NANOTECHNOLOGY

Improved 

Performance 

Information Needed 

for Environmental, 

Health, and Safety 

Research

Report to the Chairman, Committee on 

Environment and Public Works, 

U.S. Senate

May 2012

GAO-12-427

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-427, a report to the 

Chairman, Committee on Environment and 

Public Works, U.S. Senate 

May 2012 

NANOTECHNOLOGY

Improved Performance Information Needed for 

Environmental, Health, and Safety Research

Why GAO Did This Study

Nanotechnology involves the ability to 

control matter at approximately 1 to 

100 nanometers. Worldwide trends 

suggest that products that rely on 

nanotechnology will be a $3 trillion 

market by 2020. However, some of the 

EHS impacts of nanotechnology are 

unknown. The NSTC coordinates and 

oversees the NNI, an interagency

program that, among other things,

develops national strategy documents 

for federal efforts in nanotechnology. 

In this context, GAO examined: 

(1) changes in federal funding for 

nanotechnology EHS research from 

fiscal years 2006 to 2010; (2) the 

nanomaterials that NNI member 

agencies’ EHS research focused on in 

fiscal year 2010; (3) the extent to which 

NNI member agencies collaborate with 

stakeholders on this research and 

related strategies; and (4) the extent to 

which NNI strategy documents address 

desirable characteristics of national 

strategies. GAO’s review included 

seven NNI agencies that funded 93 

percent of the EHS research dollars in 

fiscal year 2010. This report is based on 

analysis of NNI and agency documents

and responses to a questionnaire of

nonfederal stakeholders. 

What GAO Recommends

GAO recommends that the Director of 

the Office of Science and Technology 

Policy (OSTP), which administers the 

NSTC, (1) coordinate development of 

performance information for NNI EHS 

research needs and publicly report this 

information; and (2) estimate the costs 

and resources necessary to meet the 

research needs. OSTP and the seven 

included agencies neither agreed nor 

disagreed with the recommendations. 

What GAO Found

From fiscal years 2006 to 2010, the National Science and Technology Council 

(NSTC) reported more than a doubling of National Nanotechnology Initiative (NNI)

member agencies’ funding for nanotechnology environmental, health, and safety 

(EHS) research––from approximately $38 million to $90 million. Reported EHS 

research funding also rose as a percentage of total nanotechnology funding over 

the same period, ending at about 5 percent in 2010. However, GAO identified 

several reporting problems that raise concerns about the quality of EHS funding 

data reported. For example, for 18 percent of the 2010 projects GAO reviewed 

that were reported as EHS research, it was not clear that the projects were

primarily directed at EHS risks. In addition, NNI member agencies did not always 

report funding using comparable data. The absence of detailed guidance on how 

agencies should report funding for their nanotechnology research has contributed 

to these problems, as GAO also reported in 2008 and made a related 

recommendation.

In 2010, EHS research at the NNI member agencies GAO reviewed most 

frequently focused on carbon nanotubes, nanosilver, and nanoscale titanium 

dioxide. NNI has not prioritized nanomaterials for EHS research, but NNI’s 2011 

EHS research strategy outlines criteria for NNI member agencies to use in doing 

so. It is too soon to tell how these criteria will influence NNI member agencies’ 

decisions about which nanomaterials to prioritize, and it is unclear if information 

needed to use the NNI criteria is available.

The NNI member agencies have collaborated extensively on EHS research and 

strategies. They have collaborated through the NSTC to develop joint EHS 

research strategies and have initiated numerous formal collaborative EHS 

research projects. Nonfederal stakeholders who responded to GAO’s web-based 

questionnaire on nanotechnology EHS research told GAO that they benefited 

from collaboration with the NNI member agencies but identified some challenges, 

including a lack of funding and limited awareness of collaboration opportunities, 

among others. Most respondents rated the 2011 NNI EHS research strategy as 

somewhat or very effective at addressing nanotechnology EHS research needs.

NNI strategy documents for EHS research issued by the NSTC address two and 

partially address the other four of the six desirable characteristics of national 

strategies identified by GAO that offer a management tool to help ensure 

accountability and more effective results. For example, the NNI strategy 

documents provide a clear statement of purpose, define key terms, and discuss 

the quality of currently available data, among others. However, they do not 

include performance information—such as performance measures, targets, and 

time frames for meeting those measures—that would allow stakeholders to 

evaluate progress towards the goals and research needs of the NNI. In addition, 

the documents do not include, or sufficiently describe, estimates of the costs and 

resources needed for the strategy. Without this information, it may be difficult for 

agencies and stakeholders to implement the strategy and report on progress 

toward achieving the research needs and assess if investments are 

View GAO-12-427. For more information, commensurate with costs of the identified needs.

contact Frank Rusco at (202) 512-3841 or 

ruscof@gao.gov. 
Page i GAO-12-427 Nanotechnology

Letter 1 

Background 7

Funding of EHS Research by NNI Member Agencies Has Increased, 

but Quality of Funding Data Is Uncertain 15

EHS Research Funded in 2010 Focused On Metal- and CarbonBased Nanomaterials 25

NNI Member Agencies Have Collaborated Extensively on 

Nanotechnology EHS Research 31

NNI Strategy Documents Address or Partially Address Desirable 

Characteristics of National Strategies 43

Conclusion 50

Recommendations for Executive Action 51

Agency Comments and Our Evaluation 52

Appendix I Objectives, Scope, and Methodology 53

Appendix II Collaborative Nanotechnology Environmental, Health, and Safety 

Research Agreements 65

Appendix III GAO Contact and Staff Acknowledgments 78

Tables

Table 1: Program Component Areas 13

Table 2: GAO Analysis of Nanotechnology Projects Reported by 

Selected Agencies as EHS Research, Fiscal Year 2010 19

Table 3: Summary of Desirable Characteristics for a National 

Strategy 43

Table 4: Extent NNI Strategy Documents Address GAO’s Desirable 

Characteristics with Respect to Nanotechnology EHS 

Research 45

Table 5: Elements of Desirable Characteristics of National 

Strategies 61

Table 6: Collaborative Nanotechnology Environmental, Health, and 

Safety Research Agreements 66

Contents
Page ii GAO-12-427 Nanotechnology

Figures

Figure 1: The NNI Structure 11

Figure 2: Nanotechnology EHS Research Funding Reported under 

Program Component Area 7 by NSTC for All NNI Member 

Agencies, Fiscal Years 2006 through 2010 16

Figure 3: Percentage of Total NNI Research Funding Represented 

by Each Program Component Area, Fiscal Years 2006 

through 2010 17

Figure 4: Categories of Nanomaterials Studied by Seven NNI 

Member Agencies’ EHS Research Projects, Fiscal Year 

2010 25

Figure 5: Nanomaterials Studied by Seven NNI Member Agencies’ 

EHS Research Projects, Fiscal Year 2010 28

Figure 6: Usefulness of Formal Collaboration Mechanisms for 

Nanotechnology EHS Research, According to 

Questionnaire Respondents 35

Figure 7: Usefulness of Collaborative EHS Research or Related 

Activities with NNI Member Agencies, According to 

Questionnaire Respondents 36

Figure 8: Challenges to Collaboration on Nanotechnology EHS 

Research, According to Questionnaire Respondents 38

Figure 9: Effectiveness of Mechanisms for Obtaining Input on the 

NNI Strategic Planning for EHS Research, According to 

Questionnaire Respondents 39

Figure 10: Effectiveness of NNI EHS Research Strategies at 

Addressing Nanotechnology EHS Research Needs, 

According to Questionnaire Respondents 40

Figure 11: Frequency with Which Questionnaire Respondents 

Reported Obtaining Information on the Potential EHS 

Risks of Nanotechnology from NNI Member Agencies 41

Figure 12: Frequency with Which Questionnaire Respondents 

Reported Obtaining Information on the Potential EHS 

Risks of Nanotechnology from Nongovernmental Sources 42
Page iii GAO-12-427 Nanotechnology

Abbreviations

CPSC Consumer Product Safety Commission

DOD Department of Defense 

EHS environmental, health, and safety

EPA Environmental Protection Agency 

FDA Food and Drug Administration

IANH International Alliance for NanoEHS Harmonization

ICON International Council on Nanotechnology

NCI National Cancer Institute

NEHI Nanotechnology Environmental and Health Implications

NGO nongovernmental organizations

NIEHS National Institute of Environmental Health and Science

NIH National Institutes of Health

NIOSH National Institute for Occupational Safety and Health

NIST National Institute of Standards and Technology

NNCO National Nanotechnology Coordination Office

NNI National Nanotechnology Initiative

NRC National Research Council

NSET Nanoscale Science, Engineering, and Technology

NSF National Science Foundation 

NSTC National Science and Technology Council

OMB Office of Management and Budget

OSTP Office of Science and Technology Policy

PCA program component area

PCAST President’s Council of Advisors on Science and 

Technology

R&D research and development

Recovery Act American Recovery and Reinvestment Act of 2009

SAIC Science Applications International Corporation

UK United Kingdom

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-12-427 Nanotechnology

United States Government Accountability Office 

Washington, DC 20548

May 21, 2012

The Honorable Barbara Boxer

Chairman

Committee on Environment 

and Public Works

United States Senate

Dear Madam Chairman: 

Nanotechnology is the understanding and control of matter at 

approximately 1 and 100 nanometers, known as the nanoscale. For 

illustration, a sheet of paper is about 100,000 nanometers thick, a human 

hair is about 80,000 nanometers in diameter, and three gold atoms lying 

side by side are about 1 nanometer long. Unusual properties can emerge 

in materials manufactured at the nanoscale—including electrical, 

magnetic, mechanical, optical, and thermal properties—that differ in 

important ways from the properties of conventionally scaled materials. 

Materials at this scale that have been manufactured are sometimes 

referred to as engineered nanomaterials.1 Nanotechnology has enabled 

or facilitated novel research in areas such as computing, medicine, 

energy conversion and storage, water purification, agriculture and food 

systems, synthetic biology, aerospace, and geoengineering. Consumer 

products that incorporate nanotechnology are as diverse as clothing, 

cosmetics, household appliances, and sporting goods. For example, 

nanoscale particles of titanium dioxide used in sunscreens act as physical 

filters that absorb UV light without affecting the opacity of the product. A 

2010 study estimated that values for products enabled by nanotechnology 

were worth about $91 billion in the United States and $254 billion 

worldwide in 2009.

2

 

1

Nanomaterials may also occur naturally, such as components of volcanic ash or ocean 

spray, or be created incidentally, including as byproducts of welding. Our review focuses 

on engineered nanomaterials. When the term nanomaterial is used in our report, it refers 

to engineered nanomaterials.

Trends suggest that the number of nanotechnology 

products and workers employed in related fields will double every 3 years 

worldwide, achieving a $3 trillion market and 6 million workers by 2020.

2

Mihail C. Roco, Chad A. Mirkin, and Mark C. Hersam, eds., Nanotechnology Research 

Directions for Societal Needs in 2020 (Netherlands: Springer, 2010).

 
 

Page 2 GAO-12-427 Nanotechnology

Even with its increasing commercialization, much remains unknown about 

nanotechnology, including some of the environmental, health, and safety 

(EHS) impacts of nanomaterials. For example, there are few tools and 

methods—such as models to predict the behavior of nanomaterials in the 

environment—for conducting research. It is difficult to assess the risk of 

nanomaterials because these materials are too varied to generalize how 

they will behave; nonetheless, risks associated with particular uses of 

specific nanomaterials can be assessed. Further, there is little information 

on the number of workers exposed to nanomaterials in the workplace or 

the effects on human health of such exposure. However, as we reported 

in 2010, some research indicates that the toxicity of certain 

nanomaterials, such as some forms of carbon nanotubes and nanoscale 

titanium dioxide, may pose a risk to human health.3

The National Nanotechnology Initiative (NNI) is a federal interagency 

program that seeks to expedite the discovery, development, and 

deployment of nanoscale science, engineering, and technology to serve 

the public good through coordinated research and development aligned 

with the missions of its member agencies.4

 

3

GAO, Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces 

Challenges in Regulating Risk,

The NNI informs and 

influences the federal nanotechnology budget and planning process 

through its member agencies and through the National Science and 

Technology Council (NSTC), an entity administered by the Office of 

Science and Technology Policy (OSTP) that is the principal means by 

which the executive branch coordinates science and technology policy. 

The NSTC’s Committee on Technology coordinates the NNI under the 

Nanoscale Science, Engineering, and Technology (NSET) Subcommittee. 

The National Nanotechnology Coordination Office (NNCO), which reports 

to the Committee on Technology, provides technical and administrative 

GAO-10-549 (Washington, D.C.: May 25, 2010).

4

As of 2010, the NNI member agencies include the Departments of Defense, Education, 

Energy, Homeland Security, Justice, Labor, State, Treasury, and Transportation; the 

Department of Agriculture’s National Institute of Food and Agriculture and Forest Service; 

the Department of Commerce’s Bureau of Industry and Security, National Institute of 

Standards and Technology, and the U.S. Patent and Trademark Office; the Department of 

Health and Human Services’ Food and Drug Administration, National Institute for 

Occupational Safety and Health, and the National Institutes of Health; the Department of 

the Interior’s U.S. Geological Survey; the Consumer Product Safety Commission; 

Environmental Protection Agency; intelligence agencies; the International Trade 

Commission; National Aeronautics and Space Administration; Nuclear Regulatory 

Commission; National Science Foundation; Office of Management and Budget; and Office 

of Science and Technology Policy.
 

Page 3 GAO-12-427 Nanotechnology

support to the NSET. The NNI, through the NNCO and appropriate 

agencies, among others, is directed to (1) establish goals, priorities, and 

metrics for evaluation for federal nanotechnology research, development, 

and other activities; (2) invest in federal research and development 

programs in nanotechnology and related sciences to achieve these goals; 

and (3) provide for interagency coordination of federal nanotechnology 

research, development, and other activities.

The federal nanotechnology commitment is significant. Cumulative 

reported NNI funding since fiscal year 2001 amounts to more than $14 

billion. Nanotechnology research projects and activities undertaken by the 

NNI member agencies are categorized into eight program component 

areas.5

The NSTC issued three key NNI strategy documents in 2011 that, as a 

whole, seek to establish shared goals and research needs; describe NNI 

member agencies’ activities; and provide guidance for agency leaders, 

program managers, and the research community regarding planning and 

implementation of nanotechnology research and development 

investments and activities, including those related to EHS research.

Agencies report their research funding for each program 

component area to the Office of Management and Budget (OMB) as part 

of the annual federal budget process. The seventh program component 

area comprises research “primarily directed at understanding the EHS 

impacts of nanotechnology development and corresponding risk 

assessment, risk management, and methods for risk mitigation,” which 

we refer to in this report as EHS research.

6

 

5

The eight program component areas are (1) fundamental nanoscale phenomena and 

processes; (2) nanomaterials; (3) nanoscale devices and systems; (4) instrumentation 

research, metrology, and standards for nanotechnology; (5) nanomanufacturing; (6) major 

research facilities and instrumentation acquisition; (7) environment, health, and safety; 

and (8) education and societal dimensions.

Jointly, these documents form a national strategy for federal 

nanotechnology efforts—such strategies tend to cut across sectors of the 

6

These three strategy documents are: (1) NSTC, Committee on Technology, 

Subcommittee on Nanoscale Science, Engineering, and Technology, National 

Nanotechnology Initiative Strategic Plan (February 2011); (2) NSTC, Committee on 

Technology, Subcommittee on Nanoscale Science, Engineering, and Technology, 

National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy

(October 2011); and (3) NSTC, Committee on Technology, Subcommittee on Nanoscale 

Science, Engineering, and Technology, The National Nanotechnology Initiative 

Supplement to the President’s 2012 Budget (February 2011).
 

Page 4 GAO-12-427 Nanotechnology

economy and levels of government and involve a range of public and 

private organizations and entities.7

In prior work, we have identified six desirable characteristics for national 

strategies and reviewed strategies that the federal government has used 

to plan for and report on crosscutting issues including emergency 

preparedness, financial literacy, influenza, and terrorism for these 

characteristics.

The 2011 NNI strategic plan provides 

a vision and overarching goals for the program, including responsible 

development of nanotechnology, which includes EHS research. The 2011 

NNI EHS research strategy expands on the goal of the responsible 

development of nanotechnology by describing the state of science and 

research needed to ensure that nanotechnology provides maximum 

benefits to the environment and human well-being. The NNI Supplement 

to the President’s 2012 Budget serves as the annual report for the NNI 

and describes recent activities by the NNI member agencies and funding 

of the NNI, including the funding level for the program component area 

related to EHS research. These NNI strategy documents are the principal 

public record of the NSTC’s coordinating activities and reflect the NSTC’s 

guidance to agencies as they separately determine their budgets and 

activities for nanotechnology EHS research.

8

 

7

These documents also describe mechanisms for outreach and collaboration with 

stakeholders who are involved in nanotechnology EHS research, including those working 

in state and local governments, academia, companies, and nongovernmental 

organizations.

These desirable characteristics help shape the policies, 

programs, priorities, resource allocations, and standards that would 

enable federal agencies and other stakeholders to implement the 

strategies and achieve the identified results. National strategies that 

address these characteristics offer policymakers and implementing 

agencies a management tool that can help ensure accountability and 

more effective results.

8

GAO, National Capital Region: 2010 Strategic Plan is Generally Consistent with 

Characteristics of Effective Strategies, GAO-12-276T (Washington, D.C.: Dec. 7, 2011); 

Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer Federal Leadership 

Roles and an Effective National Strategy, GAO-07-781 (Washington, D.C.: Aug. 14, 

2007); Financial Literacy and Education Commission: Further Progress Needed to Ensure 

an Effective National Strategy, GAO-07-100 (Washington, D.C.: Dec. 4. 2006); Combating 

Terrorism: Evaluation of Selected Characteristics in National Strategies Related to 

Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004).
 

Page 5 GAO-12-427 Nanotechnology

In this context, you asked us to review federal nanotechnology EHS 

research. This report examines (1) changes in federal funding for 

nanotechnology EHS research from fiscal years 2006 to 2010; (2) the 

nanomaterials that NNI member agencies focused on in their EHS 

research in fiscal year 2010; (3) the extent to which NNI member 

agencies collaborate with stakeholders on nanotechnology EHS research 

and related strategies; and (4) the extent to which NNI strategy 

documents address desirable characteristics of national strategies.

To conduct this work, we reviewed EHS research efforts funded by seven 

NNI agencies, which collectively funded 93 percent of EHS research 

dollars in fiscal year 2010: the National Science Foundation (NSF), 

National Institutes of Health (NIH), Environmental Protection Agency 

(EPA), National Institute for Occupational Safety and Health (NIOSH), 

Food and Drug Administration (FDA), National Institute of Standards and 

Technology (NIST), and the Consumer Product Safety Commission 

(CPSC). The first six of these agencies represent the top six providers of 

EHS research funding from fiscal year 2006 to fiscal year 2010, and 

CPSC has an important role in ensuring the safe use of nanotechnology 

in consumer products.

To examine recent changes in federal funding for nanotechnology EHS 

research, we reviewed information published by NSTC in the NNI 

Supplements to the President’s Budget. Specifically, we reviewed funding 

reported in each program component area for fiscal years 2006 through 

2010 for all NNI member agencies funding nanotechnology research.9 For 

the dollar amounts that we adjusted for inflation, we used the Biomedical 

Research and Development Price Index to report funding in constant 

2010 dollars.10

 

9

See NSTC, Committee on Technology, Subcommittee on Nanoscale Science, 

Engineering, and Technology, The National Nanotechnology Initiative Supplement to the 

President’s 2012 Budget (February 2011); The National Nanotechnology Initiative 

Supplement to the President’s 2011 Budget (February 2010); The National 

Nanotechnology Initiative Supplement to the President’s 2010 Budget (May 2009); The 

National Nanotechnology Initiative Supplement to the President’s 2009 Budget

(September 2008); and The National Nanotechnology Initiative Supplement to the 

President’s 2008 Budget (July 2007).

We consulted with agency and OMB officials to determine 

10The Biomedical Research and Development Price Index is prepared by the Department

of Commerce, Bureau of Economic Analysis for use of and publication by NIH. Information 

about the index is available at 

http://officeofbudget.od.nih.gov/pdfs/FY13/BRDPI_Proj_Jan_2012_Final.pdf. 
 

Page 6 GAO-12-427 Nanotechnology

the type of budget information reported in these documents for the 

agencies’ investments. For fiscal year 2010, the most recent year for 

which agencies’ nanotechnology investment data were available, we also 

collected quantitative and qualitative project-level data on all research 

projects that the seven selected agencies had categorized as EHS 

research (program component area 7). The agencies do not report 

project-level data to OMB annually but report their total EHS research 

funding to OMB annually for inclusion in the NNI budget supplements 

published by NSTC. Therefore, we reviewed data on the individual 

projects included in the agencies’ total EHS research funding in 2010. To 

assess the reliability of the agencies’ data, we obtained information 

regarding the data and the information systems used to produce and 

store them. We also reviewed related supporting documentation and 

consulted with agency officials. From our assessment, we determined 

that the data were sufficiently reliable for our purposes. We analyzed 

these data and consulted with agency officials to assess whether the 

agencies had appropriately categorized as EHS research the projects 

they reported as program component area 7—research “primarily directed 

at understanding the EHS impacts of nanotechnology development and 

corresponding risk assessment, risk management, and methods for risk 

mitigation.” We also reviewed our 2008 report in this area,11 which found 

that 22 of 119 fiscal year 2006 projects reported as EHS research were 

miscategorized, and recommended that the Director of OSTP, in 

consultation with the Directors of NNCO and OMB, provide better 

guidance to agencies on how to report nanotechnology EHS research. To 

identify the nanomaterials studied by the fiscal year 2010 EHS research 

projects, we reviewed qualitative project data such as abstracts for the 

projects we determined were primarily directed at EHS and consulted with 

agency officials. We then grouped the nanomaterials into five 

categories.12

To determine the extent to which the NNI agencies collaborate with 

stakeholders on nanotechnology EHS research and related strategies, we 

(1) discussed with agency officials how their agencies collaborate on 

 

11GAO, Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of 

Federal Research Focused on Environmental, Health, and Safety Risks, GAO-08-402 

(Washington, D.C.: Mar. 31, 2008).

12The five categories are carbon-based nanomaterials, metal-based nanomaterials, 

semiconductor-based nanomaterials, organic nanomaterials, and other nanomaterials.
 

Page 7 GAO-12-427 Nanotechnology

nanotechnology EHS research and NNI’s role in facilitating that 

collaboration and (2) obtained documentation on these collaborative 

efforts. We conducted a review of formal collaborative efforts that focused 

on nanotechnology EHS research initiated from February 2008 to October 

2011. We administered a web-based questionnaire to a nonprobability 

sample of 223 nonfederal stakeholders, including those affiliated with 

academia, companies, nongovernmental organizations (NGO), and state 

and local governments, to obtain their views on collaboration with the NNI 

member agencies on EHS research and the NNI EHS research 

strategies. Of the 223, 138 completed the questionnaire, for an overall 

response rate of 62 percent. This sample included individuals who had 

expertise in the field of nanotechnology, had interacted with the NNI in the 

past few years, or who were representatives of organizations and 

companies suggested to us through our scoping interviews.

To determine the extent to which the NNI strategy documents address 

desirable characteristics of national strategies, we analyzed three key 

NNI strategy documents related to nanotechnology EHS for the presence 

of six desirable characteristics we previously identified for national 

strategies. We also reviewed NNI member agencies’ management 

documents for the use of performance information related to 

nanotechnology EHS research and the extent to which they were linked 

with the NNI national priorities. Appendix I presents a more detailed 

description of our scope and methodology.

We conducted this performance audit from February 2011 through May 

2012 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

Nanomaterials come in a variety of forms based both on their chemical 

composition and physical structure. For example, carbon-based 

nanomaterials can be produced in a number of physical structures such 

as sheets (graphene), tubes (carbon nanotubes), and particles (carbon 

black). Nanomaterials can enter the marketplace as materials 

themselves, as intermediates that either have nanoscale features or 

incorporate nanomaterials, and as final nano-enabled products.

Background
 

Page 8 GAO-12-427 Nanotechnology

The use of nanomaterials in commercial applications raises questions 

about the potential risks that might arise from exposures to nanomaterials 

and the differences in exposure during their manufacture, use, and 

disposal. For example, some, but not all, research studies have shown 

adverse respiratory or cellular effects in animals exposed to some types 

of carbon nanotubes. Observed effects include early onset and 

persistence of pulmonary fibrosis and interference with cell division.13

Efforts to examine EHS risks are complicated by the variety of 

nanomaterials available for research and commerce. According to the 

National Research Council (NRC) of the National Academies, a nonprofit 

institution providing scientific advice, there are currently gaps in 

understanding what factors or underlying phenomena contribute to 

potential hazards from nanomaterials.

The 

risk posed by a material is a combination of the hazard or negative effect 

that material may have on an organism and the extent of the organism’s 

exposure to that material. Therefore, a highly poisonous material—that is, 

one with high hazard—may nonetheless pose little risk if susceptible 

groups have little or no contact with the material. For instance, many 

household chemicals are hazardous to human health but pose little risk 

when exposure is limited by safe handling. Conversely, a material with 

relatively mild health effects may pose a large risk if people or the 

environment are exposed to large amounts or over prolonged periods.

14 In 2010, we reported that size 

alone is not a sufficient indicator of the potential risk of a material.15

 

13In this report, we did not attempt to summarize the current scientific literature on the 

potential hazards of or exposure to nanomaterials. We most recently reviewed what is 

known about the potential human health and environmental risks of nanomaterials in 

2010, see 

Research on carbon nanotubes, for example, suggests that length, purity, 

and other factors may be involved as well. Similarly, data on potential 

exposures of people and the environment are incomplete. In the absence 

of clear indicators of risk, some organizations sponsoring research on 

nanomaterials have identified specific materials or classes of materials as 

high-priority targets for EHS testing based on availability and commercial 

interest. For example, as part of a testing program of the EHS risks of 

nanomaterials, the Organisation for Economic Co-operation and 

GAO-10-549. 

14NRC, A Research Strategy for Environmental, Health, and Safety Aspects of 

Engineered Nanomaterials (2012).

15GAO-10-549. 
 

Page 9 GAO-12-427 Nanotechnology

Development has developed a list of 13 representative manufactured 

nanomaterials now or soon to be in commerce as priority testing 

targets.16,17

Regulatory agencies, like FDA, CPSC, and EPA, may not have complete 

information on the uses or risks of some nanomaterials. In 2010, we 

reported that uncertainties persist about how to evaluate the safety of 

engineered nanomaterials in food and that nanomaterials may enter the 

food supply in certain products generally recognized as safe without 

FDA’s knowledge.18 We also reported in 2010 that EPA has taken a 

variety of actions to better understand and regulate the risks of 

nanomaterials but that the agency faces challenges that might impede its 

ability to regulate nanomaterials effectively.19

 

16The Organisation for Economic Co-operation and Development is an organization of 34 

national governments, operating by consensus, that fosters dialogue among members to 

discuss, develop, and refine economic and social policies and provides an arena for 

setting rules when multilateral agreements are necessary.

For example, we reported 

that the Toxic Substances Control Act gives EPA authority to issue rules 

requiring companies to submit certain information about chemicals. EPA 

recently amended a regulation to require companies to report certain 

information regarding production of chemicals above certain thresholds 

but those thresholds may not capture nanomaterials if they are produced 

in amounts below the thresholds. EPA currently has no plans to further 

reduce the thresholds. In addition, according to officials at CPSC, which is 

charged with protecting the public from unreasonable risks of injury or 

death from thousands of types of consumer products, CPSC does not 

have the statutory authority to require pre-market approval for products,

including those incorporating nanomaterials.

17The nanomaterials the Organisation for Economic Co-operation and Development 

selected are fullerenes, single-walled carbon nanotubes, multi-walled carbon nanotubes, 

silver nanoparticles, iron nanoparticles, titanium dioxide, aluminum oxide, cerium oxide, 

zinc oxide, silicon dioxide, dendrimers, nanoclays, and gold nanoparticles.

18GAO, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients 

Determined to Be Generally Recognized as Safe (GRAS), GAO-10-246 (Washington, 

D.C.: Feb. 3, 2010). Subsequent to this report, FDA issued draft guidance on April 20, 

2012, on assessing the effects of significant manufacturing changes, including any 

involving nanotechnology, on the identity, safety, or regulatory status of food substances. 

19GAO-10-549. 
 

Page 10 GAO-12-427 Nanotechnology

The NNI was codified in law by the 21st Century Nanotechnology 

Research and Development Act in 2003.20

 

20Pub. L. No. 108-153 (2003).

The act requires the President 

to implement a national nanotechnology program and charges the NSTC 

itself—or through a subgroup—with overseeing the planning, 

management, and coordination of the program. The NSTC carries out 

these tasks through the NSET Subcommittee, which includes a co-chair 

from OSTP as well as representatives from the member agencies of the 

NNI. The NSET oversees working groups, including the Nanotechnology 

Environmental and Health Implications (NEHI) working group which 

supports federal activities to protect public health and the environment. 

Figure 1 provides an overview of the organizational structure of the NNI.
 

Page 11 GAO-12-427 Nanotechnology

Figure 1: The NNI Structure

The NNI does not fund research directly; rather, each of its member 

agencies determines its nanotechnology activities based on its individual 

mission and priorities. The NNI provides a framework for a 

comprehensive nanotechnology research and development program by 

establishing shared goals, priorities, and strategies among member 

agencies; and providing avenues for member agencies to leverage the 

resources of all participating agencies. The four goals of the NNI are to 

(1) advance a world-class nanotechnology research and development 

program; (2) foster the transfer of new technologies into products for 
 

Page 12 GAO-12-427 Nanotechnology

commercial and public benefit; (3) develop and sustain educational 

resources, a skilled workforce, and the supporting infrastructure and tools 

to advance nanotechnology; and (4) support responsible development of 

nanotechnology.

Efforts of the NNI member agencies are reported through triennial 

strategic plans and annual budget supplements. The act directs the 

NSTC, itself or through an appropriate subgroup it designates or 

establishes, to develop and update every 3 years a strategic plan to guide 

the activities of the program. The NSTC published its most recent 

strategic plan in February 2011.21 In addition to the statutorily required 

strategic plan, in 2008, the NSTC published a Strategy for 

Nanotechnology-Related Environmental, Health, and Safety Research 

and updated this document in 2011.22 The EHS strategies published in 

2008 and 2011 expand on the goal of the responsible development of 

nanotechnology by describing the state of science and research needed 

to ensure that nanotechnology provides maximum benefits to the 

environment and human well-being. The act also requires the NSTC to 

prepare an annual report to be submitted to congressional committees on 

the national nanotechnology program’s budget and an analysis of the 

progress made toward achieving the goals and priorities established for 

the program, among other things. In the NNI Supplements to the 

President’s Budget, the NSTC reports overall NNI spending and 

describes research efforts and investments within eight program 

component areas, as seen in table 1. These program component areas 

provide an organizational framework for categorizing the activities of the 

NNI. Data presented in the NNI annual supplements is collected from the 

NNI member agencies by OMB as part of the annual budget formulation 

process.

 

21NSTC, Committee on Technology, Subcommittee on Nanoscale Science, Engineering, 

and Technology, National Nanotechnology Initiative Strategic Plan (February 2011).

22NSTC, Committee on Technology, Subcommittee on Nanoscale Science, Engineering, 

and Technology, National Nanotechnology Initiative Strategy for Nanotechnology-Related 

Environmental, Health, and Safety Research (February 2008) and National 

Nanotechnology Initiative Environmental, Health, and Safety Research Strategy (October 

2011).
 

Page 13 GAO-12-427 Nanotechnology

Table 1: Program Component Areas

No. Title Description

1 Fundamental Nanoscale 

Phenomena and Processes

Discovery and development of fundamental knowledge pertaining to new phenomena in 

the physical, biological, and engineering sciences that occur at the nanoscale. Elucidation 

of scientific and engineering principles related to nanoscale structures, processes, and 

mechanisms. 

2 Nanomaterials Research aimed at the discovery of novel nanoscale and nanostructured materials and at a 

comprehensive understanding of the properties of nanomaterials (ranging across length 

scales, and including interface interactions). Research and development (R&D) leading to 

the ability to design and synthesize, in a controlled manner, nanostructured materials with 

targeted properties.

3 Nanoscale Devices and Systems R&D that applies the principles of nanoscale science and engineering to create novel, or to 

improve existing, devices and systems. Includes the incorporation of nanoscale or 

nanostructured materials to achieve improved performance or new functionality. To meet 

this definition, the enabling science and technology must be at the nanoscale, but the 

systems and devices themselves are not restricted to that size.

4 Instrumentation Research, 

Metrology, and Standards for 

Nanotechnology

R&D pertaining to the tools needed to advance nanotechnology research and 

commercialization, including next-generation instrumentation for characterization, 

measurement, synthesis, and design of materials, structures, devices, and systems. Also 

includes R&D and other activities related to development of standards, including standards 

for nomenclature, materials characterization and testing, and manufacture.

5 Nanomanufacturing R&D aimed at enabling scaled-up, reliable, and cost-effective manufacturing of nanoscale 

materials, structures, devices, and systems. Includes R&D and integration of ultraminiaturized top-down processes and increasingly complex bottom-up or self-assembly 

processes.

6 Major Research Facilities and 

Instrumentation Acquisition

Establishment of user facilities, acquisition of major instrumentation, and other activities 

that develop, support, or enhance the nation’s scientific infrastructure for the conduct of 

nanoscale science, engineering, and technology R&D. Includes ongoing operation of user 

facilities and networks.

7 Environment, Health, and Safety Research primarily directed at understanding the environmental, health, and safety impacts 

of nanotechnology development and corresponding risk assessment, risk management, 

and methods for risk mitigation.

8 Education and Societal 

Dimensions

Education-related activities such as development of materials for schools, undergraduate 

programs, technical training, and public communication, including outreach and 

engagement. Research directed at identifying and quantifying the broad implications of 

nanotechnology for society, including social, economic, workforce, educational, ethical, and 

legal implications.

Source: NSTC, 2011 NNI Strategic Plan.

The act requires triennial external reviews of the national nanotechnology 

program. Specifically, the act requires the NNCO to contract with the 

NRC to conduct the triennial evaluations of the national nanotechnology 

program. The NRC draws on expertise from outside government, 

including from academia, companies, and NGOs. The NRC completed 

reviews in 2002, 2006, and 2009 based on the work of 15 to 23 panelists 

chosen by the NRC and identified in the review. In addition, the NRC also 
 

Page 14 GAO-12-427 Nanotechnology

published an independent research strategy to address EHS aspects of 

nanomaterials in 2012.23

The act also requires the President to establish or designate a National 

Nanotechnology Advisory Panel. The advisory panel, by statute, must 

consist primarily of members from academic institutions and industry, and 

panel members must be qualified to provide advice and information on 

nanotechnology research, development, demonstrations, education, 

technology transfer, commercial application, or societal and ethical 

concerns. Since 2004, the President has designated the President’s 

Council of Advisors on Science and Technology (PCAST) to function as 

the advisory panel. PCAST members are generally senior managers in 

major corporations and academia selected for diverse expertise in 

science and technology issues. The advisory panel is required to report 

not less frequently than once every 2 fiscal years on its assessment of the 

national nanotechnology program and recommendations for ways to 

improve the program. The advisory panel has produced three 

assessments to date, in 2005, 2008, and 2010. The first and second 

assessments were authored by a subset of PCAST membership, and the 

third assessment was authored by a working group of three PCAST 

members and additional external experts, but PCAST as a whole 

approved the assessments. The first and second assessments created 

Nanotechnology Technical Advisory Groups, which were comprised of 

approximately 40 members who provided written responses to 

questionnaires developed by PCAST. The membership of these groups is 

not identified in the assessments. The external members of the third 

assessment’s working group were selected by PCAST members and are 

identified in PCAST’s assessment.24

 

23NRC, A Research Strategy for Environmental, Health, and Safety Aspects of 

Engineered Nanomaterials (2012). We did not fully evaluate this strategy in the context of 

federal EHS research efforts because it was issued in draft form in January 2012.

24The working group invited additional experts to speak at public meetings, including 

individuals working in academia and the corporate sector.
 

Page 15 GAO-12-427 Nanotechnology

NSTC reported more than a doubling of funding for nanotechnology EHS 

research by NNI member agencies from fiscal years 2006 to 2010.25

Reported EHS funding also rose as a percentage of total NNI funding 

during this period, ending up at about 5 percent in 2010. We also 

identified several reporting problems related to the continued absence of 

detailed guidance on how agencies should report funding for their 

nanotechnology research, raising concerns about the quality of EHS 

funding data reported.

From fiscal years 2006 to 2010, NSTC reported more than a doubling of 

NNI member agencies’ funding for nanotechnology EHS research in the 

NNI Supplements to the President’s Budget––from approximately $38 

million26 to $90 million.27

 

25This includes funding by the seven agencies we selected (CPSC, EPA, FDA, NIH, 

NIOSH, NIST, and NSF) as well as by the other NNI members funding nanotechnology 

EHS research (the Departments of Defense, Energy, and Agriculture).

 As shown in figure 2, most of this funding was 

reported to be by NSF, NIH, and EPA, and the largest increases in 

reported EHS research funding over this period were at NIH and EPA.

26Adjusted for inflation, the amount of nanotechnology EHS research funding NSTC 

reported for fiscal year 2006 was approximately $43 million, in 2010 dollars.

27This includes funding by the seven agencies we selected as well as by the other NNI 

members funding nanotechnology EHS research.

Funding of EHS 

Research by NNI 

Member Agencies Has 

Increased, but Quality 

of Funding Data Is 

Uncertain

EHS Research Funding by 

NNI Member Agencies 

More Than Doubled From 

2006 to 2010 and 

Amounted to About 5 

Percent of Total NNI 

Funding in 2010
 

Page 16 GAO-12-427 Nanotechnology

Figure 2: Nanotechnology EHS Research Funding Reported under Program 

Component Area 7 by NSTC for All NNI Member Agencies, Fiscal Years 2006 

through 2010

Note: This figure does not include research NSTC separately reported as funded by the American 

Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. No. 111-5 (2009)). The Recovery 

Act was enacted to, among other things, preserve and create jobs and promote economic recovery. 

For fiscal year 2009, NSTC reported additional funding for EHS research funded by the Recovery Act, 

as follows: NSF, $3.4 million; NIH, $8.4 million; and Department of Energy, $0.2 million. For fiscal 

year 2010, NSTC did not separately report nanotechnology funding from Recovery Act 

appropriations. 

a

The NNI Supplements to the President’s Budget did not include nanotechnology funding data for 

CPSC and FDA prior to fiscal year 2009. 

Figure 3 shows the percentage of NNI funding represented by each 

program component area (PCA) for all NNI member agencies funding 

nanotechnology research. Most of the funding reported was for PCA 1 

(fundamental nanoscale phenomena and processes), PCA 2 

(nanomaterials), and PCA 3 (nanoscale devices and systems). Reported 

EHS funding rose as a percentage of total NNI funding from fiscal years 
 

Page 17 GAO-12-427 Nanotechnology

2006 to 2010, ending up at about 5 percent in 2010. Specifically, for fiscal 

year 2010, funding for EHS research was $90 million, while total 2010 

nanotechnology funding was $1.9 billion, as reported in the NNI 

Supplement to the President’s 2012 Budget.

Figure 3: Percentage of Total NNI Research Funding Represented by Each Program 

Component Area, Fiscal Years 2006 through 2010

Notes: This figure includes funding by the seven agencies we selected (CPSC, EPA, FDA, NIH, 

NIOSH, NIST, and NSF) as well as by the other NNI member agencies funding nanotechnology 

research (the National Aeronautics and Space Administration and the Departments of Defense, 

Energy, Agriculture, Justice, Homeland Security, and Transportation). 

This figure does not include research NSTC separately reported as funded by the Recovery Act. For 

fiscal year 2009, NSTC reported an additional $511 million for activities funded by the Recovery Act, 

as follows: PCA 1, $131 million; PCA 2, $178 million; PCA 3, $68 million; PCA 4, $12 million; PCA 5, 

$29 million; PCA 6, $73 million; PCA 7, $12 million; and PCA 8, $9 million. For fiscal year 2010, 

NSTC did not separately report agencies’ funding from the Recovery Act appropriations. 
 

Page 18 GAO-12-427 Nanotechnology

Based on our review of the NNI member agencies’ EHS research funding 

data published by NSTC in the NNI Supplements to the President’s 

Budget and detailed project data we obtained from the seven selected 

agencies for fiscal year 2010, we identified several reporting problems 

that raise concerns about the accuracy, consistency, and completeness 

of funding data reported and make it difficult to assess changes in federal 

funding for nanotechnology EHS research over time. We found that (1) for 

18 percent of 2010 projects reported as EHS research, it was not clear 

that the projects were primarily directed at EHS risks; (2) agencies vary in 

how they report funding for portions of projects that address multiple 

program component areas or include non-nanotechnology research; (3) 

agencies did not always report comparable budget data; and (4) NNI 

does not report updated data after publication of the NNI budget 

supplements, and the reported data may not reflect all EHS funding.

Of the 236 projects that the seven agencies reported to us as EHS 

research for fiscal year 2010, we determined that, for 43 projects (18 

percent), it was not clear that the projects met the definition for PCA 7—

research primarily directed at the EHS impacts of nanotechnology 

development and corresponding risk assessment, risk management, and 

methods for risk mitigation. As shown in table 2, these projects, 20 of 

which were funded by NSF, accounted for approximately $15 million of 

the reported EHS funding. NSF officials told us that the agency reported 

projects as EHS research if they had some relevance to EHS instead of 

reporting only those projects primarily directed at EHS.

We also found that, for some projects reported by other agencies, 

studying EHS risks was not the primary purpose of the projects. Instead, 

some projects focused on, for example, exploring how nanotechnology 

could be used in various applications, such as remediation of 

environmental contamination, detection of chemical hazards or 

pathogens, or medical imaging. In addition, some other projects included 

some research relevant to understanding EHS impacts of 

nanotechnology, but it was not clear that the study of EHS issues was the 

primary purpose. For example, some projects studied various 

nanotechnology-enabled drugs, but it was not clear to what extent the 

research was directed at the safety of the drugs versus their efficacy. 

Other projects were directed at instrumentation and nanotechnology 

measurement issues that had some relevance for EHS research, but it 

was not clear whether these should be reported as PCA 7 (EHS 

research) or PCA 4 (instrumentation research, metrology, and standards 

for nanotechnology).

Reporting Problems Raise 

Concerns about Quality of 

EHS Research Funding 

Data

Eighteen Percent of Projects 

Reported as EHS Research 

Were Not Clearly Directed at 

EHS Risks
 

Page 19 GAO-12-427 Nanotechnology

Table 2: GAO Analysis of Nanotechnology Projects Reported by Selected Agencies as EHS Research, Fiscal Year 2010 

GAO analysis of agencies’ projects

Projects seven agencies reported 

to GAO as EHS research Primarily directed at EHS 

Not clear that projects were 

primarily directed at EHS 

Agency Numbera

Funding

(dollars in 

millions) Number

Funding 

(dollars in 

millions) Number

Funding 

(dollars in 

millions)

CPSC 8 $0.5 8 $0.5 0 $0 

EPAb 32 17.6c 29 16.9 3 0.8

FDA 29d 5.3c 20 3.8 9 1.5

NIH 58 27.7e 55 26.4f 3 1.3g

NIOSH 49 9.8h 47 9.7 2 0.1 

NIST 11 3.4 5 1.6 6 1.8

NSF 49 27.1 29 17.1 20 10.0

Totali 236 $91.4j 193 $76.0 43 $15.5

Source: GAO analysis of obligations data reported to us by seven agencies.

Notes: The data shown in this table may differ from that reported by NSTC in the NNI Supplement to 

the President’s 2012 Budget, as described below. 

a

For some projects at NIH, NIOSH, and NIST, we grouped together some of the agencies’ data 

entries and counted them together for the purposes of our analyses. Consequently, the numbers of 

projects reported here may not match the number reported by these agencies elsewhere. Appendix I 

presents more details on how we grouped projects at these agencies. 

b

According to an EPA official, the total EHS research funding reported to us for fiscal year 2010 

represents actual obligations, but the amounts reported for individual projects are estimates. 

c

The total for this agency differs from that reported by NSTC in the NNI Supplement to the President’s 

2012 Budget because the agency reported its budget authority to OMB for the budget supplement 

and reported obligations to us. 

d

FDA reported a total of 30 EHS research projects to us; however, for one of those projects, FDA 

reported that no funds were obligated in fiscal year 2010. Therefore, we excluded that project from 

our analysis. 

e

The total for this agency differs from that reported by NSTC in the NNI Supplement to the President’s 

2012 Budget because NIH included in the data reported to us its fiscal year 2010 obligations of funds 

appropriated by the Recovery Act, which it did not report to OMB for the supplement. 

f

We added $35,044 to NIH’s reported total because we identified additional funding for a subproject 

that we determined should have been included. NIH officials told us that the sub-project was not 

included because the project abstract and other associated text did not contain any of the key words 

for the computerized search of projects that NIH uses to develop its list of EHS research. 

g

For two additional NIH projects, we found that the amount of funding for research primarily directed 

at EHS was overstated. For each of these projects, NIH included the funding for one or more 

subprojects that were not focused on nanotechnology. We included the overstated amounts in the 

dollar value for projects where it was not clear that the research was primarily directed at EHS. 

h

The total for this agency differs from that reported by NSTC in the NNI Supplement to the President’s 

2012 Budget because NIOSH updated its data after initially reporting it to OMB. 

i

Totals may not add because of rounding. 

j

The total dollar value of $91.4 million reported to us differs from the total of $90.2 million reported by 

NSTC in the NNI Supplement to the President’s 2012 Budget for two reasons. First, this table 

includes only the seven agencies we reviewed, not all agencies that funded EHS research in 2010. 

Second, four of the seven agencies we reviewed reported data to us that differed from those reported 

by NSTC. 
 

Page 20 GAO-12-427 Nanotechnology

As previously noted, we recommended in our 2008 report that the 

Director of OSTP, in consultation with the Directors of NNCO and OMB, 

provide better guidance to agencies on how to report nanotechnology 

EHS research.28 OSTP generally concurred with the report’s findings and 

agreed to review the manner in which agencies respond to the current 

guidance. However, we found that as of February 2012, updated 

guidance had not been issued, and the definition of each program 

component area as documented in OMB Circular A-11 remained the only 

written guidance available to the agencies for reporting their 

nanotechnology EHS research.29

NNCO and FDA officials told us that the reporting of EHS research was a 

regular agenda item at meetings of the NEHI working group during 

development of the 2011 NNI EHS research strategy. However, the 

strategy used information reported via a different OMB data call, one that 

NNCO and OMB officials said was much more detailed and cast a 

broader net than the annual nanotechnology data calls OMB conducts for 

the annual NNI budget supplements (the “crosscut”). The 21st Century 

Nanotechnology Research and Development Act requires annual 

reporting of spending for each program component area, and the crosscut 

collects EHS research funding data based on the definition of PCA 7—

research primarily directed at the EHS impacts of nanotechnology 

OMB Circular A-11 does not address 

what types of projects should or should not be categorized as EHS 

research, such as how to determine if a project is “primarily” directed at 

EHS impacts or how to report projects focused on environmental or 

health-related applications of nanotechnology. For example, with respect 

to drugs, HHS commented that the Federal Food, Drug, and Cosmetic 

Act requires that both safety and effectiveness be evaluated, in relation to 

one another. As HHS noted, both traits are relevant to the overall health 

impact of a drug product. However, OMB Circular A-11 does not address 

whether funding for research on the effectiveness of nanotechnologyenabled drugs should be considered nanotechnology EHS research 

under the definition of PCA 7. It also does not address how to report 

EHS-related projects that are focused on instrumentation and metrology, 

and we found that agencies have used different criteria to determine the 

program component area under which to report such projects as well.

 

28GAO-08-402. 

29OMB Circular No. A-11, Preparation, Submission, and Execution of the Budget, pt. 2, § 

84 (July 2010).
 

Page 21 GAO-12-427 Nanotechnology

development and corresponding risk assessment, risk management, and 

methods for risk mitigation. However, the data call for the 2011 research 

strategy was, according to OMB’s instructions to agencies, “not limited to 

research and development efforts whose primary purpose is to 

understand and address potential risks to health and to the environment 

posed by this technology—as is called for in the overall crosscut for 

nanotechnology.” Consequently, discussions of how to report projects for 

use in developing the 2011 research strategy do not necessarily provide 

guidance to agencies on how to determine whether their research meets 

the definition of PCA 7, or how to apportion funding for projects that 

address multiple program component areas.

In our 2008 report, we found that neither NSET nor OMB had provided 

guidance on whether or how to apportion funding for a single research 

project to more than one program component area, if appropriate.30

At NIOSH, agency officials told us that, for projects that include nonnanotechnology research, they track and report the nanotechnology 

In this 

review, we found that agencies have different approaches to reporting 

funding for projects that address multiple program component areas or 

include non-nanotechnology research, and the guidance available to the 

agencies—the PCA definitions in OMB Circular A-11—still does not 

address this. We found that, for fiscal year 2010 projects where only a 

portion of the project was focused on nanotechnology EHS research, 

NIST and NSF assigned only a portion of the total funding to PCA 7. At 

NIH, grants or contracts may be either single projects or multiproject 

“parent” grants or contracts, which have multiple individual subprojects. 

According to NIH officials, NIH policy does not allow the funding for a 

single project or subproject to be subdivided across program component 

areas, and NNI policy requires that the individual totals of the program 

component areas sum to the agency’s total nanotechnology funding. As a 

consequence of these two policies, if a grant or contract is a single 

project, then NIH reports the entire value of the individual grant or 

contract in only one program component area. NIH officials told us that if 

a grant or contract has subprojects, NIH reports the funding for an 

individual subproject in only one program component area, but the 

funding for the different subprojects can be reported in different program 

component areas, as applicable.

 

30GAO-08-402. 

Agencies Vary in How They 

Report Funding for Portions 

of Projects
 

Page 22 GAO-12-427 Nanotechnology

research portions separately and that the agency reports all of its 

nanotechnology research as EHS because NIOSH’s mission aligns with 

PCA 7. The NIOSH mission includes conducting research on the potential 

implications of nanotechnology on worker health and safety, as well as 

conducting research on potential applications of nanotechnology to solve 

worker health and safety problems. FDA officials also told us that they 

report all of their regulatory science research regarding nanotechnology 

as EHS because it is conducted to support the agency’s mission, which 

they said aligns with PCA 7. As described in FDA’s Strategic Priorities

document, the agency’s mission includes ensuring both the safety and 

the effectiveness of drugs, biological products, and medical devices, as 

well as the safety of foods and cosmetics.31

Data on nanotechnology funding published in the annual NNI 

Supplements to the President’s Budget are not comparable over time or 

across agencies because the data do not always represent the same type 

of budget information. The NNI budget supplements report funding as 

“actual agency investments” but do not specify what type of data are 

reported as actual agency investments, and until recently, OMB’s 

instructions to agencies for providing these data did not specify what 

should be reported.32 Officials from OMB told us that agencies report 

budget authority for their actual agency investments,33

 

31FDA, Strategic Priorities 2011-2015.

but officials from 

the seven agencies we reviewed generally told us that they had reported 

obligations as their actual agency investments for fiscal years 2006 to 

32OMB’s data calls for 2007 to 2009 actual agency investments did not specify what type 

of budget data should be reported; the data call for 2010 data asked agencies to report 

budget authority for their actual agency investments.

33Budget authority is authority provided by federal law to enter into financial obligations 

that will result in immediate or future outlays involving federal government funds. Budget 

authority includes (1) appropriations, (2) borrowing authority, (3) contract authority, and (4) 

authority to obligate and expend offsetting receipts and collections. Appropriations 

represent budget authority to incur obligations and make payments from the Treasury for 

specified purposes. Appropriations do not represent cash actually set aside in the 

Treasury for purposes specified in the appropriation act; they represent amounts that 

agencies may obligate during the period of time specified in the respective appropriation 

acts. See GAO, A Glossary of Terms Used in the Federal Budget Process, 

GAO-05-734SP (Washington, D.C.: Sept. 1, 2005).

Agencies Did Not Always 

Report Comparable Budget 

Data
 

Page 23 GAO-12-427 Nanotechnology

2010.34

Funding data published by NSTC in the NNI Supplements to the 

President’s Budget are not always final because agencies sometimes 

make changes to their data after they are published as actual agency 

investments in the budget supplements. Consequently, outdated data can 

remain available in NNI documents and on the NNI website, which 

publishes nanotechnology research funding data from the budget 

supplements in response to OMB’s 2009 Open Government Directive.

However, an agency’s budget authority and obligations are not 

always the same amounts in a given year. Furthermore, agencies may 

not always report the same type of budget information from year to year. 

For example, for fiscal year 2009, FDA reported obligations, but then 

reported budget authority for fiscal year 2010 because obligations data 

were not available, according to FDA officials.

35

 

34Obligations are definite commitments that create a legal liability of the government for 

the payment of goods and services ordered or received, or a legal duty on the part of the 

United States that could mature into a legal liability by virtue of actions on the part of the 

other party beyond the control of the United States. Payment may be made immediately or 

in the future. An agency incurs an obligation, for example, when it places an order, signs a 

contract, awards a grant, purchases a service, or takes other actions that require the 

government to make payments to the public or from one government account to another. 

See 

For example, NIOSH officials told us that their fiscal year 2010 actual 

agency investment in EHS research reported in the NNI Supplement to 

the President’s 2012 Budget was an estimate because the timing of 

OMB’s call for the data was earlier than usual. According to NIOSH 

officials, a second data call occurred later in the fiscal year, at which time 

the agency was able to report an accurate actual funding level. However, 

as of February 2012, NIOSH’s estimated data have not been updated on 

the NNI website. In addition, we found that when NIST reported its 2009 

nanotechnology research funding from the American Recovery and 

Reinvestment Act of 2009 (Recovery Act) ($43.4 million), this was an 

estimate, and the funding was actually obligated over 2 years ($6 million 

obligated in fiscal year 2009, and $37.4 million obligated in fiscal year 

2010). However, as of February 2012, NIST’s estimated data have not 

been updated on the NNI website.

GAO-05-734SP. 

35As directed in the President’s Memorandum on Transparency and Open Government 

issued on January 21, 2009, OMB issued an Open Government Directive instructing 

executive branch agencies to, among other things, publish government information online.

NNI Does Not Report Updated 

Data after Publication of 

Budget Supplements, and 

Reported Data May Not Reflect 

All EHS Funding
 

Page 24 GAO-12-427 Nanotechnology

In some instances, the reported data may not reflect all EHS research 

funding. We found that the fiscal year 2010 data reported by NSTC in the 

NNI Supplement to the President’s 2012 Budget did not include all 2010 

nanotechnology funding from Recovery Act appropriations, and OMB did 

not request that information from agencies in its call for 2010 data.36 We 

found that NIH,37 NIST,38 and NSF39 together obligated a total of $131.2 

million for nanotechnology research in 2010 with Recovery Act 

appropriations (including $8 million for EHS research by NIH).40 However, 

while NSF included its Recovery Act funds in the funding reported in the 

NNI Supplement to the President’s 2012 Budget, NIH and NIST did not. 

In addition, some EHS research funding may not be included in the 

budget supplements because of agency-specific reporting methods.41

 

36However, the NNI Supplement to the President’s 2011 Budget did include data on 2009 

actual agency investments from Recovery Act appropriations.

37NIH officials told us that, for fiscal year 2010, NIH obligated funds appropriated by the 

Recovery Act as follows: PCA 1, $19.8 million; PCA 2, $15.6 million; PCA 3, $28.3 million; 

PCA 4, $3.9 million; PCA 7, $8 million; and PCA 8, $0.5 million. 

38NIST officials told us that, for fiscal year 2010, NIST obligated funds appropriated by the 

Recovery Act as follows: PCA 5, $3.1 million; and PCA 6, $34.3 million. 

39NSF officials told us that, for fiscal year 2010, NSF obligated $17.7 million for PCA 6 

research with funds appropriated by the Recovery Act. 

40We did not determine the amounts of 2010 investments from Recovery Act 

appropriations, if any, by the NNI member agencies funding nanotechnology research that 

were not included in this review (the National Aeronautics and Space Administration and 

the Departments of Defense, Energy, Agriculture, Justice, Homeland Security, and 

Transportation). 

41For example, according to NIOSH officials, the agency does not report to OMB funds 

that provide support for major program areas that require shared services and facilities, 

because of the difficulty of placing portions of a central support project into a program 

component area. Also, the automated method NIH uses to compile its list of 

nanotechnology EHS research projects may not identify all appropriate projects because it 

relies on a computerized search of key words, which will not define an absolute dividing 

line between projects that should be included in the EHS program component area and 

those that should not. According to NIH officials, this process provides a consistent, 

reliable, and repeatable method for efficiently scanning NIH’s projects, which number 

more than 50,000 annually. We did not review information on NIH projects that were not 

reported to us by NIH as nanotechnology EHS research. However, in reviewing 

information on the 58 fiscal year 2010 nanotechnology EHS research projects NIH 

reported to us, we identified one example of funding for a subproject that was missed by 

this method. 
 

Page 25 GAO-12-427 Nanotechnology

In fiscal year 2010, EHS research at the seven NNI member agencies we 

reviewed focused on two categories of nanomaterials more than others—

metal- and carbon-based nanomaterials, which are used in a variety of 

applications, including electronics, consumer products such as 

sunscreens, medical products, and protective coatings (see fig. 4). NNI 

has not prioritized nanomaterials for EHS research, but in October 2011 it 

outlined criteria for its member agencies to use in doing so. It is not yet 

clear what effect these criteria will have on how agencies prioritize the 

nanomaterials they focus on in their EHS research.

Figure 4: Categories of Nanomaterials Studied by Seven NNI Member Agencies’ EHS Research Projects, Fiscal Year 2010

Notes: The figure is based upon our analysis of the 193 projects we determined were primarily 

directed at EHS. It does not include the 43 projects for which it was not clear to us that the research 

was primarily directed at EHS. The numbers of projects shown do not total 193 because projects 

often targeted more than one category of nanomaterials. 

a

Metal-based nanomaterials consisted of silver, gold, iron-based nanomaterials, various metal oxides 

(titanium, zinc, cerium, and aluminum oxides), and other metal-based nanomaterials. 

b

Carbon-based nanomaterials consisted of carbon nanotubes, fullerenes, and other carbon-based 

nanomaterials. Spherical and ellipsoidal carbon nanomaterials are referred to as fullerenes, while 

cylindrical ones are called nanotubes. 

c

Semiconductor-based nanomaterials consisted of quantum dots, silicon-based nanomaterials, and 

other semiconductor-based nanomaterials. Quantum dots are closely packed semiconductor crystals 

composed of hundreds or thousands of atoms. 

d

Examples of projects not targeted to particular nanomaterials are projects that funded large research 

centers on the environmental implications of nanotechnology, or projects that purchased data on the 

market for nanomaterials in order to guide exposure assessment studies by providing information on 

potential consumer exposures. 

e

Organic nanomaterials consisted of dendrimers, other polymers, and other organic-based 

nanomaterials. Dendrimers are branched nanosized polymers. The surface of a dendrimer has 

numerous chain ends, which can be tailored to perform specific chemical functions. 

f

Other nanomaterials consisted solely of nanoclays (one project). 

EHS Research 

Funded in 2010 

Focused On Metaland Carbon-Based 

Nanomaterials
 

Page 26 GAO-12-427 Nanotechnology

As shown in figure 5, we found that in the 193 fiscal year 2010 research 

projects we determined were primarily directed at EHS, the nanomaterials 

that were most frequently the focus of this research were carbon 

nanotubes (70 projects), nanosilver (60 projects), and nanoscale titanium 

dioxide (48 projects).42

• Carbon nanotubes are nanoscale cylinders consisting of seamlessly 

“rolled” sheets of graphene, a form of carbon. They are extraordinarily 

strong, flexible, lightweight, heat resistant, and have high electrical 

conductivity. Carbon nanotubes are currently used in a variety of 

applications including conductive coatings for touchscreens and solar 

cells, and sporting goods such as bicycle frames and baseball bats. 

According to a 2009 NIOSH report, carbon nanotubes have been 

shown to produce adverse effects in the respiratory systems of rats.43

• Nanosilver is a metal-based nanomaterial that, according to a 2010 

EPA report, is currently used in an increasing number of consumer 

and medical products because of its remarkably strong antimicrobial 

properties.44

 

42The numbers of projects do not total 193 because (1) some projects targeted 

nanomaterials other than carbon nanotubes, nanosilver, and nanoscale titanium dioxide; 

(2) projects often targeted multiple nanomaterials; and (3) nineteen of the 193 projects 

were not targeted to particular nanomaterials. For example, some projects not targeted to 

particular nanomaterials funded large research centers on the environmental implications 

of nanotechnology; others purchased data on the market for nanomaterials to guide the 

agency’s exposure assessment studies by providing information on the potential 

consumer exposures. 

For example, EPA reported that nanosilver is being 

incorporated into clothing, food contact materials such as packaging 

and cutting boards, household appliances, cosmetics, and children’s 

toys. It is also used in industrial processes because of its ability to 

catalyze many reactions. According to EPA’s 2010 report, there is 

clear evidence that nanosilver is toxic to aquatic and terrestrial 

organisms and may be detrimental to human health. In this report, 

EPA noted that several studies have shown that nanosilver can be 

released into the wastewater stream during washing, such as from 

socks containing nanosilver. The nanosilver released may disrupt the 

43NIOSH, Approaches to Safe Nanotechnology: Managing the Health and Safety 

Concerns Associated with Engineered Nanomaterials, Department of Health and Human 

Services (NIOSH) Publication No. 2009–125 (March 2009).

44EPA, State of the Science Literature Review: Everything Nanosilver and More, 

EPA/600/R-10/084 (August 2010).

2010 Research Focused on 

Carbon Nanotubes, Silver, 

and Titanium Dioxide
 

Page 27 GAO-12-427 Nanotechnology

helpful bacteria used in wastewater treatment processes or be 

released into the environment.

• Nanoscale titanium dioxide is a metal-based nanomaterial used in 

sunscreens, protective coatings, and other materials to manage heat 

and light by blocking UV light from the sun’s rays. It is also being 

added to paints, cements, windows, tiles, and other products for its 

sterilizing and deodorizing properties and is being used for antifogging 

coatings and self-cleaning windows. In addition, it is being 

investigated for use in removing contaminants from drinking water. 

According to a 2011 NIOSH report, nanoscale titanium dioxide is a 

potential occupational carcinogen when inhaled.45 Regarding 

exposure to this nanomaterial in sunscreens, a 2010 FDA publication 

found that nanoscale titanium dioxide included in a formulation similar 

to currently marketed sunscreens is unlikely to significantly penetrate 

human skin.46

 

45NIOSH, Current Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide, 

Department of Health and Human Services (NIOSH) Publication No. 2011–160 

(April 2011). 

46N. Sadrieh, A.M. Wokovich, N.V. Gopee, J. Zheng, D. Haines, D. Parmiter, P.H. 

Siitonen, C.R. Cozart, A.K. Patri, S.E. McNeil, P.C. Howard, W.H. Doub, L.F. Buhse, 

“Lack of Significant Dermal Penetration of Titanium Dioxide from Sunscreen Formulations 

Containing Nano- and Sub-Micron-Size TiO2 Particles,” Toxicological Sciences, vol. 115, 

no. 1 (2010):156-66.
 

Page 28 GAO-12-427 Nanotechnology

Figure 5: Nanomaterials Studied by Seven NNI Member Agencies’ EHS Research Projects, Fiscal Year 2010

Notes: The figure is based upon our analysis of the 193 projects we determined were primarily 

directed at EHS. It does not include the 43 projects for which it was not clear to us that the research 

was primarily directed at EHS, nor those not targeted to particular nanomaterials. The numbers of 

projects shown do not total 193 because projects often targeted more than one nanomaterial. 

a

Of the 52 projects that targeted titanium oxides, at least 48 projects studied titanium dioxide. Two 

projects studied titanium oxides, but it was not clear if these included titanium dioxide. 

b

Other metal-based nanomaterials consisted of various metals, such as cobalt, copper, magnesium, 

manganese, nickel, and others, as well as some composites of multiple metals. 

c

Other carbon-based nanomaterials consisted of carbon nanofibers, carbon nanowires, carbon 

nanohorns, carbon black, diamond, graphene, nanoscale graphene platelets, plastic composite 

material containing carbon nanofibers, and soot nanoparticle agglomerates. 

d

Other polymers consisted of polystyrene, polyhedral oligomeric silsesquioxanes, nylon 6 nanofibers, 

plastics, polymeric nanovesicles, and poly(propargyl glycolid) nanoparticles. 

e

Other organic-based nanomaterials consisted of flourescein, sucrose, and dioctyl phthalate particles. 

f

Other semiconductor-based nanomaterials consisted of selenium nanoparticles and cadmium and 

lead selenides/sulfides. 
 

Page 29 GAO-12-427 Nanotechnology

NNI has not prioritized nanomaterials for EHS research, but the 2011 NNI 

EHS research strategy outlines criteria to assist its member agencies in 

doing so. The main criteria NNI proposed are the extent to which (1) 

study of a particular nanomaterial may provide a major contribution to the 

research knowledge base, and (2) nanomaterials and nanotechnologyenabled products may pose a safety concern to workers, consumers, and 

the environment. NNI further identified five criteria for assessing whether 

a material may pose a safety concern: (1) the nanomaterial’s potential for 

hazard, (2) likelihood of exposure, (3) high reactivity, (4) biological 

novelty, and (5) the involvement of the material in an event that produced 

health or environmental impacts. However, because the criteria were 

published in October 2011, it is too soon to tell how they will influence 

NNI member agencies’ decisions about which nanomaterials to prioritize.

Furthermore, it is unclear if the information needed to use the NNI criteria 

is available. As we reported in May 2010, predicting and assessing the 

potential hazards, exposures, and resulting risks from nanomaterials is 

difficult, and current understanding of nanomaterial toxicity and exposure 

is limited. For example, the findings from completed toxicity studies of a 

nanomaterial constructed in one manner may not be applicable to 

understanding the risks posed by the same nanomaterial constructed in a 

different manner and, therefore, studies of similar nanomaterials may not 

be comparable.47 Also, according to the NRC’s 2012 draft strategy for 

nanotechnology EHS research, there is incomplete information on the 

effects of the array of nanomaterials used in products and a lack of 

information on effects of chronic exposures. NRC reported that most 

toxicity studies test a single material and usually focus on effects of acute 

exposures.48

In addition, reliable, comprehensive information is not readily available on 

the likelihood of exposure to nanomaterials. Consumers and workers are 

more likely to be exposed to nanomaterials that are already produced in 

large quantities or incorporated into a larger number of products, but 

information on the prevalence or production volumes of nanomaterials or 

nanotechnology-enabled products is currently limited. As previously noted 

in this report, FDA, CPSC, and EPA may not receive complete 

 

47GAO-10-549. 

48NRC, A Research Strategy for Environmental, Health, and Safety Aspects of 

Engineered Nanomaterials (2012).

Effect of Recent NNI 

Criteria for Agencies’ 

Prioritization of 

Nanomaterials Is Not Yet 

Clear
 

Page 30 GAO-12-427 Nanotechnology

information on what nanomaterials are already in use in the case of 

certain products. CPSC officials told us that one way the agency collects 

information on the use of nanomaterials in products to better understand 

potential exposures is by purchasing information from commercial 

vendors. However, we found that obtaining such information from 

commercial vendors such as market research companies can be costly, 

and it is difficult to assess the reliability of such research because it can 

involve data and methods, including modeling based on various 

assumptions, that may be proprietary.

Another source of information on nanomaterials in commerce is the 

Woodrow Wilson International Center for Scholars’ Project on Emerging 

Nanotechnologies, which maintains an inventory of nanotechnologybased products.49 As of the March 2011 update to the list, the inventory 

contained approximately 1,300 nanotechnology-based products. 

However, the Wilson Center’s list is not comprehensive, and it consists of 

consumer products.50 As we reported in May 2010, occupational 

exposure is a particular concern because the exposure and risk to 

workers is potentially greater than the risk to consumers.51 At present, 

though, there is little information on the exposure of workers to 

nanomaterials in the workplace.

 

49The Wilson Center is a nonpartisan research institution established by an act of 

Congress in 1968 and supported by public and private funds. The Project on Emerging 

Nanotechnologies was established in April 2005 as a partnership between the Wilson 

Center and the Pew Charitable Trusts. The project’s mission is to, among other things, 

collaborate with researchers, government, industry, and others to identify gaps in 

knowledge and regulatory processes, develop strategies for closing them, and provide 

independent, objective knowledge and analysis related to the development and 

commercialization of nanotechnologies.

50According to the Wilson Center, the inventory is based on information that can be readily 

found on the Internet about products that (1) can be readily purchased by consumers and 

(2) are identified as nanotechnology-based by the manufacturer or another source. The 

center tried to avoid including products that clearly do not use nanotechnology, but they 

did not verify manufacturers’ claims or conduct any independent testing of products.

51GAO-10-549. 
 

Page 31 GAO-12-427 Nanotechnology

The NNI member agencies have collaborated extensively with each other 

and nonfederal stakeholders on EHS research and strategies. The NNI 

member agencies participated in interagency efforts to develop joint 

strategies related to EHS research. They have also undertaken over 40 

collaborative nanotechnology EHS research projects in recent years, 

signing agreements with both federal and nonfederal stakeholders. Many 

of the nonfederal stakeholders responding to our questionnaire rated their 

collaborative activities with NNI agencies as very or generally useful, 

although they have identified some challenges.

NNI member agencies have collaborated through the NSTC to develop 

joint EHS research strategies. The NSTC primarily coordinates 

nanotechnology EHS research through the NSET Subcommittee and the 

NEHI, an interagency working group. The NEHI’s purpose includes 

providing for an exchange of information among agencies and with 

nonfederal stakeholders; facilitating the identification, prioritization, and 

implementation of nanotechnology EHS research; and managing the EHS 

interagency research strategy and facilitating its implementation. The 

2011 NNI EHS research strategy was developed by NNI member 

agencies working through the NEHI working group. The strategy sets a 

common vision for nanotechnology EHS research, EHS research 

categories and needs, and key principles intended to assist the NNI 

member agencies make strategic decisions about research programs that 

will advance the NNI EHS research agenda while meeting their respective 

missions. According to several NNI member agency officials, individual 

agencies’ implementation efforts of the 2011 NNI EHS research strategy 

are discussed at NEHI meetings. However, since the strategy was 

finalized in October 2011, it is too soon to tell to what extent it will be used 

to integrate the NNI member agencies’ implementation plans. The 2011 

NNI EHS research strategy updated and replaced the 2008 NNI Strategy 

for Nanotechnology-Related EHS Research, which had established 

common priority EHS research needs. The 2008 NNI Strategy for 

Nanotechnology-Related EHS Research was also developed by the NEHI 

working group and informed by earlier publications of NNI EHS research 

needs.

Officials from five of the NNI member agencies told us that they use the 

NEHI working group as a forum to collaborate on nanotechnology EHS 

research projects. For example, CPSC officials told us that they identify 

agencies with expertise on testing nanomaterials found in consumer 

products through discussions in the NSET Subcommittee and NEHI 

working group, which has led to collaborative testing of exposure and 

NNI Member 

Agencies Have 

Collaborated 

Extensively on 

Nanotechnology EHS 

Research

NNI Member Agencies 

Have Collaborated to 

Develop Joint Strategies
 

Page 32 GAO-12-427 Nanotechnology

release of selected nanomaterials. This collaboration has resulted in data 

that support the respective missions of the collaborative agencies. 

Officials from the National Toxicology Program at NIH noted that they 

selected nanomaterials for study based in part on discussions in the NEHI 

working group and NNI sponsored workshops. Officials from NIST told us 

that NNI member agencies are also working through the NEHI working 

group to develop an inventory of collaborative EHS research activities. 

Collaborative activities related to EHS research have been reported in the 

2011 NNI EHS research strategy and annual NNI Supplements to the 

President’s Budget.

The NNI member agencies have recently initiated numerous 

nanotechnology EHS research projects in collaboration with other federal 

agencies and nonfederal stakeholders. We reviewed formal collaborative 

nanotechnology EHS research projects initiated from February 2008 to 

October 2011, while the 2008 NNI Strategy for Nanotechnology-Related 

EHS Research was in effect. The 2008 NNI Strategy for NanotechnologyRelated EHS Research called for the NEHI and the NNI member 

agencies to coordinate agency efforts to address priority research needs 

and, among others, identify opportunities for collaboration and joint 

development and use of resources where appropriate, facilitate 

partnerships with industry, and coordinate and support international 

efforts, support development of consensus-based standards, and 

facilitate wide dissemination of research results and other nonproprietary 

EHS information. During this period, NNI member agencies initiated 43 

formal collaborative projects related to EHS research––24 interagency 

collaborations and 19 collaborations that included nonfederal 

stakeholders. Most of the interagency collaborations were among the NNI 

member agencies included in our review, but a few were with other 

federal agencies such as the Department of Defense, the Department of 

Labor’s Occupational Safety and Health Administration, and the 

Department of Agriculture. Nonfederal stakeholders included foreign 

governments, such as the United Kingdom (UK) and China; universities, 

such as the University of Massachusetts, Lowell and Rice University; and 

NGOs, such as the International Alliance for NanoEHS Harmonization 

NNI Member Agencies 

Have Engaged In 

Numerous Collaborative 

EHS Research Projects
 

Page 33 GAO-12-427 Nanotechnology

(IANH) and the International Life Sciences Institute Research 

Foundation.52

NNI member agencies used these collaborative projects to extend their 

capability to achieve their individual missions. For example, CPSC 

collaborated with four agencies to conduct research on nanomaterials 

found in consumer products. NIOSH, an agency within the Centers for 

Disease Control and Prevention that conducts research and makes 

recommendations for the prevention of work-related injury and illness, 

partnered with entities that operate nanomanufacturing facilities to better 

understand the potential for occupational exposure to nanomaterials. 

NIST, which aims to advance measurement science, standards, and 

technology, signed an agreement with the IANH to jointly create protocols 

for toxicological tests of selected representative nanoparticles, confirming 

inter-laboratory reproducibility and verifying the predictability of certain 

procedures.

Collaborative EHS research projects have resulted in transfers of funding 

as well as sharing of expertise, facilities, and other resources, as shown 

in the following examples:

• An interagency agreement between CPSC and NIOSH to study the 

pulmonary effects of titanium dioxide nanoparticles released from 

aerosol spray products involved CPSC providing the product to be 

tested and transferring funding to NIOSH to construct the testing 

equipment, with NIOSH providing expertise and staff time to run the 

tests and produce a report.

• An agreement among the NIH’s National Cancer Institute, the 

National Institute of Environmental Health Sciences (NIEHS), and the 

National Institute of Biomedical Imaging and Bioengineering to 

develop, maintain, and operate a web-based nanomaterial registry 

specified that the National Institute of Biomedical Imaging and 

Bioengineering will develop the registry to provide consistent and 

curated information on the biological and environmental interactions of 

 

52The IANH is a group of internationally recognized experts who have agreed to develop 

specific tools and testing protocols and perform a set of round robin experiments for 

reproducible testing of nanomaterial biological interactions and toxicology. The 

International Life Sciences Institute Research Foundation is a nonprofit organization 

based in Washington, D.C., that focuses on advancing the methods and application of 

science in risk assessment, human nutrition, and the prevention of obesity.
 

Page 34 GAO-12-427 Nanotechnology

well-characterized nanomaterials, as well as links to associated 

publications, modeling tools, computational results, and 

manufacturing guidance from existing databases. The National 

Cancer Institute and the NIEHS provided funding. NIEHS also 

committed to provide input to the constitution of an advisory board 

and attend its meetings, as well as be represented in the nano registry 

project management team.

• Agencies have also issued joint solicitations for grant applications, 

such as one between EPA and a number of UK agencies to solicit 

proposals for research on environmental and health implications of 

nanotechnology. EPA and the UK agencies signed an agreement that 

notes (1) the funding of grants will be made consistent with the budget 

priorities of each party and (2) they are to work jointly to define the 

scientific priorities, issue the request, assist with peer review and 

selection of grantees, and disseminate the research results.

Details on these and other collaborative EHS research projects are 

provided in appendix II.

The 138 nonfederal stakeholders who responded to our questionnaire 

reported that they benefited from collaboration with NNI member 

agencies but faced some challenges. Most respondents indicated that the 

2011 NNI EHS research strategy was very or somewhat effective at 

addressing the EHS research needs. Respondents reported that they 

also obtained information on nanotechnology EHS risks from NNI 

member agencies and nongovernmental sources.

The following three formal mechanisms for collaboration with NNI 

member agencies were most frequently identified by respondents as 

generally or very useful to them: (1) joint data gathering and sharing; (2) 

joint research solicitations or funding of research consortia; and (3) 

competitive grants. See figure 6 for respondents’ ratings of seven formal 

collaborative mechanisms we identified for them to rate. Some 

respondents who provided comments in response to optional open-ended 

questions also identified public-private partnerships, such as joint 

academic, government, and industry information exchange and research 

programs, as collaboration mechanisms the NNI member agencies 

should consider. A few respondents who commented in response to 

optional open-ended questions also cited benefits to informal 

collaboration with NNI agencies, such as discussions during workshops 

and conferences.

Nonfederal Stakeholders 

We Surveyed Benefited 

from NNI Collaboration 

but Identified Some 

Challenges

Many of the Respondents to 

Our Questionnaire Rated 

Collaboration with NNI 

Member Agencies on EHS 

Research as Generally or Very 

Useful
 

Page 35 GAO-12-427 Nanotechnology

Figure 6: Usefulness of Formal Collaboration Mechanisms for Nanotechnology EHS Research, According to Questionnaire 

Respondents

Note: Excludes respondents who selected “No basis to judge” and those who did not check a 

response. 

Since both the 2011 NNI EHS research strategy and its predecessor, the 

2008 NNI Strategy for Nanotechnology-Related EHS Research, called for 

partnerships with industry and other nonfederal stakeholders, we included 

questions about collaboration with NNI member agencies in our 

questionnaire. When asked about the usefulness of their collaboration 

with the NNI member agencies, more than half of respondents rated their 

collaborative EHS research or related activities for each of the NNI 

member agencies as generally or very useful, as seen in figure 7.
 

Page 36 GAO-12-427 Nanotechnology

Figure 7: Usefulness of Collaborative EHS Research or Related Activities with NNI 

Member Agencies, According to Questionnaire Respondents

Note: Excludes respondents who selected “No basis to judge” and those who did not check a 

response. 

Stakeholders responding to our questionnaire indicated that certain 

challenges to collaboration with NNI member agencies we identified on 

EHS research apply to them. As seen in figure 8, more than two-thirds of 

those who rated the challenge of lack of funding and the challenge of 

limited awareness of collaboration opportunities indicated that each of 

these challenges apply to them. This is consistent with what we heard 

from representatives of a nanotechnology trade association and an NGO, 

who stated that there is limited funding for corporate EHS research and 

development efforts because they do not generate revenues. Some 

respondents who provided comments in response to optional open-ended 

questions stated that the private sector needs government funding for 

EHS research. A number of respondents also commented that 

government funding for EHS research was inadequate or an “afterthought” to other purposes. Some respondents also commented that 

funding seems to be targeted toward large, multiyear centers rather than 

smaller targeted projects that can help address near-term EHS needs.

Respondents to Our 

Questionnaire Indicated a 

Number of Challenges to 

Collaboration with NNI 

Member Agencies Apply to 

Them
 

Page 37 GAO-12-427 Nanotechnology

More than half of those responding noted that each of the challenges of 

regulatory uncertainty, lack of standardization—such as different 

terminology or protocols—and concerns regarding disclosure of 

proprietary or confidential business information, apply to them. Some 

respondents cited regulatory uncertainty—that is, lack of a clear 

regulatory environment to enable commercialization and protect 

consumers and the general public—as a challenge to collaboration with 

their work with NNI member agencies on nanotechnology EHS research. 

For example, a number of respondents who provided comments in 

response to optional open-ended questions pointed to regulatory 

uncertainty as limiting the ability of companies to determine their EHS 

responsibilities. Some respondents also commented on difficulties in 

collaborating with NNI member agencies resulting from differences in 

expertise and regulatory approaches across different government 

agencies or even within the same agency. With regard to lack of 

standardization as a challenge to collaboration on nanotechnology EHS 

research, some respondents provided examples related to the lack of 

scientific consensus on the definition of nanomaterials, the testing 

methods for toxicology research, and common terminology across 

research and regulatory agencies.
 

Page 38 GAO-12-427 Nanotechnology

Figure 8: Challenges to Collaboration on Nanotechnology EHS Research, 

According to Questionnaire Respondents

Note: Excludes respondents who selected “Don’t know/Not sure” and those who did not check a 

response. 

When asked to rate the effectiveness of mechanisms we identified that 

NNI member agencies can use for obtaining input from nonfederal 

stakeholders on the development of the NNI EHS research strategies, 

respondents most frequently identified the following three mechanisms as 

being used somewhat effectively or effectively: (1) workshops, 

conferences, and other public speaking engagements; (2) advisory 

councils; and (3) the NNI web portal.

Most Respondents to Our 

Questionnaire Rated the 2011 

NNI EHS Research Strategy as 

Somewhat or Very Effective
 

Page 39 GAO-12-427 Nanotechnology

Figure 9: Effectiveness of Mechanisms for Obtaining Input on the NNI Strategic Planning for EHS Research, According to 

Questionnaire Respondents

Note: Excludes respondents who selected “No basis to judge” and those who did not check a 

response. 

When asked to rate the 2011 NNI EHS research strategy, most of those 

responding rated this strategy as somewhat or very effective at 

addressing nanotechnology EHS research needs. As seen in figure 10, 

while just over half of those responding to these questions indicated the 

2008 NNI Strategy for Nanotechnology-Related EHS Research 

addressed these needs somewhat or very effectively, 79 out of 98 

indicated the 2011 NNI EHS research strategy addressed these needs 

somewhat or very effectively.53

 

53The NSTC finalized the 2011 NNI EHS research strategy while the questionnaire was 

being completed by respondents. Therefore, some respondents may have rated the draft 

2011 NNI EHS research strategy while others may have rated the final version. 

Some of the respondents who commented 

in response to optional open-ended questions commended the 2011 NNI 

EHS research strategy for accurately capturing the input of the 

workshops’ participants and summarizing the research needs, but others 

pointed to shortcomings, including a lack of prioritization and insufficient 

focus on implementation. For example, one respondent commented that 

the strategy would only be effective if it was implemented, and that it may 

not be sufficient to rely on the agencies’ voluntary implementation efforts.
 

Page 40 GAO-12-427 Nanotechnology

Figure 10: Effectiveness of NNI EHS Research Strategies at Addressing Nanotechnology EHS Research Needs, According to 

Questionnaire Respondents

Note: Excludes respondents who selected “No basis to judge” and those who did not check a 

response. 

Additionally, respondents identified various sources, including the NNI 

member agencies, from which they obtained information on the potential 

EHS risks of nanotechnology. When asked to estimate the frequency with 

which they obtained nanotechnology EHS information from NNI member 

agencies in recent years, respondents reported obtaining information 

from the NNI member agencies in varying frequencies. More than half of 

the respondents to these questions reported occasionally or often 

obtaining information from EPA and NIOSH, as seen in figure 11.

Respondents Obtained 

Nanotechnology EHS 

Information from Various 

Sources 
 

Page 41 GAO-12-427 Nanotechnology

Figure 11: Frequency with Which Questionnaire Respondents Reported Obtaining 

Information on the Potential EHS Risks of Nanotechnology from NNI Member 

Agencies

Note: Excludes respondents who selected “Don’t know/Not sure” and those who did not check a 

response. 

The 2011 NNI strategic plan calls for providing a “one-stop” Internetbased portal for nanotechnology information, including, among other 

things, scientific data such as characterization and toxicity 

measurements. About 80 percent of the 131 stakeholders responding to a 

question about how useful such a portal would be indicated that an 

Internet-based portal for nanotechnology EHS information would be 

generally or very useful to them. The NNI does not currently provide a 

portal that contains this information, but an NNCO official told us that the 

NNCO is implementing a web-based map that identifies the 

instrumentation and facilities for nanotechnology research at major 

universities and centers in the U.S. and federal labs.

When asked to rate the frequency with which they obtained information 

on the potential EHS risks of nanotechnology from nongovernmental 

sources, as seen in figure 12, more than two-thirds of respondents 

reported that they occasionally or often obtained information from each of 

the following four sources: (1) peer-reviewed scientific publications; (2) inhouse research; (3) online databases; and (4) news outlets.
 

Page 42 GAO-12-427 Nanotechnology

Figure 12: Frequency with Which Questionnaire Respondents Reported Obtaining Information on the Potential EHS Risks of 

Nanotechnology from Nongovernmental Sources

Note: Excludes respondents who selected “Don’t know/Not sure” and those who did not check a 

response. 
 

Page 43 GAO-12-427 Nanotechnology

NNI strategy documents address two and partially address four of the six 

desirable characteristics of effective national strategies that we identified 

in prior work and that offer policymakers and implementing agencies a 

management tool that can help ensure accountability and more effective 

results. The three NNI strategy documents––the 2011 NNI strategic plan, 

the 2011 NNI EHS research strategy, and the NNI Supplement to the 

President’s 2012 Budget54

We rated the NNI strategy documents to determine how well they jointly 

addressed the six characteristics that we have identified for effective 

national strategies, as described in table 3.

––compose a national strategy for 

nanotechnology EHS research and create a framework for achieving NNI 

program goals and priorities.

Table 3: Summary of Desirable Characteristics for a National Strategy

Desirable characteristic Brief description

Purpose, scope, and 

methodology 

Addresses why the strategy was produced, the scope 

of its coverage, and the process by which it was 

developed. 

Problem definition and risk 

assessment 

Addresses the particular national problems and 

threats the strategy is directed toward. 

Goals, subordinate objectives, 

activities, and performance 

measures 

Addresses what the strategy is trying to achieve; 

steps to achieve those results; as well as the 

priorities, milestones, and performance measures to 

gauge results. 

Resources, investments, and 

risk management 

Addresses what the strategy will cost, the sources 

and types of resources and investments needed, and 

where resources and investments should be targeted 

by balancing risk reductions and costs. 

Organizational roles, 

responsibilities, and 

coordination 

Addresses who will be implementing the strategy, 

what their roles will be compared to others, and 

mechanisms for them to coordinate their efforts. 

Integration and implementation Addresses how a national strategy relates to other 

strategies’ goals, objectives, and activities—and to 

subordinate levels of government and their plans to 

implement the strategy. 

Source: GAO-04-408T. 

 

54NSTC, Committee on Technology, Subcommittee on Nanoscale Science, Engineering, 

and Technology, National Nanotechnology Initiative Environmental, Health, and Safety 

Research Strategy (October 2011); National Nanotechnology Initiative Strategic Plan

(February 2011); and The National Nanotechnology Initiative Supplement to the 

President’s 2012 Budget (February 2011).

NNI Strategy 

Documents Address 

or Partially Address 

Desirable 

Characteristics of 

National Strategies
 

Page 44 GAO-12-427 Nanotechnology

Ideally, effective national strategies should fully address all of these 

characteristics. However, we recognize that by their nature, national 

strategies are intended to provide broad direction and guidance—rather 

than be prescriptive, detailed mandates—to the relevant implementing 

agencies. Thus it is unrealistic to expect all national strategies to provide 

details on each and every characteristic we identified. Moreover, the NNI 

member agencies have different statutory authority and functions that 

may significantly affect their research and research priorities. 

Nonetheless, we believe the more detail a strategy provides, the easier it 

is for the responsible parties to implement it and achieve its goals.

We reviewed the three NNI strategy documents for elements related to 

these characteristics, and based on the inclusion of these elements, rated 

how well the strategic documents address the six characteristics. 

According to our methodology, the strategy documents “address” a 

characteristic when they explicitly include all, or nearly all, elements of the 

characteristic and have sufficient specificity and detail. The documents 

“partially address” a characteristic when they include some or most of the 

elements of the characteristic with sufficient specificity and detail.55

As described in table 4, we found, when reviewed as a whole, that the 

strategy documents address or partially address all of the desirable 

characteristics of a national strategy.

The 

documents “do not address” a characteristic when they do not include any 

elements of a characteristic or references are too vague or general to be 

useful. Additional details about our ratings and the elements that make up 

these characteristics are available in appendix I.

 

55The “partially addresses” category includes a range that varies from explicitly citing most 

of the elements to citing as few as one of the elements of a characteristic. Yet because 

the three NNI documents have different purposes and audiences an individual document 

need not address each desirable national strategy characteristic. However, areas not 

addressed in one document should be more fully developed in another. 
 

Page 45 GAO-12-427 Nanotechnology

Table 4: Extent NNI Strategy Documents Address GAO’s Desirable Characteristics 

with Respect to Nanotechnology EHS Research

Desirable characteristic Address

Partially 

address Do not address

1) Purpose, scope, and methodology X 

2) Problem definition and risk 

assessment 

X 

3) Goals, subordinate objectives, 

activities, and performance 

measures

X 

4) Resources, investments, and risk 

management

X 

5) Organizational roles, responsibilities, 

and coordination

X 

6) Integration and implementation X 

Source: GAO analysis of the NNI strategy documents.

Taken as a whole, the NNI strategy documents address the first two 

characteristics—purpose, scope, and methodology and problem definition 

and risk assessment—by including all, or nearly all, of their elements. 

These characteristics describe the scope of the strategy, describe how 

and why it was produced, define the problems the strategy intends to 

address, discuss causes and the operating environment, and provide a 

risk assessment or broad description of potential risks. Elements of these 

characteristics that are included in the documents are providing a clear 

statement of purpose, defining key terms, delineating what major 

functions or mission areas are covered, discussing problems with the 

current understanding of EHS implications of nanotechnology, and the 

quality of currently available data, among others.

The NNI strategy documents partially address the third characteristic 

regarding goals, subordinate objectives, activities, and performance 

measures. This characteristic describes the overall desired results, 

hierarchy of strategic goals and subordinate objectives, priorities, 

milestones, outcome-related performance measures, and process for 

monitoring and reporting on progress, among others. The NNI strategy 

documents include a number of elements such as desired results, 

strategic goals, and subordinate objectives, but do not include, or do not 

fully develop, other elements such as priorities, milestones, or outcomerelated performance measures. Performance information—such as 

outcome-related performance measures and milestones comprised of 

targets and time frames for meeting those measures—allows managers 

Purpose, Scope, and 

Methodology and Problem 

Definition and Risk Assessment 

(Desirable Characteristics 

1 and 2) 

Goals, Subordinate Objectives, 

Activities, and Performance 

Measures (Desirable 

Characteristic 3) 
 

Page 46 GAO-12-427 Nanotechnology

to identify performance problems and develop approaches that improve 

results. For the purposes of this report, we define performance 

information to mean data collected to measure progress toward achieving 

an established goal. A wide range of information can be relevant to 

program performance. Performance information can focus on various 

dimensions of performance such as outcomes, outputs, quality, 

timeliness, customer satisfaction, or efficiency. It can inform key 

management decisions such as setting program priorities, allocating 

resources, identifying program problems, and taking corrective action to 

solve those problems; or it can help determine progress in meeting the 

goals of programs or operations. The NNI strategy documents contain 

detailed research needs for nanotechnology EHS and report the annual 

funding of EHS research and the number of projects supported for 

selected years, but the documents do not prioritize among these needs or 

include outcome-related performance measures, targets, or time frames 

that allow for monitoring and reporting on progress toward meeting the 

research needs.

Independent reviews of the prior NNI strategy documents also noted an 

absence of performance information. In 2010, the National 

Nanotechnology Advisory Panel recommended that the NNCO monitor 

metrics that assess, among other things, the NNI’s progress on 

developing methodologies to assess plausible risks of nanotechnology. 

The advisory panel also recommended that the NEHI working group 

develop and implement a strategy that links EHS research activities with 

knowledge gaps and decision-making needs. The 2009 NRC review 

concluded that the 2008 NNI Strategy for Nanotechnology-Related EHS 

Research could be an effective tool, but did not include a number of 

elements, including measures of research progress. We previously 

reported that, ideally, a national strategy would set clear desired results 

and priorities, outcome-related performance measures, and specific 

milestones while giving implementing parties flexibility to pursue and 

achieve those results within a reasonable time frame.56

The NNI strategy documents give agencies wide latitude to develop 

research programs to meet the goals and research needs of the NNI, but 

we found that NNI member agencies vary in their identification and 

reporting of agency-specific performance information for nanotechnology 

 

56GAO-04-408T. 
 

Page 47 GAO-12-427 Nanotechnology

EHS research that could align with the NNI research needs. The 2011 

NNI EHS research strategy states that prioritization, timing, and staging of 

the research needs identified by the strategy are components of an 

implementation plan and should be developed within agency missions 

and appropriations. Similarly, the 2011 NNI strategic plan states that the 

document serves as a guide for individual agency implementation. Six of 

the seven NNI agencies we reviewed have documented performance 

measures, targets, or time frames for their EHS research. Three of the 

NNI member agencies—CPSC, FDA, and NIH—annually report EHSrelated performance information through their publicly available annual 

performance reports.57 Three other NNI member agencies—EPA, NIOSH, 

and NIST—identify strategic goals and performance measures and 

targets in their program-level nanotechnology EHS strategies, but have 

not collected, or have not publically reported results of these performance 

measures.58

The NNI strategy documents partially address the fourth and fifth 

characteristics describing resources, investments, and risk management 

and organizational roles, responsibilities, and coordination. We found that 

the documents include some, but not all, of the elements of these 

characteristics. With respect to the fourth characteristic, we found that the 

documents include elements relating to agency resources associated with 

the strategy such as descriptions of current activities of NNI member 

NIOSH has previously published research summaries in its 

nanotechnology research progress reports. NIOSH officials told us that a 

forthcoming progress report will also document the results of performance 

measures identified in their nanotechnology EHS strategy. NSF reports 

planned EHS research activities as part of its annual budget request, but 

does not identify performance targets or measures for its nanotechnology 

EHS research beyond funding requested. According to an NNCO official, 

the NEHI working group is piloting an effort to gather information from the 

NNI member agencies to assess high-level progress toward meeting NNI 

research needs, but has not released the results of this work.

 

57CPSC, 2010 Performance and Accountability Report (November 2010); Department of 

Health and Human Services, Food and Drug Administration, FY2012 Online Performance 

Appendix; Department of Health and Human Services, National Institutes of Health, 

FY2012 Online Performance Appendix. 

58EPA, Nanomaterial Research Strategy, EPA 620/K-09/011 (June 2009); NIOSH, 

Strategic Plan for NIOSH Nanotechnology Research and Guidance, Department of Health 

and Human Services (NIOSH) Publication No. 2010-105 (November 2009); NIST, 

Nanomaterial Environmental, Health and Safety (Nano-EHS) Program Plan, FY10-FY14. 

Resources, Investments, and 

Risk Management and 

Organizational Roles, 

Responsibilities, and 

Coordination (Desirable 

Characteristics 4 and 5) 
 

Page 48 GAO-12-427 Nanotechnology

agencies and current investment levels. However, we found that the 

documents do not include, or do not fully develop, other elements such as 

the costs and types of resources—for example human capital or research 

and development costs—associated with implementing the strategy. An 

NNCO official told us that the NNI does not analyze the costs of 

resources to meet the EHS research needs because it does not control 

the funding for member agencies, and that each agency allocates funding 

and prioritizes its activities based on its mission area and available 

budget. According to this official, the 2011 NNI EHS research strategy 

identifies research goals, but it is up to the agencies to determine how 

their funding should be spent. Similarly, a NIST official told us that the 

NNI cannot dictate to agencies how or what research to fund. With 

respect to the fifth characteristic pertaining to organizational roles, 

responsibilities, and coordination, we found that the documents include 

elements such as lead, support, and partner roles for agencies and 

processes for coordination and collaboration, but do not include, or do not 

fully develop, other elements such as an accountability and oversight 

framework. The strategy documents include detailed descriptions of the 

NNI structure, describe coordination mechanisms such as the NEHI 

working group, and provide examples of collaborative activities related to 

EHS research. As we reported above, we found that NNI member 

agencies have engaged in numerous collaborative projects with federal 

and nonfederal partners and nonfederal partners generally rated these 

collaborations as generally or very useful. However, the strategy 

documents do not provide details on oversight of agency roles or how 

agencies will be held accountable to the goals and research needs of the 

NNI strategy documents.

The NNI strategy documents also partially address the sixth characteristic 

describing integration and implementation. This characteristic describes 

how the national strategy documents relate to subordinate levels of 

government and their plans to implement the strategy. As we have 

previously reported, to achieve a common outcome, collaborating 

agencies need to establish strategies that work in concert with those of 

their partners or are joint in nature.59

 

59GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain 

Collaboration Among Federal Agencies, 

We found that the NNI strategy 

documents include limited information regarding the elements of this 

characteristic. For example, the 2011 NNI EHS research strategy 

GAO-06-15 (Washington, D.C.: Oct. 21, 2005).

Integration and Implementation 

(Desirable Characteristic 6)
 

Page 49 GAO-12-427 Nanotechnology

describes a framework for implementation, but does not provide detailed 

implementation guidance.60

Five of the seven NNI member agencies we reviewed have developed 

such agency-level nanotechnology EHS research strategies. As noted 

above, EPA, NIOSH, and NIST have developed strategic plans 

specifically for EHS research. In addition, FDA has published a strategic 

plan for its regulatory science research efforts, which include 

nanotechnology, and developed a research plan specifically targeting 

nanotechnology.

In addition, we found that the NNI strategy 

documents generally do not include information on the NNI member 

agencies’ nanotechnology EHS strategies or plans or their integration 

with the national strategy.

61 Furthermore, NSF officials told us that the agency 

describes its strategic direction for nanotechnology, including current and 

proposed activities and funding by PCA, in its annual budget request.62

 

60The 2011 NNI EHS research strategy states that, because individual agency priorities 

may differ in scope and focus from the NNI research needs, the NSTC relies on 

coordination through NEHI to ensure integration of agency plans. 

CPSC includes nanotechnology as an external risk factor for its 

agencywide strategic plan, but the plan does not address EHS research 

directly. NIH officials told us they do not have agency or institute-specific 

strategic plans that specifically address nanotechnology EHS research, 

but nanotechnology EHS research plans developed by its institutes 

conform to the NNI strategy. Of the five agencies with nanotechnology 

EHS-related strategies, two—FDA and NIOSH—explicitly align agency 

research goals in their strategic plans for nanotechnology to NNI EHS 

research needs. The FDA and NIOSH strategic plans describe the 

agencies’ EHS research goals, their framework for meeting those goals, 

and which NNI EHS research needs will be advanced. NIST’s Nano-EHS 

program plan, EPA’s Nanomaterial Research Strategy, and NSF’s budget 

request to Congress describe agency research objectives. The

documents do not explicitly identify NNI research needs; however, 

agency officials told us that they reflect the NNI strategic documents. The 

2011 NNI strategic plan reports that NNI member agencies have initiated 

61FDA, Advancing Regulatory Science at FDA (August 2011), 

http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm, 

and FDA, Nanotechnology Regulatory Science Research Plan, 

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm273325.htm. 

62NSF, NSF FY2012 Budget Request to Congress, 

http://www.nsf.gov/about/budget/fy2012/index.jsp. 
 

Page 50 GAO-12-427 Nanotechnology

a mapping exercise to evaluate how this strategic plan relates to NNI 

member agencies’ strategic plans and to the priorities of the 

administration. In addition, according to NNI member agency officials, 

individual agencies’ implementation efforts of the 2011 NNI EHS research 

strategy are discussed at NEHI meetings. However, the results of this 

mapping exercise and proceedings of the NEHI are not publically 

available.

The increasing commercialization of nanotechnology-enabled products and 

information gaps related to nanotechnology EHS impacts underscore the 

importance of ensuring progress toward meeting EHS strategic goals and 

research needs. The NNI strategy documents help shape the policies, 

programs, priorities, resource allocations, and standards related to 

nanotechnology EHS research and activities. The NNI strategy documents 

address or partially address the desirable characteristics of effective 

national strategies, including overarching strategic goals and objectives 

such as the EHS research needs. However, the documents do not include 

some elements of the characteristics, which could make it more difficult for 

federal agencies and other stakeholders to implement the strategy and 

achieve the identified results. For example, progress toward achieving the 

strategy documents’ goals and research needs cannot be tracked because 

the NNI does not report specific performance information, such as 

performance measures, targets, or time frames. In addition, the NNI 

strategy documents do not include estimates of the costs and types of 

resources associated with these goals and research needs.

Developing and coordinating performance information and cost estimates 

for the NNI’s nanotechnology EHS research may be challenging because 

of the varied missions and priorities of the NNI member agencies. 

However, not having performance information that is aligned with the 

strategic goals and research needs of the NNI makes it difficult for 

agencies, policymakers, and stakeholders to determine the collective 

progress of the national nanotechnology program. Furthermore, 

developing performance information and including it in NNI strategy 

documents could help to strengthen two other desirable characteristics 

that the documents partially address. Specifically, this information could 

also support an accountability and oversight framework—that is currently 

not well-developed—by linking agency activities to specific measures of 

performance and creating consistent benchmarks to judge the overall 

progress of the NNI member agencies. In addition, developing this 

information could facilitate better integration between the NNI strategy 

documents and the NNI member agencies’ nanotechnology EHS 

Conclusion
 

Page 51 GAO-12-427 Nanotechnology

research strategies and goals. Providing cost estimates related to the NNI 

EHS research needs would allow the NNI member agencies, 

policymakers, and stakeholders to assess if investments are 

commensurate with costs of the identified needs. The NSTC, which is 

administered by the OSTP, does not direct funding to meet the NNI 

research needs; however, rough estimates of their costs could serve as 

guidance to the NNI member agencies as they individually determine their 

own budgets and priorities. In addition, the NSTC is well-positioned to 

develop these estimates due to its coordinating role across the member 

agencies of the NNI and corresponding access to expertise at these 

agencies. Developing performance information and cost estimates could 

also support the analysis of the progress made toward achieving the 

goals and priorities established for the program, as required by the 21st 

Century Nanotechnology Research and Development Act.

In addition, we are reiterating our 2008 recommendation that the Director 

of OSTP, in consultation with the Directors of the NNCO and OMB, 

provide better guidance to agencies on how to report their 

nanotechnology EHS research.63 The continued absence of detailed 

guidance on how to report research under PCA 7 has contributed to the 

data reporting problems we identified. Therefore, agencies, policymakers, 

and stakeholders do not have access to accurate, consistent, and 

complete data on the federal government’s investment in nanotechnology 

EHS research. Without reliable and up-to-date data, it will be difficult for 

agencies to accurately assess and report their progress toward their own 

performance measures, as well as the EHS research goals and needs 

identified in the 2011 NNI EHS research strategy.

To better offer policymakers and implementing agencies a management 

tool that can help ensure accountability and more effective results, we are 

making two recommendations to the Director of OSTP:

We recommend that the Director of OSTP coordinate development by the 

NNI member agencies of performance measures, targets, and time 

frames for nanotechnology EHS research that align with the research 

needs of the NNI, consistent with the agencies’ respective statutory 

authorities, and include this information in publicly available reports.

 

63GAO-08-402. 

Recommendations for 

Executive Action
 

Page 52 GAO-12-427 Nanotechnology

We also recommend that, to the extent possible, the Director of OSTP 

coordinate the development by the NNI member agencies of estimates of 

the costs and types of resources necessary to meet the EHS research 

needs.

We provided a draft of this report to the Director, OSTP; Secretary, 

Commerce; Chairman, CPSC; Administrator, EPA; Secretary, Health and 

Human Services; and Director, NSF. OSTP and the agencies neither 

agreed nor disagreed with the recommendations. OSTP and Health and 

Human Services provided technical and clarifying comments, which we 

incorporated as appropriate. The Department of Commerce, CPSC, EPA, 

and NSF indicated they had no comments on the report.

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Director, OSTP; 

Secretary, Commerce; Chairman, CPSC; Administrator, EPA; Secretary, 

Health and Human Services; Director, NSF; and other interested parties.

The report also will be available at no charge on the GAO website at 

http://www.gao.gov. 

If you or your staff have any questions about this report, please contact 

me at (202) 512-3841 or ruscof@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made major contributions to this report 

are listed in appendix III. 

Sincerely yours,

Frank Rusco

Director, Natural Resources 

and Environment

Agency Comments 

and Our Evaluation
Appendix I: Objectives, Scope, and 

Methodology

Page 53 GAO-12-427 Nanotechnology

Our review examines (1) changes in federal funding for nanotechnology 

environmental, health, and safety (EHS) research from fiscal years 2006 

to 2010; (2) the nanomaterials that National Nanotechnology Initiative 

(NNI) member agencies focused on in their EHS research in fiscal year 

2010; (3) the extent to which NNI member agencies collaborate with 

stakeholders on nanotechnology EHS research and related strategies; 

and (4) the extent to which NNI strategy documents address desirable 

characteristics of national strategies.

To conduct this work, we reviewed EHS research efforts funded by seven 

NNI member agencies, which collectively funded 93 percent of EHS 

research dollars in fiscal year 2010: the National Science Foundation 

(NSF), National Institutes of Health (NIH), Environmental Protection 

Agency (EPA), National Institute for Occupational Safety and Health 

(NIOSH), Food and Drug Administration (FDA), National Institute of 

Standards and Technology (NIST), and the Consumer Product Safety 

Commission (CPSC). The first six of these agencies represent the top six 

providers of EHS research funding from fiscal year 2006 to fiscal year 

2010, and CPSC has an important role in ensuring the safe use of 

nanotechnology in consumer products.

To examine recent changes in federal funding for nanotechnology EHS 

research, we reviewed information published by the National Science and 

Technology Council (NSTC) in the NNI Supplements to the President’s 

Budget. Specifically, we reviewed the actual agency investments reported 

in each program component area for fiscal years 2006 through 2010 for 

all NNI member agencies funding nanotechnology research.1

 

1

See NSTC, Committee on Technology, Subcommittee on Nanoscale Science, 

Engineering, and Technology, The National Nanotechnology Initiative Supplement to the 

President’s 2012 Budget (February 2011); The National Nanotechnology Initiative 

Supplement to the President’s 2011 Budget (February 2010); The National 

Nanotechnology Initiative Supplement to the President’s 2010 Budget (May 2009); The 

National Nanotechnology Initiative Supplement to the President’s 2009 Budget 

(September 2008); and The National Nanotechnology Initiative Supplement to the 

President’s 2008 Budget (July 2007).

For the 

dollar amounts that we adjusted for inflation, we used the Biomedical 

Research and Development Price Index to report funding in constant 

2010 dollars. We consulted with the Office of Management and Budget 

(OMB) and officials at the seven selected agencies to determine the type 

of budget information reported as actual agency investments in these

documents. For fiscal year 2010, the most recent year for which actual 

Appendix I: Objectives, Scope, and 

Methodology 
Appendix I: Objectives, Scope, and 

Methodology

Page 54 GAO-12-427 Nanotechnology

agency investment data were available, we also collected quantitative 

and qualitative project-level data (such as project funding amounts and 

project abstracts or progress reports) on all research projects that the 

seven selected agencies had categorized as Program Component Area 

(PCA) 7 (EHS research). The agencies do not report project-level data to 

OMB annually but report their total EHS research funding to OMB 

annually for inclusion in the NNI budget supplements published by NSTC. 

Therefore, we reviewed data on the individual projects included in the 

agencies’ total EHS research funding in 2010. We provided the agencies 

with a spreadsheet template to use in listing their projects, which we 

based on the spreadsheet OMB had used in its data calls to collect 

project-level data from agencies on their 2006 and 2009 EHS research 

projects. Consistent with the approach used in OMB’s data calls, we did 

not ask the agencies to use a standardized definition of what constitutes a 

“project;” instead, we deferred to each agency to identify their projects 

and consulted with agency officials as needed.

For some projects at NIH, NIOSH, and NIST, we grouped together some 

of the agencies’ data entries and counted them together for the purposes 

of our analyses. Consequently, the numbers of projects we are reporting 

may not match the number reported by these agencies elsewhere. 

Specifically, for NIH, we grouped the 14 supplement grants together with 

their main grants and counted each of those groups as a single project. 

We also grouped together the individual subprojects of each of NIH’s 

multiproject “parent” grants reported as EHS and counted each of those 

groups as a single project, for a total of seven groups of multiproject 

grants. In addition, we grouped together two grants made by different NIH 

institutes for the same project. For NIOSH, we identified two project 

entries with identical project descriptions. After consulting with NIOSH 

officials, we grouped those two entries together and counted them as a 

single project. For NIST, the agency reported a separate entry for each of 

its Project Tracking Numbers and explained that a single technical project 

is often associated with more than one Project Tracking Number. NIST 

officials instructed us to group together the entries with identical titles and 

count each of those groups as a single project.

To assess the reliability of the agencies’ fiscal year 2010 data, we sent 

each of the seven selected agencies a set of questions regarding the data 

and the information systems used to produce and store them. We also 

reviewed related supporting documentation, such as user manuals and 

data dictionaries for information systems, and, for some projects, copies 

of the associated interagency agreements. We examined the data for 

obvious errors, compared each agency’s total fiscal year 2010 PCA 7 
Appendix I: Objectives, Scope, and 

Methodology

Page 55 GAO-12-427 Nanotechnology

funding reported to us to the totals reported in the NNI Supplement to the 

President’s 2012 Budget, and consulted with agency officials to 

understand the reasons for any differences. We determined that the data 

were sufficiently reliable for the purposes of our analyses. However, we 

did not attempt to verify the funding amounts reported for each project—

for example, by reviewing documentation of agencies’ actual 

expenditures for each project.

We reviewed the qualitative project data, including abstracts and project 

reports, to assess whether the agencies had appropriately categorized 

the research projects they reported as EHS research—that is, whether 

the projects met the definition of program component area (PCA) 7. As 

described in this report, the definition of PCA 7—research primarily 

directed at understanding the EHS impacts of nanotechnology 

development and corresponding risk assessment, risk management, and 

methods for risk mitigation—is the only written guidance available to 

agencies on how to report their nanotechnology research in this program 

component area. Determining whether research meets this definition is an 

inherently subjective process. Therefore, rather than definitively conclude 

that any projects did not meet the definition, we assigned projects a 

designation of “not clearly PCA 7” if we were ultimately unable to identify 

any EHS research, or it was not clear that EHS was the primary focus of 

the research. For example, some projects studied various 

nanotechnology-enabled drugs, but it was not clear to what extent the 

research was directed at the safety of the drugs versus their efficacy. 

Some other projects appeared to be closely related to program 

component areas other than PCA 7, such as PCA 4 (instrumentation 

research, metrology, and standards for nanotechnology) or PCA 8 

(education and societal dimensions), and it was not clear that PCA 7 was 

the most appropriate category. To minimize bias and to ensure the 

consistency of our evaluation, two analysts independently analyzed the 

project data and used their professional judgment to assess whether each 

project met the PCA 7 definition. The two analysts discussed those 

projects where they did not agree on whether the research was primarily 

directed at EHS and reached agreement. For categorization of projects 

that appeared questionable to us, we generally asked agencies to explain 

why they had reported those projects as EHS research. We reviewed 

agencies’ responses and modified our determinations for projects as 

appropriate given the additional support provided by the agencies. For 

two projects funded by NIST and 18 by NSF, the agencies had reported 

only a portion of the total project funding under PCA 7. In those instances, 

we assessed whether at least some of the project was primarily directed 

at EHS. However, we did not verify that the funding amounts reported as 
Appendix I: Objectives, Scope, and 

Methodology

Page 56 GAO-12-427 Nanotechnology

EHS research were correct because that information is, according to 

these agencies’ officials, based on the discretion of the knowledgeable 

agency program staff. We also reviewed our 2008 report in this area, 

which found that 22 of 119 fiscal year 2006 projects reported as EHS 

research were miscategorized, and recommended that the Director of the 

Office of Science and Technology Policy (OSTP), in consultation with the 

Directors of the National Nanotechnology Coordinating Office and OMB, 

provide better guidance to agencies on how to report nanotechnology 

EHS research.2

To identify the nanomaterials that the seven selected NNI member 

agencies focused on in their EHS research in fiscal year 2010, we 

reviewed qualitative project data—such as abstracts and progress 

reports—for those projects we determined were primarily directed at EHS. 

We also consulted with agency officials. One analyst identified, and a 

second analyst verified, the nanomaterials in the project documentation. 

We attempted to identify the nanomaterials that the projects actually 

studied in fiscal year 2010. However, some projects are multiyear efforts. 

The level of detail in the documentation we reviewed for each project 

varied, and the documentation did not always indicate which materials 

were studied in which years. For the purposes of our analysis, we 

assumed that all nanomaterials identified for a project were studied in 

2010, unless the documentation specified otherwise. It is possible that 

some additional nanomaterials were studied by these projects but not 

referenced in the documents we reviewed. It is also possible that some of 

the nanomaterials referenced in project documents were not actually 

studied until later years of a project. However, we do not have any 

reasons to suspect that such variances would be significant or would 

substantially change our findings.

We asked OMB and OSTP to identify any guidance 

provided to agencies on how to report their EHS research and to describe 

any steps taken since our prior report to improve such guidance.

We assigned each particular nanomaterial identified to one of five 

categories: carbon-based nanomaterials; metal-based nanomaterials; 

semiconductor-based nanomaterials; organic nanomaterials; and other 

nanomaterials. In addition, some projects were not targeted to particular 

nanomaterials. An analyst with previous academic and professional 

 

2

GAO, Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of 

Federal Research Focused on Environmental, Health, and Safety Risks, GAO-08-402 

(Washington, D.C.: Mar. 31, 2008).
Appendix I: Objectives, Scope, and 

Methodology

Page 57 GAO-12-427 Nanotechnology

experience in nanotechnology helped identify the categories we used and 

verified that the materials were placed in the appropriate categories for 

each project. After reviewing the fiscal year 2010 EHS research by the 

selected agencies, we selected the five categories of nanomaterials we 

used, based on the primary composition of the materials, to encompass 

the range of materials identified in the projects. To inform our selection of 

the categories we used for grouping nanomaterials, we reviewed 

literature related to nanotechnology EHS issues from federal agencies 

(NIH and EPA), nonprofit organizations (the Woodrow Wilson 

International Center for Scholars’ Project on Emerging Nanotechnologies 

and the World Technology Evaluation Center, Inc.), and a market 

research firm that tracks nanotechnology (Lux Research). We found that 

various classes or categories were used to present information on 

nanomaterials. For materials identified as composites, we assigned them 

to categories based on the primary nanomaterials from which they were 

formed—for example, we assigned carbon nanotube nanocomposites to 

the carbon-based nanomaterials category.

To determine the extent to which the NNI member agencies collaborate 

with stakeholders on nanotechnology EHS research and related 

strategies, we (1) discussed with agency officials how their agencies 

collaborate on nanotechnology EHS research and NNI’s role in facilitating 

that collaboration, and (2) we obtained documentation on these 

collaborative efforts. We conducted a review of formal collaborative 

efforts (i.e., those that are documented in written agreements) that 

focused on nanotechnology EHS research initiated from February 2008 to 

October 2011 while the 2008 NNI Strategy for Nanotechnology-Related 

EHS Research was in effect.3

 

3

NSTC, Committee on Technology, Subcommittee on Nanoscale Science, Engineering, 

and Technology, National Nanotechnology Initiative Strategy for Nanotechnology-Related 

Environmental, Health, and Safety Research (February 2008).

We chose this time frame because this 

strategy—the first NNI strategy to focus on EHS research—established 

collaboration as necessary for its implementation efforts. The strategy 

was in effect for a number of years, which allowed us to get a more 

complete picture of the number of collaborative projects completed during 

its implementation. We only included collaborative efforts that were 

formalized by written agreements because those provided a clearer 

description of the agencies’ contributions of resources. We obtained an 

initial list of such efforts from published NNI sources as well as an OMB 

data call used to compile EHS-related nanotechnology projects for the 
Appendix I: Objectives, Scope, and 

Methodology

Page 58 GAO-12-427 Nanotechnology

2011 NNI EHS research strategy. We sent our initial list to the selected 

NNI agencies for their review and revision, and analyzed supporting 

documents provided by the agencies. We provide relevant information 

from the supporting documents for each of the projects within our scope 

in appendix II.

We administered a web-based questionnaire to a nonprobability sample 

of nonfederal stakeholders,4 including those affiliated with academia, 

companies, nongovernmental organizations (NGO), and state and local 

governments, to obtain their views on collaboration with the NNI member 

agencies on EHS research and the EHS research strategies. Because 

the population of nonfederal stakeholders is diverse, wide-ranging, and 

difficult to reliably define, we chose to use a nonprobability sample of 

individuals who (1) had expertise in the field of nanotechnology, and (2) 

had interacted with the NNI in the past few years, or who were 

representatives of organizations and companies suggested to us through 

our scoping interviews. We identified relevant potential respondents from 

several sources, including the list of participants in NNI workshops that 

were used to solicit input for the 2011 NNI EHS research strategy5

 

4

A nonprobability sample is a sample in which some items in the population have no 

chance, or an unknown chance, of being selected. Results from nonprobability samples 

cannot be used to make inferences about a population. However, information from the 

sample provided illustrative examples.

and 

participants in a review of the NNI by the President’s Council of Advisors 

on Science and Technology. We also included members of 

nanotechnology-related trade associations and other organizations 

through interviews with nanotechnology experts using an iterative 

process, often referred to as “snowball sampling.” We excluded federal 

employees and contractors, individuals or organizations that are not 

located in the United States, and those for whom we could not obtain 

contact information. In addition, individuals who were not considered to 

have expertise in the nanotechnology field based on their job titles were 

5

In 2009 and 2010, the NNI held four public workshops: (1) Human and Environmental 

Exposure Assessment (February 2009); (2) Nanomaterials and the Environment & 

Instrumentation, Metrology, and Analytical Methods (October 2009); (3) Nanomaterials 

and Human Health & Instrumentation, Metrology, and Analytical Methods (November 

2009); and (4) Risk Management Methods & Ethical, Legal, and Societal Implications of 

Nanotechnology (March 2010). 
Appendix I: Objectives, Scope, and 

Methodology

Page 59 GAO-12-427 Nanotechnology

excluded.6

The questions included in the questionnaire were developed using issues 

raised in our scoping interviews and background literature search. Most of 

our questions provided respondents with answer options identified 

through our interviews and background literature searches. In certain 

cases, we also provided respondents with an “other” category which 

allowed them to write in additional responses we did not identify. 

However, because few respondents chose this option, we presented only 

some of these responses as illustrative examples. The questionnaire 

went through internal reviews, including independent GAO survey 

experts, as well as four pretests with two stakeholders who work for 

companies, one academic, and one stakeholder from an NGO. We chose 

the pretesters to reflect the diversity of affiliations of the nanotechnology 

experts included among our respondents. We revised and clarified the 

questions and introductory material to the questionnaire based on 

comments obtained in the internal reviews and from the pretesters.

These sources provided us with a list of 228 stakeholders 

chosen as potential respondents. Of these 228 individuals, five 

subsequently were excluded from our sample because they had invalid email addresses, were duplicates, or were not available for an extended 

period, giving us a final sample of 223 potential respondents. We 

categorized the population surveyed by affiliation type, usually based on 

information provided on each entity’s website, as follows: (1) “academic,” 

which includes universities or university-affiliated programs or centers; (2) 

“company,” which includes companies, corporations, or other for-profit 

entities whose primary purpose is to sell products, services, or 

information; (3) “organization,” which includes NGOs or other entities 

whose primary purpose is public interest or mutual benefit; and (4) “state 

and local government.” 

We administered the questionnaire through a secure server. When we 

completed the final survey questions and format, we sent an e-mail 

announcement of the questionnaire to the nonfederal stakeholders in our 

sample on September 23, 2011. Stakeholders were notified that the 

questionnaire was available online and were given unique passwords and 

user names on October 11, 2011. We sent follow-up e-mail messages on 

 

6

For example, administrative assistants or staff managers were excluded because they 

are unlikely to have subject matter expertise. In another case, an individual in a 

consultancy that does not focus on nanotechnology was excluded, based on advice from 

the head of a nanotechnology trade association.
Appendix I: Objectives, Scope, and 

Methodology

Page 60 GAO-12-427 Nanotechnology

October 18, 2011, October 25, 2011, and November 2, 2011 to those who 

had not yet responded. Then we contacted all nonrespondents by 

telephone, starting on October 21, 2011. The questionnaire was available 

online until December 6, 2011.

Because this was not a sample survey, it has no sampling errors. 

However, the practical difficulties of conducting any survey may introduce 

errors, commonly referred to as nonsampling errors. For example, 

difficulties in interpreting a particular question, sources of information 

available to respondents, or entering data into a database or analyzing 

them can introduce unwanted variability into the survey results. We took 

steps in developing the questionnaire, collecting the data, and analyzing 

them to minimize such nonsampling errors. For example, we worked with 

social science survey specialists to design the questionnaire. We 

pretested the draft questionnaire with four nonfederal stakeholders to 

ensure that the questions were relevant, clearly stated, and easy to 

understand. When we analyzed the data, an independent analyst 

checked all computer programs. Since this was a web-based 

questionnaire, respondents entered their answers directly into the 

electronic questionnaire, eliminating the need to key data into a database, 

minimizing error. 

Of the 223 potential respondents, 138 completed the questionnaire during 

our time frame, for an overall response rate of about 62 percent.7

To determine the extent the NNI strategy documents address desirable 

characteristics of national strategies, we compared three key NNI 

strategic documents

The 

numbers responding by affiliation type as categorized by us were 

(1) “academic”—42 out of 62; (2) “company”—65 out of 114; 

(3) “organization”—24 out of 39; and (4) “state and local government”— 

7 out of 8.

8

 

7

Not all individuals responded to every question.

against criteria for desirable characteristics of 

8

These three strategic documents are: (1) NSTC, Committee on Technology, 

Subcommittee on Nanoscale Science, Engineering, and Technology, National 

Nanotechnology Initiative Strategic Plan (February 2011); (2) NSTC, Committee on 

Technology, Subcommittee on Nanoscale Science, Engineering, and Technology, 

National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy 

(October 2011); and (3) NSTC, Committee on Technology, Subcommittee on Nanoscale 

Science, Engineering, and Technology, The National Nanotechnology Initiative 

Supplement to the President’s 2012 Budget (February 2011).
Appendix I: Objectives, Scope, and 

Methodology

Page 61 GAO-12-427 Nanotechnology

national strategies. Prior GAO reports have identified six desirable 

characteristics for national strategy documents that would help shape the 

policies, programs, priorities, resource allocations, and standards that 

would enable federal agencies and other stakeholders to implement the 

strategies and achieve the identified results.9 National strategies that 

address these characteristics offer policymakers and implementing 

agencies a management tool that can help ensure accountability and 

more effective results.10

Table 5: Elements of Desirable Characteristics of National Strategies

Table 5 provides the desirable characteristics 

and the elements we looked for.

Desirable characteristic Brief description Elements of characteristic

Purpose, scope, and 

methodology

Addresses why the strategy was 

produced, the scope of its coverage, 

and the process by which it was 

developed.

• Statement of broad or narrow purpose, as 

appropriate.

• How it compares and contrasts with other national 

strategies.

• What major functions, mission areas, or activities it 

covers. 

• Principles or theories that guided its development.

• Impetus for strategy (e.g., statutory requirement or 

event).

• Process to produce strategy (e.g., interagency task 

force; state, local, or private input).

• Definition of key terms.

Problem definition and risk 

assessment 

Addresses the particular national 

problems and threats the strategy is 

directed toward.

• Discussion or definition of problems, their causes, 

and operating environment.

• Risk assessment, including an analysis of threats and 

vulnerabilities.

• Quality of data available (e.g., constraints, 

deficiencies, and “unknowns”). 

 

9

GAO, National Capital Region: 2010 Strategic Plan is Generally Consistent with 

Characteristics of Effective Strategies, GAO-12-276T (Washington, D.C.: Dec. 7, 2011); 

Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer Federal Leadership 

Roles and an Effective National Strategy, GAO-07-781 (Washington, D.C.: Aug. 14, 

2007); Financial Literacy and Education Commission: Further Progress Needed to Ensure 

an Effective National Strategy, GAO-07-100 (Washington, D.C.: Dec. 4, 2006); Combating 

Terrorism: Evaluation of Selected Characteristics in National Strategies Related to 

Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004).

10GAO-07-781. 
Appendix I: Objectives, Scope, and 

Methodology

Page 62 GAO-12-427 Nanotechnology

Desirable characteristic Brief description Elements of characteristic

Goals, subordinate objectives, 

activities, and performance 

measures

Addresses what the strategy is trying 

to achieve, steps to achieve those 

results, as well as the priorities, 

milestones, and performance 

measures to gauge results.

• Overall results desired (i.e., “end-state”).

• Hierarchy of strategic goals and subordinate 

objectives.

• Specific activities to achieve results.

• Priorities, milestones, and outcome-related 

performance measures.

• Specific performance measures.

• Process for monitoring and reporting on progress.

• Limitations on progress indicators.

Resources, investments, and 

risk management

Addresses what the strategy will cost, 

the sources and types of resources 

and investments needed, and where 

resources and investments should be 

targeted by balancing risk reductions 

and costs.

• Resources and investments associated with the 

strategy.

• Types of resources required, such as budgetary, 

human capital, information technology, research and 

development, contracts.

• Sources of resources (e.g., federal, state, local, and 

private).

• Economic principles, such as balancing benefits and 

costs. 

• Resource allocation mechanisms, such as grants, inkind services, loans, or user fees.

• “Tools of government” (e.g., mandates or incentives 

to spur action).

• Importance of fiscal discipline.

• Linkage to other resource documents (e.g., federal 

budget).

• Risk management principles.

Organizational roles, 

responsibilities, and coordination

Addresses who will be implementing 

the strategy, what their roles will be 

compared to others, and mechanisms 

for them to coordinate their efforts.

• Roles and responsibilities of specific federal 

agencies, departments, or offices.

• Roles and responsibilities of state, local, private, and 

international sectors.

• Lead, support, and partner roles and responsibilities.

• Accountability and oversight framework.

• Potential changes to current organizational structure.

• Specific processes for coordination and collaboration.

• How conflicts will be resolved.

Integration and implementation Addresses how a national strategy 

relates to other strategies’ goals, 

objectives, and activities—and to 

subordinate levels of government and 

their plans to implement the strategy.

• Integration with other national strategies (horizontal).

• Integration with relevant documents from 

implementing organizations (vertical).

• Details on specific federal, state, local, or private 

strategies and plans.

• Implementation guidance.

• Details on subordinate strategies and plans for 

implementation (e.g., human capital, and enterprise 

architecture).

Source: GAO-04-408T. 
Appendix I: Objectives, Scope, and 

Methodology

Page 63 GAO-12-427 Nanotechnology

To assess whether the documents addressed these desirable 

characteristics, two analysts independently reviewed the three NNI 

strategy documents for the elements of each characteristic. We examined 

the documents for inclusion of each element and for sufficient specificity 

and detail. The two analysts compared their assessments, discussed any 

discrepancies, and agreed upon a determination for each element. Each 

characteristic was then given a rating of “address,” “partially address,” or 

“does not address.” According to our methodology, the strategy 

documents “address” a characteristic when it explicitly includes all, or 

nearly all, elements of the characteristic and has sufficient specificity and 

detail. The documents “partially address” a characteristic when it includes 

some or most of the elements with sufficient specificity and detail. The 

“partially address” category includes a range that varies from explicitly 

including most of the elements to including as few as one of the elements 

of a characteristic. A strategy “does not address” a characteristic when it 

does not include any elements of a characteristic or references are too 

vague or general to be useful.

Because the three NNI documents have different purposes and 

audiences, an individual document need not address each element of 

each desirable national strategy characteristic. Therefore, we reviewed 

the three NNI strategy documents as a whole. In the case of the 2011 

NNI strategic plan and Supplement to the President’s 2012 Budget, we 

focused on sections related to EHS research, where applicable.

We identified agency documents related to nanotechnology EHS 

research strategies and performance. Documents were identified based 

on interviews with agency officials, review of agency websites, and a data 

collection instrument sent to agencies requesting any documentation 

related to the planning or performance of their nanotechnology EHS 

research programs. In order to assess the extent of linkage between 

agencies’ nanotechnology EHS research and national priorities of the 

NNI, we evaluated agency management documents for explicit referrals 

to NNI activities or guidance, including strategic documents such as the 

NNI strategic plan or EHS research strategy, or activities of the NNI’s 

planning and coordinating bodies. We also reviewed agencies’ 

Performance Reports in order to assess agencies' use of performance 

information related to nanotechnology EHS research efforts.
Appendix I: Objectives, Scope, and 

Methodology

Page 64 GAO-12-427 Nanotechnology

We conducted this performance audit from February 2011 through May 

2012 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that the 

evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.
Appendix II: Collaborative Nanotechnology 

Environmental, Health, and Safety Research 

Agreements 

Page 65 GAO-12-427 Nanotechnology

Table 6 identifies collaborative nanotechnology EHS research project 

agreements initiated by the NNI member agencies included in our review 

from February 2008 to October 2011. The table identifies only those 

projects specifically focused on nanotechnology. All the information in the 

table is based on the written agreements, which were provided by NNI 

member agencies’ officials.

Appendix II: Collaborative Nanotechnology 

Environmental, Health, and Safety Research 

Agreements 
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 66 GAO-12-427 Nanotechnology

Table 6: Collaborative Nanotechnology Environmental, Health, and Safety Research Agreements

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

Consumer Product Safety 

Commission (CPSC), 

National Institute of 

Standards and Technology 

(NIST)

NA April 2008 Memorandum of 

understanding

Memorandum of 

understanding between 

CPSC and NIST’s Building 

and Fire Research 

Laboratory

Develop best practices to identify the presence of and 

characterize and quantify potential release of 

nanomaterials from flame retardant consumer products, 

to help assess the safety of these products. The 

cooperating agencies plan to work closely to expedite 

the development and availability of methods for the 

characterization and quantification of the release of 

nanomaterials from a variety of products (e.g., textiles, 

plastics) which are assessed using any of a number of 

standard fire tests.

CPSC, National Institute 

for Occupational Safety 

and Health (NIOSH)

NA July 2008 Interagency 

agreement

Nano product exposure 

assessment

Conduct laboratory investigations on the emissions of 

nanoscale titanium dioxide from selected consumer 

products. The project also is to involve developing the 

appropriate sampling and analysis methods for 

nanomaterials incorporated into selected consumer 

products. The first products to be investigated are 

bathroom cleaners that utilize titanium dioxide as a 

catalyst to destroy bacteria or to break down organic 

material. These products are believed to be used by 

consumers and in occupational settings (e.g., hotel 

cleaning). CPSC staff interests involve emissions during 

consumer use while NIOSH is concerned with emissions 

that occur in occupational use scenarios.

CPSC, NIST NA Initiated July 

2009, extended 

September 2009

Interagency 

agreement

Exposure and fire hazard 

assessment of 

nanoparticles in fire safe 

consumer products

Determine if nanoparticles that are traditionally used to 

improve the fire performance of foam and barrier fabrics 

are released during simulated normal conditions (i.e., 

mechanical compression and saliva). In addition, 

determine if the release of nanoparticles also creates a 

decrease in the fire performance of these components.

CPSC, NIOSH NA March 2010 Interagency 

agreement

Pulmonary effects of 

titanium dioxide 

nanoparticles released from 

aerosol spray products

Evaluate the acute bioactivity of a particulate aerosol 

from a bathroom cleaner or sanitizer containing titanium 

dioxide nanoparticles by exposing rats by inhalation to 

the aerosolized spray particles (low and high dose) for 2 

hours and monitor pulmonary responses at 1, 7, and 28 

days post-exposure.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 67 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

CPSC, NIOSH NA April 2010 Interagency 

agreement

Exposure assessment of 

silver nanoparticles in 

treated products

Use scientifically credible protocols to evaluate 

exposure potential to nanosilver from related products. 

NIOSH plans to test the broad hypothesis that 

nanosilver is released from products under conditions of 

intended use.

CPSC, EPA NA May 2010 Interagency 

agreement

Exposure assessment of 

silver nanoparticles in select 

children’s consumer 

products

Evaluate children’s potential exposures to nanosilver 

from consumer products marketed exclusively for 

children (e.g., pacifiers, plush toys) using scientifically 

credible protocols. EPA plans to test the broad 

hypothesis that nanosilver is released from children’s 

consumer products under conditions of intended use.

CPSC, NIOSH NA March 2011 Interagency 

agreement

Simulated worker exposure 

to silver from use of nanoenabled consumer products

Use scientifically defensible methods to evaluate the 

release of silver from consumer products and model 

exposure potential. NIOSH plans to test the broad 

hypothesis that silver is released from nanosilver 

enabled products under conditions of intended use in 

the work environment.

CPSC, NIOSH NA May 2011 Interagency 

agreement

Exposure assessment and 

pulmonary effects of silver 

nanoparticles released from 

aerosol spray products

Characterize the generated particulate from a product 

containing silver nanoparticles aerosol including the 

mass, particle size distribution, and chemical 

composition of the particles. NIOSH staff plan to expose 

rats by inhalation to the aerosolized spray particles (low 

and high dose) for 2 hours and monitor pulmonary 

responses at 1, 7, and 28 days post-exposure.

CPSC, NIST NA May 2011 Interagency 

agreement

Exposure assessment of 

carbon nanotubes in sports 

equipment

Determine if nanomaterials that are reported to be used 

in selected sports equipment are present in these 

products and are released during simulated use 

conditions. In addition, this project seeks to determine if 

the release of nanoparticles improve the performance of 

these products.

CPSC, NIST NA July 2011 Interagency 

agreement

Quantify and characterize 

released nanoparticles from 

thermoset and thermoplastic 

samples

Measure the impact of nanotechnologies on the 

flammability of the thermoplastic- and thermoset-based 

consumer products and develop risk models for human 

exposure to materials released from these consumer 

products.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 68 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

CPSC, NIST NA August 2011 Interagency 

agreement

Characterization of airborne 

nanoparticles released from 

consumer products

Develop testing and measurement protocols for 

determining the quantities and properties of 

nanoparticles released from flooring finishes and interior 

paints, and their subsequent airborne concentrations. 

Develop essential methods and data to assess the 

release as well as accumulation of nanoparticles at the 

surfaces of these products that seek to assist in 

estimating occupant exposure and developing strategies 

to manage and mitigate these exposures. 

CPSC, Environmental 

Protection Agency (EPA)a NA September 2011 Interagency 

agreement

Risk assessment for 

manufactured nanoparticles 

used in consumer products

Determine whether the nanoparticles exposures to 

humans and organisms resulting from consumer 

product and environmental exposures will substantially 

differ in both physicochemical and toxicological 

properties from nanoparticles that are newly 

synthesized in the laboratory or incorporated directly 

into a product. These differences may have significant 

consequences with respect to nanoparticles 

bioavailability and other toxicity measures. This study 

plans to test these measures in in vitro and in vivo

experiments, and produce mechanism-based results 

relating toxic effects to nanoparticles physicochemical 

properties.

CPSC, National Science 

Foundation (NSF)

NA September 2011 Interagency 

agreement

Interagency agreement 

between the CPSC and 

NSF

Develop innovative tools for measuring the potential 

health impact of nanotechnologies used in the 

flammability treatment of thermoplastic- and thermosetbased consumer products and develop risk models for 

human exposure to materials released from these 

consumer products.

EPA United Kingdom 

(UK) Natural 

Environment 

Research Council, 

UK Engineering and 

Physical Sciences 

Research Council, 

UK Department of 

Environment, Food, 

and Rural Affairs, UK 

Environment Agency

March 2009 Memorandum of 

understanding

Memorandum of 

understanding for a joint 

request for applications for 

nanotechnology research 

proposals

Establish a cooperative framework for the EPA, the UK 

Natural Environment Research Council, the UK 

Engineering and Physical Sciences Research Council, 

the UK Department of Environment, Food, and Rural

Affairs, and the UK Environment Agency to organize, 

plan, and execute a joint Request for Applications for 

research related to the environmental and health 

implications of released nanomaterials.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 69 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

EPA, NSF, U.S. 

Department of 

Agriculture’s National 

Institute of Food and 

Agriculture

NA Solicitation 

issued November 

2009

Grant or cooperative 

agreement

Increasing scientific data on 

the fate, transport, and 

behavior of engineered 

nanomaterials in selected 

environmental and 

biological matrices

Increase scientific knowledge on the partitioning of 

nanomaterials in various media and increase data on 

movement and transformation capacities. Address the 

urgent needs to scientifically understand the fate and 

properties of nanoscale materials and additives that 

may be used or introduced into foods. Assess the 

adequacy of the existing characterization methods to 

study the critical questions, and establish the baseline 

for the needs of new characterization methodology. 

Provide guidance on the extent of future investigation 

needs on the nanoscale food materials and additives.

EPA, NIST NA July 2011 Interagency 

agreement

Measurements to support 

research in nanoparticles

Investigate aggregation of engineered nanoparticles in 

an artifact of air sampling on filter media and investigate 

how engineered nanoparticles change microscopically 

with age in the atmosphere.

EPA International Life 

Sciences Institute 

Research 

Foundationb

September 2011 Contract Support for better 

understanding the release 

of nanomaterials to the 

environment workshop 

(Phase 2)

Evaluate the “state of the science” for release 

measurement for multi-walled carbon nanotubes in 

polymer. The project seeks to use information (methods, 

studies, guidance, etc.) collected in response to a data 

call and literature search and provide that information to 

groups of subject matter experts selected by the 

steering committee. This information is to also be made 

available in the project’s information catalogue to the 

extent it does not reveal confidential business 

information.

Food and Drug 

Administration (FDA), 

National Institutes of 

Health’s (NIH) National 

Cancer Institute (NCI), and 

NIST 

NA July 2009 Memorandum of 

understanding

Memorandum of 

understanding between the 

FDA, NCI, and NIST for the 

Nanotechnology 

Characterization Laboratory 

(NCL) and related 

nanotechnology activities

Facilitate the development of nanotechnologies that 

constitute novel research tools and safer, more effective 

cancer therapies by establishing a framework for 

effective risk identification, assessment, and evaluation 

of emerging products based on nanotechnology. This 

collaboration is to be focused primarily on the NCL and 

directly related activities.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 70 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

FDA’s Center for Biologics 

Evaluation and Research, 

NCL, NIST

Science Applications 

International 

Corporation (SAIC)-

Fredrickc

February 2011 Grant mechanism or 

other opportunities

In vitro evaluation of effects 

of engineered 

nanomaterials on blood 

platelets

Develop a panel of in vitro assays for evaluation of 

effects of nanomaterials on blood platelets. Research 

validation of the assays for different representative types 

of nanomaterials, soluble nanoparticles, and 

nanoobjects in suspension—representative metal, 

carbon, polymer, dendrimer, liposome nanoparticles, 

nanoparticles containing composites, or nanostructured 

macrosurfaces. Investigate a structure-function 

relationship of a nanoparticle-platelet interaction in a 

model of different size-charge modified 

poly(amidoamine) dendrimers.

FDA’s National Center for 

Toxicological Research, 

Center for Food Safety and 

Applied Nutrition, Center 

for Veterinary Medicine; 

National Toxicology 

Program; Pacific 

Northwest National 

Laboratories

NA February 2011 Grant mechanism or 

other opportunities

Development and 

evaluation of exposure 

dosimetry methods to 

optimize the standard in 

vitro mammalian 

genotoxicity assays for 

assessing engineered 

nanomaterials

Evaluate whether the existing in vitro mammalian 

genotoxicity assay is suitable for assessing the 

genotoxicity of nanomaterials. Explore the possible 

mechanisms underlying genotoxicity of engineered 

nanomaterials by conducting genomic analysis. Identify 

potential improvements to the assay and general 

strategies for evaluating nanomaterials. Examine 

whether the suitable methods and other experiences 

learned from the micronucleus assay are applicable to 

other genotoxicity tests, such as mouse lymphoma 

assay and in vivo micronucleus assay.

FDA, NCI, NCL SAIC-Fredrickc July, 2011 Interagency 

agreement

In vitro dermal penetration 

and in vivo distribution of 

nanoparticles used in food 

and cosmetics

Utilize free and surface model nanoparticles (such as 

dendrimers, nano-silver or nano-gold) with the size 

range typically found in food and cosmetics to assess 

their characteristics and correlate the effect of surface 

modification on the ability of nanomaterials to penetrate 

various tissue barriers in different in vitro and in vivo

systems. Supply information related to how 

nanomaterial physiochemical properties affect the ability 

of these nanoscale materials to interact with various 

biological systems and, as a result, to evaluate the 

benefits versus the risks when making regulatory 

approval decisions in order to facilitate the development 

and commercialization of safe nano-based cosmetics, 

foods, and other FDA-regulated products.

FDA’s Center for Food 

Safety and Applied 

Nutrition and National 

Center for Toxicological 

Research

Key Laboratory for 

Biomedical Effects of 

Nanomaterials and 

Nanosafety, Chinese 

Academy of 

Sciences

Fiscal year 2011 Grant mechanism or 

other opportunities

Use of electron spin 

resonance spectroscopy and 

biomarkers of oxidative 

damage to assess the safety 

of nanoscale materials used 

in cosmetics

Develop rapid and predictive tests to assess toxicity 

elicited by nanosized materials. The tests may be used 

by the agency and the regulated industry to identify 

potentially hazardous nanosized materials in cosmetic 

products.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 71 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIH’s National Institute of 

Environmental Health 

Sciences (NIEHS), NIOSH

NA Initiated in June 

2008 and 

extended in June 

2009 and March 

2010

Interagency 

agreement

Comprehensive 

toxicological assessment of 

occupationally-relevant 

exposures

Characterize workplace exposure to selected 

engineered nanoparticles. This proposal is to focus on 

addressing the lack of exposure data. Twelve field 

investigations at sites where engineered nanoparticles 

are handled and manufactured are to be conducted. 

The focus of these investigations is to be nanoparticles 

of interest to NIEHS and NIOSH.

NIEHS, NIOSH NA Initiated in 

February 2009 

and extended in 

December 2009

Interagency 

agreement

Cardiovascular toxicity 

assessment of subchronic 

inhalation exposure to 

fullerene C60

Evaluate potential cardiovascular toxicity of subchronic 

inhalation exposure to fullerene C60 in animal models 

using molecular and biochemical analysis of 

cardiovascular tissue and blood samples. The findings 

are to be correlated with the histopathological, particle 

distribution, and blood chemistry results being obtained 

in other National Toxicology Program studies of this 

proposal.

NCI, NIH’s National 

Institute of Biomedical 

Imaging and 

Bioengineering, NIEHS

NA Initiated in April 

2010 with 

NIEHS; NCI 

joined in 

September 2010

Direct citation 

agreement

Nano registry Establish an authoritative nanomaterial registry, whose 

primary function is to provide consistent and 

authoritative information on the biological and 

environmental interactions of well-characterized 

nanomaterials, as well as links to associated 

publications, modeling tools, computational results and 

manufacturing guidance. The registry seeks to provide a 

curated data source and assessment information on the 

health and environmental effects of well-characterized 

nanomaterials. A set of minimal information about 

nanomaterials, ontology, and standards are to be 

developed through a community effort with broad 

representation to establish the authoritativeness of the 

registry. 

NCI, NCL, NIEHS SAIC-Fredrickc April 2010 Direct citation 

agreement

NIEHS nanomaterial 

characterization and 

informatics

NIEHS requests NCI and SAIC-Fredrick support for 

physiochemical characterization of engineered 

nanomaterials. NCL seeks to provide data to support 

and compare in-house characterization from program 

grantees. Facilitate the dissemination of findings and 

provide maximum impact to the field by providing direct 

access to a database for inclusion of nanomaterials 

physiochemical characterization and biological response 

data.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 72 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIEHS, NIOSH NA November 2010 Interagency 

agreement

Comprehensive 

toxicological assessment of 

occupationally-relevant 

exposures

Identify and assess workplaces where select 

engineered nanomaterials are manufactured or used 

and characterize potential worker exposures to those 

nanomaterials. Address the lack of information available 

on the identity and location of manufacture or use of 

engineered nanomaterials with high commercial 

potential and the lack of worker exposure data. Conduct 

12 field investigations at sites where engineered 

nanomaterials are handled and manufactured. The 

focus of these investigations is to be on nanomaterials 

of interest to NIEHS and NIOSH. Give priority to 

materials on the Organisation for Economic Cooperation and Development’s list of representative 

manufactured nanomaterials as well as those that are 

receiving increased attention due to requests to 

manufacture, use, or distribute in the United States.

NIEHS, NIOSH NA March 2011 Interagency 

agreement

Durability of nanoscale 

cellulose fibers in artificial 

human lung fluids

Characterize the physicochemical properties and 

dissolution behaviors of nanoscale cellulose fiber 

materials in artificial lung fluids to determine their 

biodurability.

NIOSH Institute of 

Occupational 

Medicined

March 2009 Collaborative 

research

Risk assessment of 

engineered nanoparticles

Conduct short-term inhalation experiments in mice to 

investigate short-term kinetics and health effects (e.g., 

pulmonary, cardiovascular, and central nervous system 

responses) of one or two selected engineered 

nanoparticles. Develop risk assessment methods, 

including biomathematical models of exposure-dose 

response, sensitivity and uncertainty analyses, and 

extrapolation from in vivo studies in rodents to predict 

internal dose and risk in humans. Provide exposure data 

in workplaces where nanoparticles are produced or 

used and develop risk management strategies.

NIOSH University of 

Massachusetts, 

Lowell

June 2009 Contract Professional services for 

developing a guidance 

document: Safe Practices 

for Working with Engineered 

Nanomaterials in Research 

Laboratories

Review the available scientific literature, conduct 

empirical measurements in laboratories, and apply best 

professional judgment to the development of a draft 

guidance document on safe practices for engineered 

nanomaterials in research laboratories.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 73 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIOSH Rice University’s 

International Council 

on Nanotechnology 

(ICON)

August 2009 Contract Development and 

deployment of a wiki to 

share good risk 

management practices for 

engineered nanomaterials

Develop a workspace for good risk management 

practice information, housed on the ICON 

GoodNanoGuide wiki. Using wiki technology for sharing 

risk management information, successful practices, and 

case studies, seek to provide NIOSH stakeholders and 

the public with an easy to use, familiar, flexible, and 

comprehensive platform to obtain critical occupational 

safety and health information. Discussion forums can be 

established for users to collaborate on a wide range of 

topics, including novel facility design solutions, improved 

control technologies, or creative risk characterization 

techniques. New users can engage the experienced 

user community for nanomaterial management advice. 

Developing a wiki-based information sharing platform 

through ICON has the potential for reducing barriers to 

providing information to a government site. 

NIOSH, Department of 

Defense (DOD)

NA October 2009 Memorandum Examination of potential 

occupational exposures of 

engineered nanomaterial at 

the DOD: a preliminary 

framework for DOD and 

NIOSH

Evaluate environment, safety, and occupational health 

issues related to the creation, handling, and use of 

engineered nanomaterials at facilities across all DOD 

agencies. This partnership can be effected across the 

DOD or on an individual basis (Department of Army, 

Department of Navy, etc.), dependent upon the degree 

of interest and need for such environmental, safety, and 

occupational health evaluations.

NIOSH Battelle Memorial 

Institute Pacific 

Northwest Divisione

March 2010 Memorandum of 

understanding

Memorandum of 

understanding between 

Battelle Memorial Institute 

Pacific Northwest Division 

and NIOSH

Combine the capabilities of NIOSH and Battelle to 

advance the fundamental science supporting the safety 

assessment of nanotechnologies. Specifically, NIOSH 

and Battelle seek to engage in a joint research program 

studying the comparative toxicity of commercially 

important nanomaterials (e.g., single-walled carbon 

nanotubes and silica).

NIOSH Center for High-Rate 

Nanomanufacturing 

at the University of 

Massachusetts, 

Lowell

August 2010 Contract Engineering controls for 

nanomaterial handling

Use data from field research to evaluate the 

performance of available engineering controls and 

promote their use for nanomaterial manufacturing and 

handling. Develop guidance for safely handling 

nanomaterials.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 74 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIOSH ICON August 2010 Contract Develop and deploy a wiki 

to share good risk 

management practices for 

engineered nanomaterials: 

follow-on deployment and 

evaluation

Perform follow-on deployment and evaluation tasks of 

work from previously completed contract. The objective 

of the platform, now known as the GoodNanoGuide, is 

to contribute to safety and health excellence by creating 

a generally accessible repository of critical safety and 

health research findings and best practice information to 

assist users in developing and administering effective 

safety and health programs to be used during the 

research, production, and use of engineered 

nanomaterials. GoodNanoGuide content is being 

contributed from a variety of sources, including private, 

government, and academic safety, health, and 

environmental practitioners and from the various 

national and international consortia that have been 

created to foster good practices. The long-range intent 

is to have a virtual warehouse (or library) where health, 

safety, and environmental professionals and the public 

can go to share information and collaborate on 

particular topics. 

NIOSH, Occupational 

Safety and Health 

Administration

NA August 2010 Interagency 

agreement

Guidance for nanomaterials 

workers

Investigate and characterize potential hazards 

associated with manufactured nanomaterials, with the 

goals of developing and recommending occupational 

safety and health measures to protect workers who 

manufacture and handle these materials. Build upon 

ongoing collaboration to investigate a control-focused 

guidance strategy for assisting small business 

employers in identifying and controlling workplace 

chemical hazards.

NIOSH Lovelace Respiratory 

Research Institutef September 2010 Contract Deposition of carbon 

nanotubes in a human 

respiratory tract replica

Obtain measurement data on the deposition efficiency 

and size distribution of multi-walled carbon nanotubes 

and single-walled carbon nanotubes in a human 

respiratory tract replica. These data are to be used by 

NIOSH to calibrate and evaluate a preliminary 

biomathematical model to predict the deposition of 

airborne carbon nanotubes in the human respiratory 

tract. A key element of this research is to develop an 

approach to relate the carbon nanotubes particle 

morphology to their aerodynamic and diffusion 

diameters. 
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 75 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIOSH University of 

Massachusetts, 

Lowell, the Center 

for High-rate 

Nanomanufacturing

September 2010 Memorandum of 

understanding

NIOSH-Center for High-rate 

Nanomanufacturing 

partnership to advance 

research and guidance for 

occupational safety and 

health in nanotechnology

Advance workplace health and safety standards and 

practices and strengthen the resulting nanotechnology 

workforce. The Center for High-rate 

Nanomanufacturing, as a part of this partnership, seeks 

to collaborate with NIOSH to provide a state-of-the-art 

platform for the discovery and dissemination of 

fundamental knowledge in the emerging interdisciplinary

fields of nanotechnology, including nanoscience, 

nanoengineering, and nanobiotechnology for the 

purpose of jointly developing effective occupational 

safety and health guidance.

NIOSH College of 

Nanoscale Science 

and Engineering of 

the University at 

Albany—State 

University of New 

York

October 2010 Memorandum of 

understanding

NIOSH-College of 

Nanoscale Science and 

Engineering of the 

University at Albany 

partnership to advance 

research and guidance for 

occupational safety and 

health in nanotechnology

Establish a world-class intellectual and physical platform 

for occupational safety and health research, 

development, educational, and business initiatives 

leading to the discovery, demonstration, and 

deployment of new guidelines, recommendations, and 

findings relating to the potential human health impacts 

of exposure to engineered nanomaterials. 

NIOSH Applied Research 

Associates, Inc.g March 2011 Contract Development of a 

preliminary biomathematical 

model to predict deposition 

of carbon nanotubes and 

nanofibers in the respiratory 

tract of workers

Extend the carbon nanotubes deposition model to 

accommodate additional input data on both 

aerodynamic and diffusion diameters, and on particle 

number concentration as well as mass concentration. 

An acceptable extended model is to provide predictions 

of the deposition of carbon nanotubes of different sizes 

and shapes (i.e., single-walled carbon nanotubes and 

multi-walled carbon nanotubes) in the human respiratory 

tract. The model is to be calibrated and evaluated—

evaluation includes determining the particle properties 

and model parameters that provide the best predictions 

of multi-walled carbon nanotubes and single-walled 

carbon nanotubes deposition in the human respiratory 

tract replica. The carbon nanotubes deposition model is 

to be linked with an initial model to predict carbon 

nanotubes clearance and retention in the respiratory 

tract.

NIOSH ICON August 2011 Contract Develop content and 

evaluate dissemination 

through the 

GoodNanoGuide wiki

Develop focused content that includes new work 

practices and case studies, moderating the wiki, 

providing user support, and conducting an evaluation of 

the effectiveness of the GoodNanoGuide.
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 76 GAO-12-427 Nanotechnology

Participating federal 

agencies

Nonfederal 

partners Date initiated

Type of 

collaboration Title Purpose

NIOSH, NIST, DOD, 

Department of Energy

Over 20 private 

sector entities

Program first 

initiated in July 

2005; multiple 

site visits 

occurred 

between

February 2008 

and October 

2011

Letter of introduction Site visits by NIOSH for the 

purpose of evaluating 

engineered nanomaterials in 

the workplace

Enter nanomaterial manufacturing facilities to 

characterize process and evaluate the potential for 

worker exposure to nanoparticles. NIOSH may publish 

information from the overall study in the primary 

literature, and may supplement its Approaches to Safe 

Nanotechnology document on its website to incorporate, 

in a de-identified manner, observations or findings 

specific to work practices, exposure controls, or risk 

management practices that come from the visit that may 

be of benefit to the rest of the nanomaterial 

manufacturing community.

NIST, NIOSH, NIH Agreement with 

International Alliance 

for NanoEHS 

Harmonization;h

other partners for the 

alliance also include 

over 10 private 

entities and 

international 

organizations; 

Collaborators include 

the European 

Commission’s 

Institute for 

Reference Materials 

and Measurements

October 2008 Participation 

agreement

International Alliance for 

NanoEHS Harmonization

Create protocols for a limited number of in vitro and in 

vivo toxicology tests on a small number of 

representative nanoparticles to enable a “round robin” 

study with the goal to achieve inter-laboratory 

reproducibility of results and verify and/or validate 

predictability of in vitro assays for in vivo responses. 

This is to involve at least the use of nanomaterials and 

biologicals from a single source, and a single set of 

protocols. The implementation of a round robin 

laboratory set of tests based on these protocols. 

Ongoing and further development of protocols that take 

into consideration study design and methodology, 

nanomaterial physicochemical properties, and 

quantitative structure function relationships at the 

nanobio interface for in vitro and in vivo protocol 

development. A next phase is to involve round robin 

studies of common nanomaterials and biological 

systems, where independent laboratories are to choose 

a different set of agreed approaches to interrogate the 

biological end-points.

Source: GAO analysis based on formal collaborative EHS research project agreements provided by NNI member agencies’ 

officials.

a

This agreement funded a grant selected through the cooperative framework signed 

between EPA and the UK. 

b

The International Life Sciences Institute Research Foundation is a nonprofit organization 

based in Washington, D.C. that focuses on advancing the methods and application of 

science in risk assessment, human nutrition, and the prevention of obesity. 

c

SAIC-Fredrick is a wholly owned subsidiary of Science Applications International 

Corporation and operates exclusively under a single, long-term contract to the National 

Cancer Institute. 
Appendix II: Collaborative 

Nanotechnology Environmental, Health, 

and Safety Research Agreements 

Page 77 GAO-12-427 Nanotechnology

d

The Institute of Occupational Medicine is an independent organization based in the UK that 

produces research, consulting, and other services related to occupational and 

environmental health, hygiene, and safety. 

e

Battelle Memorial Institute is an independent research and development organization 

based in Columbus, Ohio. 

f

The Lovelace Respiratory Research Institute is a private biomedical research organization 

dedicated to improving public health through research on the prevention, treatment, and 

cure of respiratory disease. 

g

Applied Research Associates, Inc. is a research and engineering company based in 

Albuquerque, New Mexico. 

h

International Alliance for NanoEHS Harmonization consists of internationally recognized 

experts drawn from academia and other scientific institutions from around the world. It is 

currently chaired by the Centre for BioNano Interactions at University College, Dublin. 
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 78 

Frank Rusco, (202) 512-3841 or ruscof@gao.gov

In addition to the contact named above, Dan Haas (Assistant Director), 

Krista Anderson, Nirmal Chaudhary, Elizabeth Curda, Lorraine Ettaro, 

Alison O’Neill, Tind Shepper Ryen, Jeanette Soares, Ruth Solomon, Hai 

Tran, and Jack Wang made key contributions to this report.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments

(361261)
The Government Accountability Office, the audit, evaluation, and 

investigative arm of Congress, exists to support Congress in meeting its 

constitutional responsibilities and to help improve the performance and 

accountability of the federal government for the American people. GAO 

examines the use of public funds; evaluates federal programs and 

policies; and provides analyses, recommendations, and other assistance 

to help Congress make informed oversight, policy, and funding decisions. 

GAO’s commitment to good government is reflected in its core values of 

accountability, integrity, and reliability.

The fastest and easiest way to obtain copies of GAO documents at no 

cost is through GAO’s website (www.gao.gov). Each weekday afternoon, 

GAO posts on its website newly released reports, testimony, and 

correspondence. To have GAO e-mail you a list of newly posted products, 

go to www.gao.gov and select “E-mail Updates.”

The price of each GAO publication reflects GAO’s actual cost of 

production and distribution and depends on the number of pages in the 

publication and whether the publication is printed in color or black and 

white. Pricing and ordering information is posted on GAO’s website, 

http://www.gao.gov/ordering.htm. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 

TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card, 

MasterCard, Visa, check, or money order. Call for additional information.

Connect with GAO on Facebook, Flickr, Twitter, and YouTube. 

Subscribe to our RSS Feeds or E-mail Updates. Listen to our Podcasts. 

Visit GAO on the web at www.gao.gov. 

Contact:

Website: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470

Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-

4400, U.S. Government Accountability Office, 441 G Street NW, Room 

7125, Washington, DC 20548

Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, DC 20548

GAO’s Mission

Obtaining Copies of 

GAO Reports and 

Testimony

Order by Phone

Connect with GAO

To Report Fraud, 

Waste, and Abuse in 

Federal Programs

Congressional 

Relations

Public Affairs

Please Print on Recycled Paper.