

Activity/Output Goal 3.5.3 (PPNANAOG3.5.3): Lead the development of global standards 

on occupational safety and health for nanotechnology.

Performance Measure 3.5.3.1: Over the next 3 years, lead the development of at least one 

standard in the International Organization for Standardization.

Performance Measure 3.5.3.2: Over the next 3 years, lead the development of at least one 

guidance document for the United Nations.

Performance Measure 3.5.3.3: Over the next 3 years, lead the development of at least one 

guidance document for the Organization for Economic Cooperation and Development.
P a g e | 35

DRAFT: For review purposes only. Do not cite or quote. 

Strategic Goal 4 (PPNANSG4): Support epidemiologic studies for 

nanomaterial workers, including medical and exposure studies.

Intermediate Goal 4.1 (PPNANIG4.1): Conduct epidemiologic research and evaluate 

feasibility of conducting surveillance of nanomaterial workers.

Activity/Output Goal 4.1.1 (PPNANAOG4.1.1): Complete the epidemiological health studies of U.S. workers exposed to CNTs and CNFs.

Performance Measure 4.1.1: By FY2016, complete data collection for industry-wide exposure 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 initiating worker exposure registries for workers exposed to existing nanomaterials (e.g., TiO2, 

CNT) or producing and using new nanomaterials. 

Performance Measure 4.1.2: By FY2016, develop a template and begin population of 

worker exposure registries.

Activity/Output Goal 4.1.3 (PPNANAOG4.2.3): Integrate nanotechnology safety and 

health guidance into existing hazard surveillance systems. Determine whether these systems 

are adequate by conducting evaluations.

Performance Measure 4.1.3: By FY2016, update NIOSH Current Intelligence Bulletin 60:

Interim Guidance for the Medical Screening and Hazard Surveillance of Workers Potentially 

Exposed to Engineered Nanoparticles [NIOSH 2009].

Strategic Goal 5 (PPNANSG5): Assess and promote national adherence with 

risk management guidance.
P a g e | 36

DRAFT: For review purposes only. Do not cite or quote. 

Intermediate Goal 5.1 (PPNANIG5.1): Determine 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 the NIOSH guidance 

recommendations are being adopted by businesses.

Performance Measure 5.1.1: Within the next 3 years, conduct formal and informal assessments of the controls used in ENM-producing or -handling facilities. BY FY2016, publish 

findings.

Activity/Output Goal 5.1.2 (PPNANAOG 5.1.2): Develop a plan for industrial sectors 

where adherence 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.

5 OUTPUTS

A summary of NIOSH NTRC research outputs and accomplishments are presented in the report 

Filling the Knowledge Gaps: A Report from the NIOSH Nanotechnology Research Center, from 

Inception in 2004 through 2011 [NIOSH 2012].

5.1. NIOSH Publications on Nanotechnology Since 2009

NIOSH NTRC scientists will continue to develop documentation that provides guidance and technical 

information for workers, employers, health professionals, regulatory agencies, and decision-makers in 

government, academia, industry, and labor. Examples of such documentation include the following:

 The recently ( November 2012) released Filling the Knowledge Gaps for Safe 

Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology 

Research Center, 2004–2011, DHHS (NIOSH) Publication No. 2013-101. It is available at 

http://www.cdc.gov/niosh/docs/2013-101/

 Current Intelligence Bulletin (CIB) 63, Occupational Exposure to Titanium Dioxide, DHHS 
P a g e | 37

DRAFT: For review purposes only. Do not cite or quote. 

(NIOSH) Publication No. 2011-160. This document includes a recommended exposure 

limit for both fine and ultrafine (nano) titanium dioxide (TiO2). It is available at 

http://www.cdc.gov/niosh/docs/2011-160/.

 A draft CIB, Occupational Exposure to Carbon Nanotubes and Carbon Nanofibers, was 

available on the NIOSH topic page for public comment in fall 2010. This document 

includes a recommended exposure limit for carbon nanotubes and nanofibers. It is 

available at http://www.cdc.gov/niosh/docket/review/docket161A/.

 NIOSH sponsored a supplement to the Journal of Occupational and Environmental 

Medicine, entitled Selected Papers from the Nanomaterials and Worker Health, Medical 

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. A progress 

report on the status of nanotechnology research conducted by the NIOSH NTRC 2007–2008.

http://www.cdc.gov/niosh/docs/2010-104/

 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/

 NIOSH [2009]. Interim guidance for medical screening and hazard surveillance for 

workers potentially exposed to engineered nanoparticles. DHHS (NIOSH) Publication

No. 2009–116. http://www.cdc.gov/niosh/docs/2009-116/

5.2. NIOSH Peer-Reviewed Publications

NIOSH NTRC scientists will continue to publish results of research as the data become available. 

More than 400 peer-reviewed articles were published between 2004 and 2011 addressing scientific 

and technical issues in the field of nanotechnology. NIOSH will continue to evaluate the utility of its 

publications and their impact on the scientific, regulatory, and occupational health community.
P a g e | 38

DRAFT: For review purposes only. Do not cite or quote. 

5.3 Sponsored Conferences

The NIOSH NTRC will continue to partner with others in sponsoring and conducting conferences on 

nanotechnology. To date, NIOSH has co-sponsored 15 international nanomaterial health and safety 

meetings. NTRC staff also participated on several scientific and technical panels convened by 

government agencies, nongovernmental agencies, and professional associations.

5.4 Presentations 

NTRC staff will continue to deliver presentations nationally and internationally concerning 

occupational safety and health issues associated with nanotechnology, including presentations at 

scientific conferences, and trade and professional associations. To date, NTRC staff members have 

given more than 650 presentations on nanomaterial health and safety topics. 

6 RESEARCH TO PRACTICE (r2p)

Research to practice (r2p) involves the translation of research into products, practices, and usable 

information. The NIOSH NTRC nanotechnology strategic plan reflects the r2p vision to work with 

partners and stakeholders to translate research findings into NIOSH products (e.g., guidance 

documents, instrumentation, nanoparticle filtration methods, and exposure controls) that will be used 

to reduce or prevent worker injury 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 collaborating with a number of industries to develop appropriate 

engineering controls and effective administrative practices for the safe handling of nanomaterials.

Specifically, the NTRC will continue to work with industry and labor in evaluating workplace 

exposures to ENMs and provide recommendations that will minimize worker exposures. The NIOSH

NTRC will continue to make recommendations and provide information based on its research and 

findings reported in the published scientific literature. The recommendations will pertain to all areas of 

risk management described in Section 4.1.
P a g e | 39

DRAFT: For review purposes only. Do not cite or quote. 

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, Consumer Product Safety Commission (CPSC), and 

National Institute of Environmental Health Sciences (NIEHS).

7.2. Standards Development Organizations

NIOSH actively participates in the development of national and international standards for promoting 

the health and safety of workers in the nanotechnology industries. The NIOSH NTRC participates in 

the American National Standards Institute (ANSI) Nanotechnology Standards Steering Panel, which 

coordinates the identification and development of critical standards in all areas of nanotechnology.

NIOSH NTRC scientists also participate in the American Society for Testing and Materials (ASTM)

International E56 Committee on Nanotechnology, which is developing an integrated family of 

standards. Committee E56.03 is addressing environmental and occupational safety and health. 

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

Advisory Group to the International Organization for Standardization (ISO) Technical Committee 229 

on Nanotechnologies (ISO TC 229).

7.3. Industry, Labor, and Academia 

NIOSH is coordinating input from industry, labor, academics, and a wide range of government 

agencies in creating guidance for occupational health surveillance. Additionally, the NIOSH 

NTRC plans to coordinate input from those same groups of partners and stakeholders with the 

goal of developing standardized data systems for epidemiological research in workplaces 

producing and using nanomaterials. Through collaborations with industry, government, and 
P a g e | 40

DRAFT: For review purposes only. Do not cite or quote. 

academia, NIOSH 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 

characterize occupational exposure to ENMs and implement effective risk-management practices 

to minimize worker exposure to ENMs. 

7.4. Professional Organizations

NIOSH is collaborating with various professional organizations, including the American Industrial 

Hygiene Association (AIHA) and National Safety Council (NSC), to identify mutual efforts for 

developing new worker training programs.

7.5. Research Collaborations

NIOSH has established several national and international collaborations to advance research into the 

safe use of nanotechnology. The NIOSH NTRC participates in the National Nanotechnology Initiative 

(NNI) and has contributed to the nanotechnology environmental, health, and safety (EH&S) research 

strategy for the nation through the working group of Nanotechnology Environmental and Health 

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

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

7.6 International Activities

NIOSH will continue to engage with a number of international entities at all levels—as principle 

investigator as well as in national, regional, 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 Laboratory, the Netherlands 

Organization for Applied Scientific Research (TNO), the French Agency for Food, Environmental 

and Occupational Health and Safety (ANSES), the Finnish Institute of Occupational Health, and the 

Australian Safety and Compensation Council (Safe Work Australia).
P a g e | 41

DRAFT: For review purposes only. Do not cite or quote. 

NIOSH is collaborating with the Organization for Economic Cooperation and Development (OECD) 

to build cooperation, coordination, and communication between the United States and 30 OECD 

member countries, including the European Union (EU), and more than 180 nonmember economies.

NIOSH is also working with the UN World Health Organization (WHO), the UN International 

Labour Organization (ILO), the International Organization for Standardization (ISO), the International 

Commission on Occupational Health (ICOH), and the International Council on Nanotechnology 

(ICON) on global projects of information dissemination and communication.

8. OUTCOMES

 Nanotechnology is a rapidly developing area of science and technology that promises great benefits.

To realize these benefits, it is important to protect workers potentially exposed to ENMs in 

nanomaterial research, production, and use [Schulte and Salmanaca-Buentello 2007, Nasterlack et al. 

2008; Howard and Murashov 2009]. The NIOSH NTRC strategic plan is designed to identify and 

create the information needed for risk management programs that will control and prevent negative 

impacts on worker health. Outcomes of the NIOSH NTRC research will be translated into products 

that can be used by the nanotechnology community to develop and implement appropriate risk 

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

research results and risk management guidance developed by NIOSH influences others to take action 

to prevent exposure to hazards related to ENMs.

NIOSH will assess the extent to which its research efforts have addressed each element of the risk 

management process (illustrated in Figure 4) and determine how the outcomes of research 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 time period. A summary of proposed research for 

FY2013–2014 and FY2015–2016 is shown in Appendix B.
P a g e | 42

DRAFT: For review purposes only. Do not cite or quote. 

REFERENCES

Howard J, Murashov V [2009]. National nanotechnology partnership to protect workers. J Nanopart Res 11:1673–1683.

ISO [2008]. Nanotechnologies: terminology and definitions for nano-objects—nanoparticle, 

nanofibre and nanoplate. ISO/TS 27687. Geneva, Switzerland: International Organization for 

Standardization.

Murashov V, Schulte PA, Howard J [2012]. Progression of occupational risk management with 

advances in nanomaterials. J Occup Environ Health 9:D12–D22.

Nasterlack M, Zober A, Oberlinner C [2008]. Considerations in occupational medical 

surveillance of employees handling nanoparticles. Int Arch Occup Environ Health 81:721–726.

NIOSH [2007]. Progress toward safe nanotechnology in the workplace. Cincinnati, OH: U.S. 

Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2007-123.

NIOSH [2009a]. Approaches to safe nanotechnology: managing the health and safety concerns 

associated with engineered nanomaterials. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational 

Safety and Health, DHHS (NIOSH) Publication No. 2009-125. 

NIOSH [2009b]. Interim guidance for medical screening and hazard surveillance for workers 

potentially exposed to engineered nanoparticles. Cincinnati, OH: U.S. Department of Health and 

Human Services, Centers for Disease Control and Prevention, National Institute for Occupational 

Safety and Health, DHHS (NIOSH) Publication No. 2009-116.

NIOSH [2010]. Progress toward safe nanotechnology in the workplace: a report from the NIOSH 

Nanotechnology Research Center. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and 

Health, DHHS (NIOSH) Publication No. 2010-104.

NIOSH [2010]. Strategic plan for NIOSH nanotechnology research and guidance. Cincinnati, 

OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 

2010-105.

NIOSH [2011]. Current intelligence bulletin 63: occupational exposure to titanium dioxide. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and 

Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 

No. 2011-160.
P a g e | 43

DRAFT: For review purposes only. Do not cite or quote. 

NIOSH [2012]. Filling the knowledge gaps: a report from the NIOSH Nanotechnology Research 

Center, from inception in 2004 through 2011. Cincinnati, OH: U.S. Department of Health and 

Human Services, Centers for Disease Control and Prevention, National Institute for Occupational 

Safety and Health, DHHS (NIOSH) Publication No. 2013-101.

NNI [2001]. National Nanotechnology Initiative: interagency agreement. Washington, DC: United States Executive Office of the President, Office of Science and Technology Policy

[http://www.nano.gov/html/about/home_about.html].

NNI [2011]. National Nanotechnology Initiative: environmental, health, and safety research

strategy. Washington, DC: United States Executive Office of the President, Office of Science 

and Technology Policy, Nanotechnology Environmental and Health Implications (NEHI) 

Working Group.

NSF [2011]. Nanotechnology research directions for societal needs in 2020: retrospective and 

outlook summary. National Science Foundation. In: Roco M, Mirkin C, Hersan M, eds. Science 

Policy Reports. New York: Springer (DOI: 10.1007/978-94-007-1168-6_5). 

Schulte P, Geraci C, Zumwalde R, Hoover M, Kuempel E [2008]. Occupational risk management of engineered nanoparticles. J Occup Environ Hyg 5:239–249.

Schulte PA, Salamanca-Buentello F [2007]. Ethical and scientific issues of nanotechnology in 

the workplace. Environ Health Perspect 115:5–12.

Schulte PA, Schubauer-Berigan MK, Mayweather C, Geraci CL, Zumwalde R, McKernan JL

[2009]. Issues in the development of epidemiologic studies of workers exposed to engineered 

nanoparticles. J Occup Environ Med 51(3):323–335.
P a g e | 44

DRAFT: For review purposes only. Do not cite or quote. 

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 Technology Policy, Nanotechnology Environmental and Health 

Implications (NEHI) Working Group, Table D-1.]
P a g e | 45

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 46

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 47

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 48

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 49

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 50

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 51

DRAFT: For review purposes only. Do not cite or quote. 
P a g e | 52

DRAFT: For review purposes only. Do not cite or quote. 

APPENDIX B: Timeline for NIOSH Nanotechnology Research

Critical Research 

Area

Projects

Summary of Proposed Research Projects, FY2013–FY2014

Toxicity and Internal 

Dose

Evaluate long-term fibrogenic and carcinogenic potential of carbon 

nanotubes and carbon nanofibers.

Determine immune and cardiovascular responses to pulmonary exposure to 

CNT, TiO2, and/or nanosilver.

Evaluate the pulmonary effects of nanosilver.

Measurement

Methods

Develop updated methods and approaches to assess occupational exposures 

to nanomaterials.

Utilize reference materials and technically sound protocols to improve 

measurement quality.

Develop techniques to characterize nanoparticles, using advanced 

microscopy methods.

Study the performance of direct reading instruments for assessing emissions 

and exposure to nanoparticles in the workplace.

Exposure 

Assessment

 Complete evaluation of workplace exposures to emerging, second-, 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 

carbonaceous nanomaterial workers.

 Collect data on specific biomarkers as markers of exposure or early health 

endpoints in workers exposed to carbon nanotubes or carbon nanofibers.

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 

biological mode of action, and perform case study evaluations for 

nanomaterials 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 
P a g e | 53

DRAFT: For review purposes only. Do not cite or quote. 

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 magnetic 

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, use of a wind tunnel in testing, 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 current DOT and NFPA guidance for adequacy with ENMs.

 Update pertinent safety issues and recommendations. 

 Evaluate a variety of ENMs for electromagnetic hazard potential.

 Correlate dustiness of ENMs with various physical and chemical safety 

hazards.

Recommendations 

and Guidance

Continue conducting r2p activities (ongoing), such as the development of 

brochures, fact sheets, updating the topic page, etc. 

Develop hazard bands and RELs for most commercially available ENMs.

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.
P a g e | 54

DRAFT: For review purposes only. Do not cite or quote. 

Appendix B table, continued

Summary of Proposed Research Projects for FY2015–FY2016

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 or nanocellulose.

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 protocols.

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 epidemiologic 

study among carbon nanotube– and carbon nanofiber–exposed workers.

Risk Assessment  Extend evaluations of the hazard and risk of workplace exposure to new nanomaterials.

 Utilize the latest data from toxicity studies, workplace exposure measurements, and/or biomonitoring data to identify potential hazards in the respiratory tract and/or other organs.

 Contribute to the refinement and validation of dosimetry models for nanomaterials. 

 Contribute to the evaluation and development or update of recommended 

exposure limits and other risk management guidance.

Engineering Controls 

and PPE

Continue to assess engineering controls in the field and update 

recommendations 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 

 Evaluate nano metals and other ENMs for fire and explosion potential.

 Evaluate current DOT and NFPA guidance for adequacy with ENMs.
P a g e | 55

DRAFT: For review purposes only. Do not cite or quote. 

 Update pertinent safety issues and recommendations. 

 Evaluate a variety of ENMs for electromagnetic hazard potential.

 Correlate dustiness of ENMs with various physical and chemical safety 

hazards.

Recommendations 

and Guidance

Update Approaches to Safe Nanotechnology

Applications Evaluate ENM-enabled PPE.

Global Activities  Lead or co-lead committees with globally recognized organizations ICON, 

ISO, OECD, and UN (WHO, ILO).