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 Do not cite or quote.DRAFT: For review purposes only. Do not cite or quote.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 Nanote chnology Research Center ,

FY2013

– FY 20 16
DRAFT Dec ember 2 012

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 pro ducts. 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 saf ety 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. 20 1 3

– XXX Dec em ber 20 12

Safer • Healthier • People TMDRAFT: 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 Do not cite or quote.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 Rese arch 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 cl othing, 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 nanom aterials. The research conducted over t he past 8 years has proven that NIOSH is a global leader in promoting the responsible development of nanotechnology. NIOSH has built business partners hips , established itself as a key player in nanotoxicology, publis hed precautionary guidance ( Approaches to Safe Nanotechnology : Managing the Safety and Health Concerns Associated with Engine ered N anomaterials ), and issued rec ommended exposure limits for nanoscale titanium dioxid e 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 M odel

................................ ................................ ................................ ..... 7
2

. Inputs

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

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

................................ ................................ ............ 10
2. 3 C ustomers’ and Stakeholders’ Input

................................ ................................ ........... 1 1
2

. 4 NIOSH R esearch C apabilities

................................ ................................ ..................... 1 2
2

. 5 NIOSH Partnerships

................................ ................................ ................................ .... 1 3
3

. Activities

................................ ................................ ................................ ......................... 1 4
3

. 1 NIOSH Nanotechnology Research Center (NTRC)

................................ .................. 1 4
3.2 N TRC Steering Committ ee
................................ ................................ ......................... 1 5
3

. 3 Current NIOSH Intramural Nanotechnology Research Activities

.............................. 1 5
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 Go als , and Activity/Output Goals

............................... 25DRAFT: For review purposes only. Do not cite or quote.

5

. Outputs

................................ ................................ ................................ ............................ 36
5

. 1 NIOSH P ublications on Nanotechnology Since 2009

................................ ................ 36
5

. 2 NIOSH P eer
- reviewed P ublications

................................ ................................ ........... 37
5

. 3 Sponsored C onferences

................................ ................................ ............................... 37
5

. 4 Presentations

................................ ................................ ................................ ............... 38

6

. Research to Practice

................................ ................................ ................................ ........ 38
6

. 1 Capacity B uilding through T echnical A ssistance

................................ ....................... 38

7

. Intermediate C ustomers and I ntermediate O utcomes

................................ ..................... 39
7

. 1 Federal Government A gencies

................................ ................................ .................... 39
7

. 2 Standards D evelop ment O rganizations

................................ ................................ ....... 39
7

. 3 Industry , Labor , and Academia

................................ ................................ ................... 39
7

. 4 Professional O rganizations

................................ ................................ ......................... 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

.................... 4 4 Appendix B

. Timeline for NIOSH Nanotechnology Researc h

................................ ............... 52P 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 20 20 , 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 U nited States. Nanomaterials may present new challenges to understanding, predicting, and managing potential health risks to workers.
M any 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
Na notechnology and the commercial ization 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 ben efits may not be realized if cautions about the adverse effects are not heeded and concerns are not honored. T imely targeted research is needed to define risks and provide g uidance 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 ne w 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, 201 2 ], 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 identif ied 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 toP 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)
N IOSH 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 scientif ic 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 the ir 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).

I n the coming 3 years, NIOSH will marshal its re sources and partner with others efficiently and effectively to advan c e 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 na note chnology research and guidance . The most recent version was p ublished in November 2009 and inclu ded research plans through FY 12 (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 FY 20 13

– FY 20 16

. The strategic p lan also highlights how NIOSH’s critical resear ch and guidance efforts align with and support the National Nanotechnology Initiative’s comprehensive Environmental , Health , and Safe ty Research Strategy needs . For the period FY 20 13

– FY 20 16 , NIOSH will continue to fill information and knowledge gaps that address the five NIOSH NTRC strateg ic 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, employer s , 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 adhe rence 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) epidemiologyP 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 a nd guidance, (9) global collab orations, and (10) applications

.



## 1 INTRODUCTION 1.1 Background Nanotechnology is a system of innovative methods to control and manipulat e matter at near

- atomic scale to produce new materials, structures, and devices. Nanoparticles are a specific class or subset of these new materials, hav ing three dimension s that are less than 100 nanometers

. Nano

- objects, a subset of nanoparticles , have at least one dimension less than 100 nan ometers [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 tha t may benefit society, such as integrated sensors, semiconductors, medical ima ging, drug delivery systems, structural materials, sunscreens, cosmetics, and coatings. Nanotechnology is one of the most rapidly growing industries across the world. By 20 20 , the global market for nanotechnology

- related
p roducts is predicted to reach $3 t rillion 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 a lso 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 present s new occupational safety and health risks. At the same time, there is a need to address how the benefits of nanotechnology c an 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, t he President’s Council of Advisors on Science and Technology collaborated with the interagency National Science and Technology Council to create theP 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 lead s 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 1 970 (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 a cts was to assure, insofar as possible, safe and healthful working conditions for every working m an and woman , to preserve our human resources. In these a cts, 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 s tandards 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 settin g 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 o ut 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 recommendation s for occupational safety and health. During this period, NIOSH has developed considerable expertise inP 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 participat es 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 iss ues, 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. T hrough t he NTRC , NIOSH has identified 10 critical research areas for nanotechnology research and communication. These 10 critical research areas , updated for FY 20 13

– 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) reco mmendations and guidance, ( 9) global collaborations , and ( 1 0) applications

. By conducting a complete plan of research in these critical areas in a coordinated,
concurrent manner , NIOSH is comprehensively address ing the information and knowledge gaps necessary to protect workers and responsibly move nanotechnology forward so that its far

reaching benefits may be realized.

The NIOSH NTRC is working strategically to fill nanomaterial occupational safety and health kn owledge gaps through active intramural and extramural research program s and collaborations

. Extramural research is carried out t hrough the NIOSH Office of Extramural Programs (OEP) , in which nanotechnology research (R01, R21, R43/44) is funded to increase the knowledge ofP 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 engi neered 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 Heal th, Safety, and the Environment and continue s to work with the World Health Organization collaborati ng centers on global projects of information dissemination and communication . Through these collaborations the NIOSH NTRC assist s in developing risk communi cations on the safe handling of nanomaterials

.

1. 3 NIOSH Logic M odel
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 p roceeding 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 r esearch ( a ctivities ) produce s “ 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 a

nd 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. S ince 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 e ffectiveness 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.

Activities Outputs Outcomes Inputs Customers Operations

Intermediate Goals Mission

Strategic Goals Strategy and design Annual Goals Management Objectives

External factorsP 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 nanomaterial s and development of priorities that will be benefici al 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 wo rkplaces 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 seeks input through formal committees such as the NIOSH Bo ard 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 te lephone 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 Agen da (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 comm unity.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 Imp lications Working Group (NEHI) and contributed to the development of the 2011 NEHI Environmental, Health , and Safety (EH S) Research Strategy

. The 2011 NEHI EH S research strategy identified fiv e core nano technology EHS research categories : (1 ) nanomaterial measurement infrastructure , (2 ) h uman exposure assessment , (3 ) human health , (4 ) environment , and (5 ) r isk assessment and m anagement m ethods (Appendix A ) [NNI 2011 ]

. NIOSH provide d significant input for the strategy and was the lead agency for developing recommendations on human exposure assessment. T he NNI EHS research strategy focuses on the use of science

- based risk analysis and risk management to protect public health and the

en vironment while also fostering the technological advancements that benefit society. T he 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 NI OSH NTRC also foster s stakeholder input with trade associations, professional associ ations, la bor, nongovernmental organizations , and a number of private nanomaterial companies

. These collaborations have provided expertise and resources critical for reviewing research activ ities and for developing and disseminating health and safety information on engineered nanopa rticles. S ome of the ongoing NTRC stakeholders are the American Industrial Hygiene Association (AIHA) , American Society of Safety Engineers (ASSE), International Safety Equipment Assoc iation, 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 wo rld

- class research capability of NIOSH is an integral part o f management ’s inputs for the nanotechnology program. Within its D ivisions , 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 th is 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 tox icity and pathogenesis. L aboratories conducting nanomaterial research are located in Cincinnati, Ohio; Pittsburgh, Pennsylvania; and M organtown, 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 capa city 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 capabilit ies by leveraging activities and expertise found in other research institutions, industr ies , federal agencies, and n ongovernmental o rganizations. 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 partnershi ps as a means of achieving the goals of this strategic research plan and as effective vehicle s 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 nano materials , ( 3) develop sampling and analytical methods , ( 4) evaluat e exposure controls that are or could be used in nanomaterial processes , ( 5) evaluat e the need for and determine the effectiveness of PPE , including respiratory protection , and ( 6) develop communication and information materials that will assist industry i n communicating with workers and the public. Several of the industrial partnerships h ave 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 c ollaboration with other national and international research institutes, academi a, and government agencies provide s the NTRC the opportunity to combine its expertise in workplace health and safety with the capabilit ies of other organization s to investigat e specific areas of concern. W orking 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 practic es.

The N TRC has broadened its activities with collaborators and stakeholders by participatin g in a number of national and international committees and working groups. This participation provides NTRC scientists the opportunity to provide and receive inp ut on the key research that is needed to address priority areas.



## 3 ACTIVITIES

3.1 NIOSH N anotechnology Research Center (N TRC )

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 inju ry 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 N TRC Steering Committee
The NTRC steering c ommittee is chaired by the NTRC C oordinator. 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 coord inators). The s teering committee is responsible for guiding NIOSH scient ific 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. R egular updates and progress reporting on internal research ac tivities is managed through biweekly teleconferences among members of the NTRC steering committee. In addition, t o 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 fro m ongoing research studies with engineered nanoparticles are used to better understand workplace nanoparticle
exposure s , the hazards posed by nanomaterials, and the potential risk of adverse he alth effects from occupational exposures. Studies are also provid ing 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 provid ing 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 N

anotechnology Research Center, 2004

– 2011 [NIOSH 201 2 ].

3.3.1 Evaluation of the nanotechnology research program NIOSH evaluates its research progress in nanotec hnology 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 NIOSHP 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 physic al and chemical p roperties, ( 2) recommendin g 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 proje ct 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 relevanc e, 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 i n the document Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004

– 2011 [ NIOSH 201 2 ]. 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, t he NIOSH OEP continues to support nanotechnology research that focuses on occupational safety and health issues

. I n addition, t he NIOSH OEP routinely confer s with the NIOSH N TRC regarding research needs

.

1 This 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, t here is need to address each element in the ris k management continuum.
The process for managing potential workplace exposures to engineered nanoparticles during the ir synthesis and incorporation into new materials and devices consists of the following step s to ascertain the appropriate risk management strategy : 1) identif ying 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 harmfu l to workers. A goal of t

he risk characterization is to determine whether exposure to a given technology or type of material (in this case, nano material s) is likely to result in adverse health effects. E xposure 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 add ress 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 k

nowledge gaps in protecting nanomaterial workers

.

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

. Inform ation 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 Expose d 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) comm ents rec eived in the Docket on the draft strategic goals [ 76 Fed. Reg. 2 123612] ; ( 5) the 2011 NEHI Enviro nmental, Health , and Safety (EH S) Research Strategy ; and ( 6) various scienti fic meetings and collaborations including tripartite attendance (labor, industry, and government)

. Based on this information , t he following data needs and research gaps have been identified : Identify new hazards and related health risk s to workers

 Identify emerging commercial engineered nanomaterials (ENMs) through market forecasting and research, technology surveil lance, and partner and stakeholder input.

 Determine how workers might be exposed to nanoparticles during manufacturin g 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 effect s.

 Demonstrate effective risk mitigation practices

Increase understanding of the initial hazard findings

 Determine carcinogenicity of carbon nanotubes ( CNT s)

.

 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 dysfunct ion

.

 Explore the use fulness 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 m easurement techniques for assess ing exposure (tie red approach)

.
o Develop a microscopy method for CNT and other ENMs

.
o Identify the critical reference materials needed for measurement

.

 Continue to e valuate additional ENMs for dustiness , explosibility , flammability , and electr omagnetic hazard potential

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

D evelop and update guidance through collaborations

 Develop categorical and specific occupational exposure limits

.
o Conduct research to r ecommend specific exposure limits for various ENMs (e.g. , n anosilver, graphene, carbon black, nanoceramics, nano clays, nano silica, nano cat alysts) , and evaluate the adequacy of existing exposure limits

.

 Identify categories of nanomaterials that can be distinguished by physico chemi cal 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 d evelop guidance on controlling exposures (hazard and control banding)

.
o Evaluate and provide guidance o n 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. a gencies and groups that have begun epidemiologic and other surveillance studies

.

 Determine medical surveillance for specific EMN exposures

.

 Crea te an exposure database that harmonize s 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 co ntrols and any barriers to the ir use
.

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

.

 Partner with other businesses, U

. S

. a gencies, and the international community to promote safe , responsib le development of nanomaterials

.

4. 3 Coalescing Priorities for NIOSH N TRC Research and Guidance for FY2013

– FY2016

T he NIOSH NTRC has proposed specific research activities (see Section 4.4) for FY2013

– FY2016 that address the previously identified resea rch needs and gaps ( Section 4.1 )

. Figure 7 provides a schema for how NIOSH will focus its research activities in accordance with the go als of the N TRC 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 n ano material workers , including medical and exposure studi es. ( 5 ) Assess and promote national adherence with risk management guidance.

Figure 7
. Focus of NIOSH nanomaterial research , 201 3

– 20 16
.

The overall focus of the strategic plan will be to continue to generate data, information, and knowledge to protect the nanotech n ology workforce , by using effective risk management techniques and particularly controlling exposure below occupational limits. Research is proposed to develop and update good risk manage ment practices , including categorical and specif ic 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 cr itical 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 Criti cal 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 Sup port

epidemiologic studies for
nan omate rial workers , including medical and exposure studies Assess and promote

national adherence with risk management guidance

Toxicity and internal dose  1 3

- RN1 2 3

- RN2 3

- RN3 3

- RN4 3

- RN5 

3

- RN1 2 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 a ssessment  5

- RN1 5

- RN2 

5

- RN1 5

- RN2 

5

- RN3 5

- RN4P 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 collaborations 3      4

Applications 5 

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

.

2 Alphanumeric identifications indicate alignment of the NIOSH critical research area with the specific NNI priorit y research needs (see Appendix A ).

3 International engagement is a priority of the NNI and a critical component of the 2011 NNI EHS Research S trategy

. However , it is not identified as a research need in the NNI Strategy

.

4 NIOSH will work with other govern ments to determine global adher ence
.

5 The N NI 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 P roposed NIOSH NTRC Research
The following proposed research for FY2013

– FY2016 has been coalesced to foc us on specific research needs to fill dat a gaps (see Section 4.2) and the EH S 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 toxicol ogical 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. Activit y/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

- res ponse 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 n anosilver, 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 na n omaterial toxicity can be categorized on the basis of physicochemical properties and mode of action.
Activit y/Output Goal 1.3.1 (PPNANAOG1. 3 .1) : Systematically investigate the physicalP 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).
Activit y/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.
Activit y/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 anal yses 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) o n 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 i dentify 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 em erging 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 chronicP 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, p ublis h a report on the carcinogenicity of carbonaceous nanomaterials , based on completed carcinogen i city

- 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, p ublish 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, p ublish findings on cardiovascular and immune
respons es 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 (inhalatio n) of ENMs in rode nt models

. Performanc e Measure 2.3.1 : By FY2016, p ublish findings on the relationship of depositionP a g e | 28

DRAFT: For review purposes only. Do not cite or quote. patterns and biological responses to pulmonary bolus exposure vs. exposur e 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, genotoxicit y, 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 a pproaches (including direct reading and time

- integrated sampling) for assessing workplace e xposures to ENMs.

Performance Measure 2. 4 .1 : By FY2015, publish updated strateg ies for assessing wor kplace exposures

. Activity/Output Goal 2. 4 .2 (PPNANAOG2. 4 .2 ) : Deve lop an analytical microscopy method for carb onaceous and other ENMs

. Evaluate scanning electron microscopy , transmission electron microscopy, and dark

- field microscopy

. Performance Measure 2. 4 .2 : By FY2015, p ublish a micr oscopy 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 c oherent research to identify, develop, and qualify nanoscale reference materials ( RMs ) and benchmark materials for evaluating measurement tools, instruments, and methods for exp osure 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 tran smission electron microscopy (TEM) sam ple

- 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 pro c edure 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, d evelop four measurement protocols that utilize reference materials (as appropriate) for particle characterization for internal use to promote reproduci bility of testing

.
Performance Measure 2.4.3.5 : By FY2016, d evelop four instrument sampling cards that i nclude use of RMs (as appropriate) for internal use to promo te measurement quality

. Activity/Output Goal 2. 4.4 (PP NANAOG2.4.4 ) : Understa nd relationships between labor atory instrumentation used to characterize aerosols for toxicology studies a nd field

measure ment instrumentation used to characterize workplace atmospheres
.
Performance Measure 2. 4.4 : By FY2016 , complete a series of studies to evaluate test a tmospheres with laboratory and field

- measurement instruments for a range of metrics , inclu ding 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 work

place emissions and exposures.

Performance Measure 2. 4.6 : B y FY2015, publish at least one further study on the perfo rmance of direct reading instruments for assessing nanoparticle emissions or exposures in the workplace.
Activity/Output Goal 2.4. 7 (PPN ANAOG2.4.7 ) : Develop a method to correlate wipe sa mpling 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 n anomaterials 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 e xposure.

Performance Measure 2. 4. 8 .1 : By FY2016, develop an effective sensor employing nan omaterials for the real

- time measurement of a workplace agent , and publish the result s.

Performance Measure 2.4
. 8 .2 : By FY2016 , compile and publish a compendium on applic ations of nanotechnology to improve workplace safety and health.

Intermediate Goal 2.5 (PPNAN IG2.5 ) : 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 contribu te to dustiness, combustibility , flammabil ity , 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 G uidebook.

Intermediate Goal 2. 6 (PPNAN IG2.6 ) : Develop and u se 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 r esults 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 n anoinformatics p rinciples a nd p ractice.

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 Goa l 3.1.1 (PPNANAOG3.1 .1 ) : Conduct a risk assessme nt for high

volume 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 nanomater ials. 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 r isk of exposure to ENMs

.
Performance Measure 3.1.2 : By 2017, develop a risk

- assessment framework to rank hazard and estimate risk from ex posure to selected ENMs in the workplace.
Activity/Output Goal 3.1.3 (PPNANAOG3.1 .3) : Use a hazard banding system to group ENMs.

Perfor mance 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

.
Activit y/Output Goal 3.2.1 (PPNANAOG3.2.1 ) : Evaluate the effectiveness of engineering

con trol techniques for ENMs and develop new approaches as needed. By FY2016, p ublish case studies, workplace survey reports , and updated engineering co ntrol solutions.

Performance Measure 3.2.1 .1 : Conduct field investigations o f 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 r eports and by FY 2016, publish upda ted engineering control solutions

.
Perfo rmance Measure 3.2
. 1. 2 : Conduct lab evaluations of commercially available engineering controls for a variety of common ENM production, handling, and downstr eam processes. By FY2016 , publish in

- depth reports and journal articles on the effectiveness of these control devices.
Activity/Output Goal 3.2 .2 (PP NANAOG3.2 .2) : Evaluate the effectiveness of PPE ( resp irators, gloves , and protective clothing) for reducing w orker exposures to ENMs

.
Perfo rmance Measure 3.2 .2 : By FY2016, publish updated guidance on the effectiveness of PPE for reducing work er 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 nano materials that have the same functionality; process containment and co ntrol; and management system approaches to include occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture.
Perfo rmance 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 info rmation, education, and training materials to various target audiences such as nanotechnology

wor kers and employers, occupational safety and health professionals, policy

- makers, dec ision

- makers, and/or the scientific community.

Performance Measures 3.4.1.1 : By FY2015 , u pdate Approaches to Safe Nanotechnology: Managing the Safety and Health Concerns As sociated with Engineered Nanomaterials.

Performance Measures 3.4.1.2 : Update the Progress R eport on the NIOSH Nanotechnology

r esearch a nd c ommunication Efforts by FY2015

.
Performance Measure 3.4.1.3 : Create new guidance documents on use of engine e ring co ntrol s , PPE , and PtD , as per Performance M easures 3.2.1.1, 3.2.1.2, 3.2.2, and 3.3.1

.
Performance Measure 3. 4.1.4 : S upport a conference on risk management of engineered n anomaterials , with a focus on engineering controls , by FY2016.

Intermediate Goal 3.5 (PPNANIG 3.5 ) : Enhance global workplace safety and healthP 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,

a pproaches, and databases could be shared.

Performance Measure 3.5 .1
. 1 : Strengthen coordination of research through government

level 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 safe ty 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.

Pe rformance 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 documen t 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

n a n o material 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 (PPNANAOG 4 .1 .1 ) : Complete the epidemiological health stu dies of U.S. workers exposed to CNTs and CNFs

.
Perfor mance Measure 4 .1
. 1 : By FY2016, complete d ata collection for industry

- wide exp osure 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 i nitiating worker exposure registries for workers exposed to existing nanomaterials ( e.g. , TiO 2 , CNT ) or producing and using new nanomaterials

.
Performance Measure 4. 1.2 : By FY2016, develop a template and begin population of worker exposure registries.

Activi ty/Output Goal 4.1 .3 (PPNANAOG4.2.3 ) : Integrate nanotechnology safety and health guidance into existing hazard surveillance systems . Determine whether these system s 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 (PPNANA OG 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 asses sments of t he controls used in ENM

- producing or

- handling facilities. BY FY2016, publish findings.
Activity/O utput 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 ad herence 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 N anotechnology Research Center , f rom Inception in 2004 t

hrough 2011 [ NIOSH 201 2 ].

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 , DH HS (NIOSH) Publication No. 201 3

- 101. It is available at http://www.cdc.gov/niosh/docs/2013

- 101/

 Current Intelligence Bulletin (CIB) 63, Occupational Exposure to Titanium Dioxide , D HHSP 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 (TiO 2 ). It is available at http://www.cdc.gov/niosh/docs/2011

- 160/

.

 A draft CIB, Occupational Exposure t o 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 s upplement to the Journal of Occupational and Environmental Med icine , 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 Rep ort 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 ) Pub lication No. 2009

– 12 5. 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 ) Pub lication 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 4 0 0 peer
- reviewed articles were publi shed between 2004 and 2 011 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 P resentations
NTRC staff will continue to deliver presentations nationally and internationally concerni ng 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 a nd 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 contro ls ) that will be used to reduce or prevent worker injury and illness from nanotechnology. R 2p 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 NIOS H NTRC is currently collaborating with a number of industries to develop appropriate engineering control s and effective administrative practices for the safe handling of nanomaterials. Specifically, t

he NTRC will continue to work with industry and labor in evaluating work place 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 li terature. The recommendations will pertain to all areas of ris k 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 Develop ment 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 scient

ists 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 stakeholder s with the goal of developing standard ized data systems for epidemiological research in workplaces producing and using nanomaterials. Through collaborations with industry, government, andP a g e | 40

DRAFT: For review purposes only. Do not cite or quote. academia, NIOSH has develop ed a “best practices” document , Approache s to Safe Nanotechnology : Managing the Health and Safety Concerns A ssociated 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 occupa tional exposure to ENMs and implement effective risk

- management practices to minimize worker exposure to ENMs

.

7 .4

. Professional O rganizations 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 strateg y for the n ation through the working group of Nanotechnology Environmental and Health Implicati ons (NEHI). NIOSH’s strategic research plan and activities have been develo ped 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 internation al 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 I nstitute of Occupational M e dicine and the H ealth and S afety L aboratory , 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 A us tralian S afety and C ompensation C ouncil (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 Co uncil on Nanotechnology (ICON) o n 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 M urashov 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 translat ed 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 o f 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 Nan opart Res 11 :1673

– 1683

. ISO [ 2008 ]

. Nanotechnologies : t erminology 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 H ealth 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 , Natio nal Institute for Occupational Safety and Health , DHHS (NIOSH) Publication No. 2007

- 123. NIOSH [ 2009 a ]. Approaches to safe nanotechnol ogy: managing the health and safety concerns associated with engineered nanomaterials

. Cincinnati, OH : U.S. Department of Health and H uman Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health , DHHS (NI OSH) Publication No. 2009

- 125

. NIOSH [2009 b ]. Interim g uidance for m edical s creening and h azard s urveillance for w orkers p otentially e xposed to e ngineered n anoparticles

. 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 Se rvices, 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 gui dance

. Cincinnati, OH : U.S. Department of Health and Human Services, Centers for Disease Control and Preve ntion , National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2010

- 105.
N IOSH [2011 ]

. Current intelligence bulletin 63: occupatio nal exposure to titanium dioxide

. Ci ncinnati, 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 [2 01 2 ]. 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. 201 3

- 101. NNI [2001]. National Nanotechnology Initiative: interagency agreement. Washington, DC: Uni ted 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]. Nanot echnology research directions for societal needs in 2020: retrospective and outlook summary

. National Science Foundation. In: Roco M, Mirkin C, Hersan M, eds. Scien c e 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 manag ement 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 engi neered 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 [ Natio nal Nanotechnology Initiative: Environmental, Health, and Safety Research S trategy. 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 t o CNT, TiO 2 , 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 exposur e 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 ENM s 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 haza rd

- 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 categor y.

 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 andP a g e | 53

DRAFT: For review purposes only. Do not cite or quote. methods to assess internal dose o f 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. Fir e 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. Reco mmendations 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. Application s  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 rel ationships between nanoparticle properties and bioactivity.

 Determine the relevance of in vitro and in vivo screening tests.

 Evaluate th e pulmonary and s ystemic effects of graphene or nanocellulose. Measurement Methods  Publish updated exposure measurement methods.

 Assist with round

- robin evaluations of ENM reference materials. Exposure Assessment  Publish e xposure r esults

.

 Provide guidance on exposure assessment methods and sampling protocols

. Epidemiology and Surveillance  Analyze biomarker samples from cross

- sectional epidemiologic study of carbon n anotube 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 n anomaterials.

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

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

 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 met als 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).