Nanotechnology: Better Guidance Is Needed to Ensure Accurate	 
Reporting of Federal Research Focused on Environmental, Health,  
and Safety Risks (31-MAR-08, GAO-08-402).			 
                                                                 
The National Nanotechnology Initiative (NNI), administered by the
Office of Science and Technology Policy (OSTP), is a multiagency 
effort intended to coordinate the nanotechnology-related	 
activities of 25 federal agencies that fund nanoscale research or
have a stake in the results. Nanotechnology is the ability to	 
control matter at the scale of a nanometer--one billionth of a	 
meter. A key research area funded by some federal agencies	 
relates to potential environmental, health, and safety (EHS)	 
risks that may result from exposure to nanoscale materials.	 
Because of concerns about federal efforts to fund and prioritize 
EHS research, GAO was asked to determine (1) the extent to which 
selected agencies conducted such research in fiscal year 2006;	 
(2) the reasonableness of the agencies' and the NNI's processes  
to identify and prioritize such federal research; and (3) the	 
effectiveness of the agencies' and the NNI's process to 	 
coordinate this research. GAO reviewed quantitative and 	 
qualitative data from five federal agencies that provided 96	 
percent of fiscal year 2006 funding for EHS research.		 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-402 					        
    ACCNO:   A81453						        
  TITLE:     Nanotechnology: Better Guidance Is Needed to Ensure      
Accurate Reporting of Federal Research Focused on Environmental, 
Health, and Safety Risks					 
     DATE:   03/31/2008 
  SUBJECT:   Data integrity					 
	     Environmental protection				 
	     Environmental research				 
	     Federal agencies					 
	     Federal funds					 
	     Funds management					 
	     Hazardous substances				 
	     Health hazards					 
	     Health research programs				 
	     Interagency relations				 
	     Product safety					 
	     Public health					 
	     Reporting requirements				 
	     Requirements definition				 
	     Research and development				 
	     Research and development costs			 
	     Risk assessment					 
	     Risk factors					 
	     Risk management					 
	     Safety regulation					 
	     Safety standards					 

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GAO-08-402

   

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Report to Congressional Requesters: 

United States Government Accountability Office: 

GAO: 

March 2008: 

Nanotechnology: 

Better Guidance Is Needed to Ensure Accurate Reporting of Federal 
Research Focused on Environmental, Health, and Safety Risks: 

Nanotechnology: 

GAO-08-402: 

GAO Highlights: 

Highlights of GAO-08-402, a report to congressional requesters. 

Why GAO Did This Study: 

The National Nanotechnology Initiative (NNI), administered by the 
Office of Science and Technology Policy (OSTP), is a multiagency effort 
intended to coordinate the nanotechnology-related activities of 25 
federal agencies that fund nanoscale research or have a stake in the 
results. Nanotechnology is the ability to control matter at the scale 
of a nanometerï¿½one billionth of a meter. A key research area funded by 
some federal agencies relates to potential environmental, health, and 
safety (EHS) risks that may result from exposure to nanoscale 
materials. Because of concerns about federal efforts to fund and 
prioritize EHS research, GAO was asked to determine (1) the extent to 
which selected agencies conducted such research in fiscal year 2006; 
(2) the reasonableness of the agenciesï¿½ and the NNIï¿½s processes to 
identify and prioritize such federal research; and (3) the 
effectiveness of the agenciesï¿½ and the NNIï¿½s process to coordinate this 
research. GAO reviewed quantitative and qualitative data from five 
federal agencies that provided 96 percent of fiscal year 2006 funding 
for EHS research. 

What GAO Found: 

The NNI reported that in fiscal year 2006, federal agencies devoted 
$37.7 millionï¿½or 3 percent of the $1.3 billion total nanotechnology 
research fundingï¿½to research that was primarily focused on the EHS 
risks of nanotechnology. However, about 20 percent of this total cannot 
actually be attributed to this purpose; GAO found that 22 of the 119 
projects identified as EHS-related by five federal agencies in fiscal 
year 2006 were not focused on determining the extent to which 
nanotechnology poses an EHS risk. Instead, the focus of many of these 
projects was to explore how nanotechnology could be used to remediate 
environmental damage or to detect a variety of hazards. GAO determined 
that this mischaracterization is rooted in the current reporting 
structure which does not allow these types of projects to be easily 
categorized and the lack of guidance for agencies on how to apportion 
funding across multiple topics. In addition to the EHS funding totals 
reported by the NNI, federal agencies conduct other research that is 
not captured in the totals. This research was not captured by the NNI 
because either the research was funded by an agency not generally 
considered to be a research agency or because the primary purpose of 
the research was not to study EHS risks. 

Federal agencies and the NNI are currently in the process of 
identifying and prioritizing EHS risk research needs; the process they 
are using appears reasonable overall. For example, identification and 
prioritization of EHS research needs is being done by the agencies and 
the NNI. The NNI also is engaged in an iterative prioritization effort 
through its Nanotechnology Environmental and Health Implications (NEHI) 
working group. NEHI has identified five specific research priorities 
for five general research categories, but it has not yet completed the 
final steps of this process, which will identify EHS research gaps, 
determine specific research needed to fill those gaps, and outline a 
long-term, overarching EHS research strategy. GAO found that the focus 
of most EHS research projects underway in fiscal year 2006 was 
generally consistent with agency priorities and NEHI research 
categories and that the projects focused on the priority needs within 
each category to varying degrees. The anticipated EHS research strategy 
is expected to provide a framework to help ensure that the highest 
priority needs are met. 

Agency and NNI processes to coordinate activities related to potential 
EHS risks of nanotechnology have been generally effective. The NEHI 
working group has convened frequent meetings that have helped agencies 
identify opportunities to collaborate on EHS risk issues, such as joint 
sponsorship of research and workshops to advance knowledge and 
facilitate information-sharing among the agencies. In addition, NEHI 
has incorporated several practices that are key to enhancing and 
sustaining interagency collaboration, such as leveraging resources. 
Finally, agency officials GAO spoke with expressed satisfaction with 
the coordination and collaboration on EHS risk research that has 
occurred through NEHI. They cited several factors they believe 
contribute to the groupï¿½s effectiveness, including the stability of the 
working group membership and the expertise and dedication of its 
members. 

What GAO Recommends: 

GAO is recommending that OSTP provide better guidance to agencies 
regarding how to report research that is primarily focused on EHS 
risks. In commenting on a draft of this report, OSTP generally agreed 
with the findings and will review the manner in which agencies respond 
to current guidance. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-402]. For more 
information, contact Anu Mittal at (202) 512-3841 or [email protected]. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Almost 20 Percent of EHS Research Projects Were Not Primarily Focused 
on Studying the EHS Risks of Nanotechnology: 

Processes to Identify and Prioritize Needed EHS Research Appear 
Reasonable and Are Ongoing but a Comprehensive Research Strategy Has 
Not Yet Been Developed: 

Coordination Processes Have Fostered Interagency Collaboration and 
Information-Sharing: 

Conclusions: 

Recommendation for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Comments from the Office of Science and Technology Policy: 

Appendix II: Comments from the Department of Health and Human Services: 

Appendix III: Comments from the National Institute of Standards and 
Technology: 

Appendix IV: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Federal Agencies Participating in the National Nanotechnology 
Initiative, as of December 2007: 

Table 2: GAO Analysis of the Number and Dollar Value of Nanotechnology 
Research Projects Reported by Selected Agencies as Being Primarily 
Focused on Environmental, Health, and Safety Risks, Fiscal Year 2006: 

Table 3: Research Primarily Focused on the Environmental, Health, and 
Safety Risks of Nanotechnology by Agency and Specific Nanotechnology 
Environmental and Health Implications Working Group Research Priority: 

Table 4: Examples of Agency Collaborations Related to Potential EHS 
Risks of Nanotechnology: 

Figures: 

Figure 1: Nanotechnology EHS Research by Agency, as Reported by the 
National Nanotechnology Initiative, Fiscal Year 2006: 

Figure 2: National Nanotechnology Initiative Structure: 

Figure 3: Nanotechnology Research Funding by Program Component Area, 
Fiscal Year 2006: 

Abbreviations: 

CPS: CU.S. Consumer Product Safety Commission: 

EHS: environmental, health, and safety: 

EPA: Environmental Protection Agency: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

NEHI: Nanotechnology Environmental and Health Implications (working 
group): 

NIH: National Institutes of Health: 

NIOSH: National Institute for Occupational Safety and Health: 

NIST: National Institute of Standards and Technology: 

NNCO: National Nanotechnology Coordinating Office: 

NNI: National Nanotechnology Initiative: 

NSET: Nanoscale Science, Engineering, and Technology (subcommittee): 

NSF: National Science Foundation: 

NSTC: National Science and Technology Council: 

OMB: Office of Management and Budget: 

OSHA: Occupational Safety and Health Administration: 

OSTP: Office of Science and Technology Policy: 

PCA: program component area: 

United States Government Accountability Office: 

Washington, DC 20548: 

March 31, 2008: 

The Honorable Daniel K. Inouye: 
Chairman: 
The Honorable Mark L. Pryor: 
The Honorable Gordon H. Smith: 
Committee on Commerce, Science, and Transportation: 
United States Senate: 

The Honorable Ron Wyden: 
The Honorable Richard Burr: 
Congressional Nanotechnology Caucus: 
United States Senate: 

Nanotechnology encompasses a wide range of innovations based on the 
understanding and control of matter at the scale of nanometers--the 
equivalent of one-billionth of a meter. For illustration, a sheet of 
paper is about 100,000 nanometers thick, a human hair is about 80,000 
nanometers wide, and 2 gold atoms lying side by side are about 1 
nanometer long. At the nanoscale level, some materials may exhibit 
electrical, magnetic, biological, and other properties that differ 
significantly from properties the same materials exhibit at a larger 
scale. For example, opaque materials, such as copper, become 
transparent at the nanoscale and inert materials, such as platinum and 
gold, become chemical catalysts. Exploiting the differences in the size 
and properties of materials at the nanoscale level has led to a range 
of commercial uses and holds the promise for innovations in virtually 
every industry from aerospace and energy to health care and 
agriculture. In 2006, an estimated $50 billion in products worldwide 
incorporated nanotechnology and this figure has been projected to grow 
to $2.6 trillion by 2014, according to an industry analyst. The Woodrow 
Wilson International Center for Scholars' Project on Emerging 
Nanotechnologies has identified over 500 consumer products that already 
are available to consumers that may contain nanoscale materials. For 
example, nanoscale materials have been embedded into clothing fabric to 
repel stains. Some nanoscale materials in development could greatly 
improve pharmaceuticals because the materials' size, structure, and 
behavior can be used, for example, to treat diseases by delivering 
drugs directly to affected cells, such as tumor cells. Food companies 
also are experimenting with nanoscale materials that can be 
incorporated into food packaging to detect spoilage or pathogens, and 
cosmetics companies have developed products with nanoscale materials 
that reportedly enable sunscreens to perform better. 

While the use of nanoscale materials holds much promise for the future, 
the small size and unique properties of nanomaterials raise questions 
about potential environmental, health, and safety (EHS) effects-- 
referred to as EHS risks--that might result from exposures during the 
manufacture, use, and disposal or recycle of nanoscale materials. For 
example, recent research suggests that nanomaterials are small enough 
to get inside cells and some may cross the blood-brain barrier to 
directly enter the central nervous system. Because nanotechnology is a 
relatively new science, basic information about the properties of many 
nanoscale materials is not fully known. Scientists are working to fill 
significant gaps in current knowledge about nanoscale materials so they 
can answer questions about potential EHS risks and help ensure the safe 
commercial development of these materials. 

In 2001, the National Nanotechnology Initiative (NNI) was established 
as a federal, multiagency effort intended to accelerate the discovery, 
development, and deployment of nanoscale science, engineering, and 
technology to achieve economic benefits, enhance the quality of life, 
and promote national security.[Footnote 1] The NNI is a mechanism to 
coordinate the nanotechnology-related activities of the 25 currently 
participating federal agencies that fund nanoscale research or have a 
stake in the outcome of this research, such as those agencies that may 
regulate products containing nanomaterials.[Footnote 2] While the NNI 
is designed to facilitate intergovernmental cooperation and identify 
overarching goals and priorities for nanotechnology research, it is not 
a research program. It also has no funding or authority to dictate the 
nanotechnology research agenda for participating agencies or to ensure 
that adequate resources are available to achieve specific goals. 
Instead, participating agencies develop and fund their own 
nanotechnology research agendas. In fiscal year 2006, 13 of the 25 
participating agencies in the NNI allocated a total of about $1.3 
billion from their appropriated budgets to nanotechnology research and 
development activities. 

Management of the NNI falls under the purview of the National Science 
and Technology Council (NSTC), a Cabinet-level body within the Office 
of the President that coordinates science and technology policy across 
the federal government. The NSTC's Committee on Technology has 
established a Nanoscale Science, Engineering, and Technology (NSET) 
subcommittee to help coordinate, plan, and implement the NNI's 
activities across participating agencies. In 2003, the NSET 
subcommittee further established a Nanotechnology Environmental and 
Health Implications (NEHI) working group.[Footnote 3] The purpose of 
the NEHI working group, composed of representatives from 16 research 
and regulatory agencies, is to, among other things, coordinate agency 
efforts related to EHS risks of nanotechnology. As is the case with the 
NNI, the NEHI working group has no authority to mandate research 
priorities or to ensure that agencies adequately fund particular 
research. 

In December 2003, Congress enacted the 21st Century Nanotechnology 
Research and Development Act.[Footnote 4] The act establishes a 
National Nanotechnology Program to coordinate federal nanotechnology 
research and development. Among other things, the act directs the NSTC 
to establish goals and priorities for the program and to set up program 
component areas that reflect those goals and priorities. To implement 
these requirements, the NSTC has established a process to categorize 
research projects and activities undertaken by the various federal 
agencies into seven areas. Of these seven, six are focused on the 
discovery, development, and deployment of nanotechnology, while the 
seventh relates to the societal dimensions of nanotechnology that 
include issues such as the EHS risks of nanotechnology. Agencies also 
report their research funding for each area to the Office of Management 
and Budget (OMB) as part of the annual federal budget process. NNI's 
annual Supplement to the President's Budget, prepared by the NSTC, 
includes EHS research figures from the agencies and a general 
description of the research conducted by the agencies in each of the 
seven areas. For reporting purposes, the NSET subcommittee has defined 
EHS research as "efforts whose primary purpose is to understand and 
address potential risks to health and to the environment posed by this 
technology." Eight of the 13 agencies that dedicated a portion of their 
research budgets for nanotechnology research in fiscal year 2006 
reported having devoted some resources to research that had a primary 
focus on potential EHS risks. However, the Woodrow Wilson International 
Center for Scholars has questioned the accuracy of reporting research 
related to EHS risks. Furthermore, some groups, including industry, 
environmental advocacy, and nonprofit research institutes, have raised 
concerns about the pace of NEHI's prioritization activities as well as 
the process it is using to identify research priorities and coordinate 
federal research. 

In this context you asked us to report on (1) the extent to which 
selected research and regulatory agencies conducted research in fiscal 
year 2006 that primarily was focused on the potential EHS risks of 
nanotechnology; (2) the reasonableness of the processes that agencies 
and the NNI use to identify and prioritize federal research on the 
potential EHS risks of nanotechnology; and (3) the effectiveness of the 
processes that agencies and the NNI use to coordinate their research. 

To determine the extent to which selected research and regulatory 
agencies conducted research that is primarily focused on studying the 
EHS risks of nanotechnology, we gathered data on the funding that NNI's 
participating agencies have used for EHS risk research. We focused our 
review on the Environmental Protection Agency (EPA), the National 
Institutes of Health (NIH), the National Institute for Occupational 
Safety and Health (NIOSH), the National Institute of Standards and 
Technology (NIST), and the National Science Foundation (NSF), because 
these five agencies accounted for 96 percent of the EHS research 
funding reported in fiscal year 2006. Of these agencies, NIH, NIOSH, 
NIST, and NSF are research agencies that have specific budgets to 
support research, including nanotechnology-related research. EPA on the 
other hand is a regulatory agency that also conducts research and 
therefore has a research budget. In addition to the agencies mentioned 
above, we also included in our review three regulatory agencies that do 
not have research budgets--the U.S. Consumer Product Safety Commission 
(CPSC), the Food and Drug Administration (FDA), and the Occupational 
Safety and Health Administration (OSHA) to determine whether these 
three agencies conducted any research on their own relative to EHS 
risks of nanotechnology. We assessed the reliability of the agencies' 
data and determined it was sufficient for the purposes of this 
analysis. To assess whether or not the primary purpose of the research 
conducted by these agencies addressed the EHS risks of nanotechnology, 
we reviewed qualitative data on all projects funded by EPA, NIH, NIOSH, 
NIST, and NSF in fiscal year 2006. To minimize bias and to ensure the 
consistency of our evaluation, the team independently conducted project 
reviews by using publicly available and agency documentation, such as 
project abstracts or grant applications, to make our determinations. 
For categorization of projects that appeared questionable to us, we 
discussed the categorization with agency officials and modified our 
determination as appropriate given the additional support provided by 
the agency. 

To determine the reasonableness of the process that the agencies and 
the NNI used to prioritize and coordinate federal research on studying 
EHS risks, we collected and reviewed documentation on research 
priorities, and the process used to establish these priorities, at each 
of the eight agencies included in our review and compared these 
priorities with funded research within the agency. To review the 
process being used by the NNI to identify and establish government-wide 
priorities, we reviewed NNI documents and interviewed agency officials 
and external stakeholder groups, including officials from groups that 
represent environmental and industry concerns. We compared the NNI's 
identified priorities with those identified by the agencies to 
determine whether they were consistent. We also compared the NNI's 
identified priorities with agency project-level data on EHS research 
underway in fiscal year 2006 to determine whether the projects were 
reflective of NNI's identified priorities. We did not determine whether 
the NNI's identified priorities represented a scientific consensus on 
the most appropriate ones. We interviewed agency officials at each of 
the eight agencies about the extent to which their agency's research 
priorities were met, either through the agency's own research or 
research conducted by other agencies. With regard to coordination, we 
discussed with agency and NNI officials how agencies coordinate 
research and NNI's role to facilitate that coordination, and we 
obtained documentation on these collaborative efforts. Furthermore, we 
compared the NNI's efforts to facilitate interagency collaboration with 
established practices that have been found to enhance and sustain 
collaboration among federal agencies. In addition, we interviewed 
stakeholders, including environmental and industry groups, to obtain 
views on agency coordination efforts. We conducted this performance 
audit from June 2007 to February 2008 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. 

Results in Brief: 

Of the $1.3 billion that federal agencies allocated to nanotechnology 
research in fiscal year 2006, the NNI reported that about $37 million 
was devoted to research that primarily focused on studying the EHS 
risks of nanotechnology. However, based on our analysis, about one- 
fifth of this amount cannot actually be attributed to this purpose. 
Specifically, our analysis found that 22 of the 119 projects identified 
as EHS projects by EPA, NIH, NIOSH, NIST, and NSF in fiscal year 2006 
were not primarily related to understanding the EHS risks of 
nanotechnology. These 22 projects, funded by NSF and NIOSH, accounted 
for about $7 million of the $37 million that the NNI reported as being 
primarily focused on EHS risks. Instead of determining the extent to 
which nanotechnology poses an EHS risk, the primary purpose of many of 
these projects was to explore how nanotechnology could be applied to 
remediate environmental damage or could be used to detect a variety of 
hazards, such as chemical or biological. The miscategorization of these 
22 projects results largely from a reporting structure for 
nanotechnology research that does not easily allow agencies to 
recognize projects that use nanotechnology to mitigate environmental 
damage or enhance detection of environmental contaminants and from the 
lack of guidance available to the agencies on how to apportion funding 
across multiple topics, when appropriate. As a result, agency officials 
said they characterized these projects as being EHS-focused for lack of 
a more closely related category to place them in. We also determined 
that some federal agencies conduct research that is not reported as 
part of EHS research funding and is therefore not captured in the EHS 
totals provided by the NNI. For example, NIH has research underway to 
develop drug delivery mechanisms that use nanotechnology. This research 
also will provide relevant health and safety information on how 
nanomaterials interact with the body at the cellular level, but the 
agency's funding for this type of research is not included in the NNI's 
totals for EHS research because studying EHS risks was not its primary 
purpose. We are recommending that the Office of Science and Technology 
Policy (OSTP), in consultation with the NNI and OMB, provide better 
guidance to agencies regarding how to report research that is primarily 
focused on understanding or addressing the EHS risks of nanotechnology. 
In commenting on this report, OSTP generally concurred with the 
report's findings and agreed to review the manner in which agencies 
respond to the current guidance at future NSET meetings. 

The agencies and the NNI are currently in the process of identifying 
and prioritizing EHS risk research needs; the process they are using 
appears reasonable overall. Identification and prioritization of 
research needs related to EHS risks takes place within individual 
agencies as well as within the NNI. Agencies' priorities are linked to 
their missions and are generally set by intra-agency teams dedicated to 
nanotechnology issues. Most of the eight agencies we reviewed have 
established internal task forces to identify and prioritize 
nanotechnology research needs and to communicate these priorities to 
the larger research community. In addition to these agency efforts, the 
NSET subcommittee is currently engaged in an iterative prioritization 
effort through its NEHI working group. This effort began with a 
September 2006 report in which NEHI identified five general categories 
of research necessary to evaluate EHS risks and a list of 75 specific 
research needs, which were not prioritized at that time. Subsequently, 
in an August 2007 report, NEHI distilled the list of 75 specific 
research needs into a set of five prioritized needs under each of the 
five general research categories. Agency officials told us that NEHI's 
report generally reflects their agencies' key research priorities. NEHI 
has not yet completed the final steps of this process and plans to 
issue a report in early 2008 that will identify EHS research gaps; 
determine specific research needed to fill those gaps; and outline a 
long-term, overarching strategy to guide agency research funding 
decisions. Furthermore, our analysis of the 97 research projects that 
were underway in fiscal year 2006 that were primarily related to 
studying EHS risks found that the focus of these projects was generally 
consistent with agency priorities and NEHI's five general research 
categories and that the projects focused on the priority needs within 
each category to varying degrees. The anticipated 2008 NEHI report is 
expected to provide a framework to help agencies better target the 
highest priority research needs in the future. Also, some environmental 
and industry groups have advocated for a more top-down and directed 
approach for setting and funding federal nanotechnology research 
priorities. However, such a structure and approach is generally 
inconsistent with historical approaches used to set federal research 
priorities and may be difficult to implement given how federal research 
is currently funded. 

Agency and NNI processes to coordinate activities related to the 
potential EHS risks of nanotechnology have been generally effective. 
The NEHI working group has convened frequent meetings, augmented by 
informal discussions among agencies, that have helped agencies identify 
opportunities to collaborate on EHS risk issues. These interagency 
collaborations have taken many forms including joint sponsorship of EHS-
related research and workshops and detailing staff to work at other 
NEHI participating agencies. These types of exchanges, according to 
most agency officials we spoke with, have helped advance knowledge and 
facilitated information-sharing among the agencies. In addition, NEHI 
has incorporated several practices that we have previously identified 
as key to enhancing and sustaining interagency collaborative efforts, 
such as defining a common outcome and leveraging resources, but has not 
completed an overarching strategy to help better align agencies' EHS 
research efforts. Finally, all agency officials we spoke with expressed 
satisfaction with both the coordination and the collaboration on EHS 
risk research that has occurred through NEHI. These officials cited 
several factors that they believe have contributed to the working 
group's effectiveness, including the expertise, dedication, and low 
turnover rate of its members. Furthermore, according to these 
officials, this stability, combined with common research needs and 
general excitement about the new science, has resulted in a collegial, 
productive working environment. 

Background: 

Nanotechnology is generally defined as the ability to understand and 
control matter at the nanoscale (between 1 and 100 nanometers), in 
order to create materials, devices, and systems with fundamentally new 
properties and functions specific to that scale. For example, opaque 
materials, such as copper, become transparent at the nanoscale and 
inert materials, such as platinum and gold, become chemical catalysts. 
With the capacity to control and manipulate matter at this scale, 
nanotechnology promises advances in areas such as new drug delivery 
systems, more resilient materials and fabrics, stronger materials at a 
fraction of the weight, more efficient energy conversion, and 
dramatically faster computer chips. 

To guide federal development of this technology, the National 
Nanotechnology Initiative (NNI) was established in fiscal year 2001 to 
support long-term research and development aimed at accelerating the 
discovery, development, and deployment of nanoscale science, 
engineering, and technology. The NNI is a multiagency program involving 
nanotechnology-related activities of the 25 federal agencies currently 
participating, including the National Science Foundation (NSF), the 
Department of Defense, the Department of Energy, the National 
Institutes of Health (NIH), and the National Institute of Standards and 
Technology (NIST). See table 1 for a complete listing of federal 
agencies participating in the NNI as of December 2007. 

Table 1: Federal Agencies Participating in the National Nanotechnology 
Initiative, as of December 2007: 

Federal Agencies with Budgets Dedicated to Nanotechnology Research and 
Development: 
* Cooperative State Research, Education, and Extension Service; 
* Department of Defense; 
* Department of Energy; 
* Department of Homeland Security; 
* Department of Justice; 
* Department of Transportation; 
* Environmental Protection Agency; 
* National Aeronautics and Space Administration; 
* National Institute of Standards and Technology; 
* National Institute for Occupational Safety and Health; 
* National Institutes of Health; 
* National Science Foundation; 
* U.S. Forest Service; 

Other Participating Agencies: 
* Bureau of Industry and Security; 
* Department of Education; 
* Department of Labor; 
* Department of State; 
* Department of the Treasury; 
* Food and Drug Administration; 
* International Trade Commission; 
* Intelligence Advanced Research Projects Activity; 
* Nuclear Regulatory Commission; 
* U.S. Consumer Product Safety Commission; 
* U.S. Geological Survey; 
* U.S. Patent and Trademark Office. 

Source: NNI. 

[End of table] 

Federal support for nanotechnology research totaled about $1.3 billion 
in fiscal year 2006. Cumulatively through fiscal year 2006, federal 
agencies have devoted over $5 billion to nanotechnology research since 
the NNI's inception. While not all of the NNI's participating agencies 
conduct or sponsor research, in fiscal year 2006, 13 agencies had 
budgets dedicated to nanotechnology research and development. Eight of 
these 13 agencies devoted some of their research resources to studying 
the environmental, health, and safety (EHS) risks of nanotechnology. Of 
these eight agencies, five--EPA, NIH, NIOSH, NIST, and NSF--accounted 
for almost 96 percent of the research focused on EHS risks in fiscal 
year 2006. NSF alone accounted for about 56 percent of all federal EHS 
risk research in fiscal year 2006. See figure 1 for a break out of 
research funds used by agency. 

Figure 1: Nanotechnology EHS Research by Agency, as Reported by the 
National Nanotechnology Initiative, Fiscal Year 2006: 

This figure is a pie chart showing nanotechnology EHS research by 
agency, as reported by the National Nanotechnology Initiative, fiscal 
year 2006. 

Dollars in millions. 

NSF: $21.0: 56%; 
NIH: $5.2: 14%; 
NIOSH: $3.8: 10%; 
EPA: $3.7: 10%; 
NIST: $2.4: 6%; 
Other agency: $1.6: 4%. 

[See PDF for image] 

Source: GAO analysis of NNI budget data. 

[End of figure] 

A number of research and regulatory agencies support research to 
advance knowledge and information about the potential EHS risks of 
nanotechnology: 

* The National Institute for Occupational Health and Safety (NIOSH) is 
a research agency within the Department of Health and Human Services 
(HHS) that concentrates its research on topics related to human health. 
NIOSH's research results in recommendations for preventing work-related 
injuries, illnesses, and death. It therefore focuses on studies that 
will improve scientists' ability to identify potential adverse 
occupational health effects of nanomaterials. 

* At NIH, another HHS research agency that concentrates on human 
health, nanotechnology research is generally focused on the development 
of medical applications and the protection of public health, including 
research to examine the interaction of nanomaterials with biological 
systems. 

* Consistent with its mission to advance measurement science, 
standards, and technology to enhance economic security and improve our 
quality of life, the National Institute of Standards and Technology 
(NIST), an agency in the Department of Commerce, develops the 
measurement techniques required to better characterize potential 
impacts of nanotechnology. 

* The National Science Foundation (NSF) has the broadest research 
portfolio relative to nanotechnology and supports research to help meet 
its mission to promote the progress of science and engineering. With 
regard to EHS risks, NSF sponsors research to develop new methods to 
characterize nanoparticles and investigate the environmental 
implications and toxicity of nanomaterials. In addition, NSF sponsors a 
network of research centers that focus on a range of EHS issues 
including occupational safety during nanomanufacturing and the 
interaction of nanomaterials and cells. 

In addition to these research agencies, a number of regulatory agencies 
also have an interest in developing information about the potential EHS 
risks of nanotechnology: 

* The Environmental Protection Agency (EPA), which is both a research 
and regulatory agency, is tasked with protecting human health and the 
environment. As a result, EPA determined that it needed to develop a 
better understanding of the potential human health and environmental 
risks from exposure to nanoscale materials and is therefore focusing 
its research efforts in this area, among others. 

* The Food and Drug Administration (FDA), another HHS agency, is 
generally responsible for overseeing the safety and effectiveness of 
drugs and devices for humans and animals, and of biological products 
for humans. The agency also is generally responsible for overseeing the 
safety of color additives, cosmetics, and foods, including food 
additives and dietary supplements. As a result, FDA is interested in 
understanding the potential risks posed by nanomaterials used in 
products under its jurisdiction. 

* The Occupation Safety and Health Administration (OSHA) is a 
Department of Labor agency whose mission is, in part, to ensure the 
safety and health of workers by setting and enforcing standards and 
encouraging continual improvement in workplace safety and health. OSHA 
is interested in information that would aid in the application of 
existing health standards--including hazard communication, respiratory 
protection programs, and laboratory standards--to nanotechnology 
operations and help determine the need for new standards or guidance 
products. 

* The mission of the U.S. Consumer Product Safety Commission (CPSC) is 
to protect the public from unreasonable risks of serious injury or 
death from more than 15,000 types of consumer products, including some 
that may be manufactured with nanomaterials. 

The NNI is managed within the framework of the National Science and 
Technology Council's (NSTC) Committee on Technology. The NSTC is an 
organization through which the President coordinates science and 
technology policies across the federal government. The NSTC is managed 
by the Director of the Office of Science and Technology Policy (OSTP), 
who also serves as the Science Advisor to the President. The NSTC's 
Committee on Technology established the Nanoscale Science, Engineering, 
and Technology (NSET) subcommittee to coordinate communication between 
the federal government's multiagency nanoscale research and development 
programs. The NSET subcommittee is composed of representatives from any 
agencies that choose to participate in the NNI (as of January 2008, 25 
agencies are involved) and serves as the primary interagency 
coordination mechanism for nanotechnology-related research. Supporting 
the NSET subcommittee, the National Nanotechnology Coordinating Office 
(NNCO) provides day-to-day technical guidance and administrative 
assistance to prepare multiagency planning, budget, and assessment 
documents. In addition, the NSET subcommittee has established a number 
of working groups to help better focus interagency attention and 
activity on specific issues, such as the Nanotechnology Environmental 
and Health Implications (NEHI) working group. This group was designed 
to provide for exchange of information among participating agencies; 
facilitate the identification, prioritization, and implementation of 
research; and promote communication to other federal and nonfederal 
entities. The NEHI working group also coordinates U.S. participation in 
international activities, including the programs of the Organisation 
for Economic Co-operation and Development. Currently, NEHI membership 
consists of 16 research and regulatory agencies. See figure 2 for the 
NNI's structure. 

Figure 2: National Nanotechnology Initiative Structure: 

This figure is a flowchart showing national nanotechnology initiative 
structure. 

[See PDF for image] 

Source: NNI. 

[End of figure] 

Under the NNI, each agency funds research and development projects that 
support its own mission as well as the NNI's goals. While agencies 
share information on their nanotechnology-related research goals with 
the NSET subcommittee and NEHI working group, each agency retains 
control over its decisions on the specific projects to fund. While the 
NNI was designed to facilitate intergovernmental cooperation and 
identify goals and priorities for nanotechnology research, it is not a 
research program. It has no funding or authority to dictate the 
nanotechnology research agenda for participating agencies. 

The NNI used its fiscal year 2000 strategic plan and its subsequent 
updates to delineate a strategy to support long-term nanoscale research 
and development, among other things. A key component of the 2000 plan 
was the identification of nine specific research and development areas-
-known as "grand challenges"--that highlighted federal research on 
applications of nanotechnology with the potential to realize 
significant economic, governmental, and societal benefits.[Footnote 5] 
Examples of potential breakthroughs cited in this strategic plan 
included developing materials that are 10 times stronger, but 
significantly lighter, than steel to make vehicles lighter and more 
fuel efficient; improving the speed and efficiency of computer 
transistors and memory chips by factors of millions; and developing 
methods to detect cancerous tumors that are only a few cells in size 
using nanoengineered contrast agents. 

In 2004, the NNI updated its strategic plan and described its goals as 
well as the investment strategy by which those goals were to be 
achieved.[Footnote 6] Consistent with the 21st Century Nanotechnology 
Research and Development Act, the NNI established major subject 
categories of research and development investment, called program 
component areas (PCA), that cut across the interests and needs of the 
participating agencies.[Footnote 7] These seven areas replaced the nine 
grand challenges and other nanotechnology investment areas that the 
agencies had previously used to categorize their nanotechnology 
research. Six of the seven areas are focused on the discovery, 
development, and deployment of nanotechnology. The seventh, societal 
dimensions, consists of two subareas--research on environmental, 
health, and safety; and education and research on ethical, legal, and 
other societal aspects of nanotechnology. The EHS portion of the 
societal dimensions PCA accounted for over $37 million in fiscal year 
2006. See figure 3 for a break out of research funds used, by PCA. 

Figure 3: Nanotechnology Research Funding by Program Component Area, 
Fiscal Year 2006: 

This figure is a pie chart showing nanotechnology research funding by 
program component area, fiscal year 2006. 

Fundamental phenomena and processes: $455.9: 33%; 
Nanomanufacturing: $33.8: 3%%; 
Societal dimensions (education and ethical, legal, and other societal 
issues): $35.7: 3%; 
Societal dimensions (environmental, health, and safety R&D): $37.7: 3%; 
Instrumentation research, metrology and standards: $51.1: 4%; 
Major research facilities and instrumentation acquisition: $152.4: 11%; 
Nanomaterials: $319.6: 23%. 

[See PDF for image] 

Source: GAO analysis of NNI budget data. 

[End of figure]  

PCAs are intended to provide a means by which the NSET subcommittee, 
OSTP, the Office of Management and Budget (OMB), Congress, and others 
may be informed of the relative federal investment in these key areas. 
PCAs also provide a structure by which the agencies that fund research 
and development can better direct and coordinate their activities. In 
response to increased concerns about the potential EHS risks of 
nanotechnology, in fiscal year 2005, the NSET subcommittee and the 
agencies agreed to separately report their research funding for each of 
the two components of the societal dimensions PCA. The December 2007 
update of the NNI's strategic plan reaffirmed the program's goals, 
identified steps to accomplish those goals, and formally divided the 
societal dimensions PCA into two separate PCAs--"environment, health, 
and safety" and "education and societal dimensions." 

Beginning with the development of the fiscal year 2005 federal budget, 
agencies have worked with OMB to identify funding for nanoscale 
research that would be reflected in the NNI's annual Supplement to the 
President's Budget. Specifically, OMB issued guidance that consisted of 
a definition of nanoscale research and a notice that OMB would work 
with agencies to identify data for each of the PCAs. OMB analysts 
reviewed aggregated, rather than project-level, data on research 
funding for each PCA to help ensure consistent reporting across the 
agencies. Agencies also relied on definitions of the specific PCAs 
developed by the NSET subcommittee to determine the appropriate area in 
which to report research funding. Neither NSET nor OMB provided 
guidance on whether or how to apportion funding for a single research 
project to more than one PCA, if appropriate. However, representatives 
from both NSET and OMB stressed that the agencies were not to report 
each research dollar more than once. 

Almost 20 Percent of EHS Research Projects Were Not Primarily Focused 
on Studying the EHS Risks of Nanotechnology: 

Although the NNI reported that federal agencies in fiscal year 2006 
devoted $37.7 million--or about 3 percent of the total of all 
nanotechnology research funding--to research that primarily focused on 
studying the EHS risks of nanotechnology, we found that about 18 
percent of the EHS research reported by the NNI cannot actually be 
attributed to this purpose. This was largely due to a reporting 
structure that did not lend itself to categorizing particular types of 
projects and limited guidance provided to the agencies by the NNI on 
how to consistently report EHS research. In addition to research 
reported as being primarily focused on the EHS risks of nanotechnology, 
some agencies conduct research that is not reflected in the EHS totals 
provided by the NNI either because they are not considered federal 
research agencies or because the primary purpose of the research was 
not to study EHS risks. 

EHS Research Constituted about 3 Percent of Federal Nanotechnology 
Research Funding in Fiscal Year 2006: 

Overall, 3 percent--or $37.7 million--of the approximately $1.3 billion 
dedicated for nanotechnology research funding in fiscal year 2006 was 
reported as being devoted to studying the EHS risks of nanotechnology. 
Our review of data on agency funding for 119 projects that were 
underway in fiscal year 2006 largely confirmed the figures reported by 
the NNI. Specifically, all but one of the five individual agencies 
reported the same or greater funding to us than what the NNI reported 
for fiscal year 2006. EPA reported slightly less to us than it did to 
the NNI. Largely these discrepancies resulted from timing differences 
in the date the NNI needed the data and the date agency officials 
finalized their review of fiscal year spending. For example, NIOSH 
reported $470,000 more to us because it had not included funding for a 
few projects in its report to the NNI, according to agency officials. 
Other differences resulted from rounding. 

As would be expected, our review of the descriptive information on EHS 
projects found that those agencies with missions directly related to 
protecting the environment or human health and safety devoted a greater 
percentage of their nanotechnology research budgets to studying EHS 
risks. For example, in fiscal year 2006, NIOSH reported devoting 100 
percent of its fiscal year 2006 nanotechnology research funds to 
support 23 projects to study EHS risks. These projects focused 
primarily on worker safety and exposure, such as gathering data on 
workplace exposure to nanomaterials and evaluating the extent to which 
particle size affects the toxicity of inhaled nanomaterials. Similarly, 
EPA reported devoting 82 percent of its nanotechnology research budget 
to study EHS risks. This research included human health-focused 
projects to examine the toxicity of manufactured nanomaterials at the 
molecular and cellular level, as well as environmentally focused 
projects to evaluate how nanomaterials disperse and change under 
different environmental conditions and the extent to which 
nanomaterials accumulate in the bodies of various animal species. 

In contrast, we found that agencies with broader missions devoted a 
smaller portion of their nanotechnology research funds to study EHS 
issues. For example, NIST, an agency oriented toward measurement 
science and standards, dedicated 3 percent of its nanotechnology 
research budget to EHS risks in fiscal year 2006. The majority of its 
research funding focused on such PCAs as fundamental phenomena and 
processes; nanoscale devices and systems; and instrumentation research, 
metrology, and standards. Similarly, NSF dedicated 6 percent of its 
fiscal year 2006 nanotechnology research funds on research related to 
EHS risks as compared with 41 percent focused on fundamental phenomena 
and processes. 

In fiscal year 2008, funding for both EHS-related research and 
nanoscale research in general is projected to grow. Overall 
nanotechnology research is projected to increase in fiscal year 2008 to 
about $1.4 billion, or an increase of 20 percent over fiscal year 2005 
figures. Funding for EHS-related research is expected to increase to 
approximately $59 million, an increase of 68 percent over fiscal year 
2005 levels. As a result, EHS research would grow to about 4 percent of 
projected nanotechnology research in fiscal year 2008. 

Current Reporting Structure and Limited Guidance Contribute to 
Inaccurate Reporting of EHS Risk Research: 

About 18 percent of the total research dollars reported by the agencies 
as being primarily focused on the study of nanotechnology-related EHS 
risks in fiscal year 2006 cannot actually be attributed to this 
purpose. Specifically, our analysis found that 22 of the 119 projects 
funded by five federal agencies were not primarily related to studying 
EHS risks. These 22 projects accounted for about $7 million of the 
total that the NNI reported as supporting research primarily focused on 
EHS risks. Almost all of these projects--20 out of 22--were funded by 
NSF, with the two additional projects funded by NIOSH. See table 2 for 
our analysis of the nanotechnology research projects reported as being 
primarily focused on EHS risks. 

Table 2: GAO Analysis of the Number and Dollar Value of Nanotechnology 
Research Projects Reported by Selected Agencies as Being Primarily 
Focused on Environmental, Health, and Safety Risks, Fiscal Year 2006: 

(Dollars in millions). 

Agency: EPA; 
Projects reported by agencies as being primarily focused on EHS: 10; 
Projects reported by agencies as being primarily focused on EHS: $3.6; 
Projects determined by GAO to be primarily focused on EHS: Number: 10; 
Projects determined by GAO to be primarily focused on EHS: $3.6; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
0; 
Projects determined by GAO not to be primarily focused on EHS: $0. 

Agency: NIH; 
Projects reported by agencies as being primarily focused on EHS: 18; 
Projects reported by agencies as being primarily focused on EHS: $5.6; 
Projects determined by GAO to be primarily focused on EHS: Number: 18; 
Projects determined by GAO to be primarily focused on EHS: $5.6; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
0; 
Projects determined by GAO not to be primarily focused on EHS: $0. 

Agency: NIOSH; 
Projects reported by agencies as being primarily focused on EHS: 23; 
Projects reported by agencies as being primarily focused on EHS: $4.3; 
Projects determined by GAO to be primarily focused on EHS: Number: 21; 
Projects determined by GAO to be primarily focused on EHS: $4.2; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
2; 
Projects determined by GAO not to be primarily focused on EHS: $0.1. 

Agency: NIST; 
Projects reported by agencies as being primarily focused on EHS: 2; 
Projects reported by agencies as being primarily focused on EHS: $2.4; 
Projects determined by GAO to be primarily focused on EHS: Number: 2; 
Projects determined by GAO to be primarily focused on EHS: $2.4; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
0; 
Projects determined by GAO not to be primarily focused on EHS: $0. 

Agency: NSF; 
Projects reported by agencies as being primarily focused on EHS: 66; 
Projects reported by agencies as being primarily focused on EHS: $21.1; 
Projects determined by GAO to be primarily focused on EHS: Number: 46; 
Projects determined by GAO to be primarily focused on EHS: $14.7; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
20; 
Projects determined by GAO not to be primarily focused on EHS: $6.4. 

Total; 
Projects reported by agencies as being primarily focused on EHS: 119; 
Projects reported by agencies as being primarily focused on EHS: $37; 
Projects determined by GAO to be primarily focused on EHS: Number: 97; 
Projects determined by GAO to be primarily focused on EHS: $30.5; 
Projects determined by GAO not to be primarily focused on EHS: Number: 
22; 
Projects determined by GAO not to be primarily focused on EHS: $6.5. 

Source: GAO analysis of agency obligations data. 

[A] Figures differ slightly from those reported by the NNI in the 
Supplement to the President's FY2008 Budget due to rounding error or 
modifications made to the project-level data after they were reported 
by agencies to the NNI. 

[End of table] 

We found that the primary purpose of many of these 22 projects was to 
explore ways to use nanotechnology to remediate environmental damage or 
to identify environmental, chemical, or biological hazards. For 
example, a number of NSF projects explored the use of nanotechnology to 
improve water or gaseous filtration systems. In other cases, NSF-funded 
research was targeted toward developing nanotechnology-based 
applications to remediate soil or water contamination. In addition, 
many of the projects NSF reported as having a primary purpose to study 
EHS risks were part of its efforts to build a national research 
infrastructure capable of supporting a wide range of nanotechnology- 
related research. Specifically, NSF sponsors 16 Nanoscale Science and 
Engineering Centers, many of which devote a portion of their research 
efforts to EHS risk-related projects. In these cases, NSF apportioned a 
segment of the Center funding to the EHS category to account for this 
research. At NIOSH, both projects that we identified as not being 
primarily focused on studying EHS risks were focused on using 
nanotechnology to mitigate workplace risks, such as developing advanced 
sensors that incorporate nanotechnology to detect the presence of toxic 
gases in the workplace. 

We found that the miscategorization of these 22 projects resulted 
largely from a reporting structure for nanotechnology research that 
does not easily allow agencies to recognize projects that use 
nanotechnology to improve the environment or enhance the detection of 
environmental contaminants, and from the limited guidance available to 
the agencies on how to consistently report EHS research. From fiscal 
years 2001 to 2004, the NSET subcommittee categorized federal research 
and development activities into nine categories, known as "grand 
challenges," that included one focused on "nanoscale processes for 
environmental improvement." Agencies funded and researchers initiated 
work on many of these 22 projects under the grand challenges 
categorization scheme. Starting in fiscal year 2005, NSET adopted a new 
categorization scheme for agencies to report their nanotechnology 
research. The new scheme, which was based on PCAs, eliminated the 
environmental improvement applications research category. Instead, 
agencies were asked to fund and report research designed to address or 
understand the risks associated with nanotechnology, as part of the 
societal dimensions PCA. In essence, the new scheme shifted the focus 
from applications-oriented research to research focused on the EHS 
implications of nanotechnology. However, under the new scheme, agencies 
no longer had a way to categorize environmentally focused research that 
had been initiated. As a result, NSF and NIOSH characterized these 
projects as EHS focused for lack of a more closely related category to 
place them in, according to program managers. Furthermore, neither NSET 
nor OMB provided agencies guidance on to how to apportion the dollars 
for a single project to more than one program component area, when 
appropriate. This is especially significant for broad, multiphase 
research projects, such as NSF's support to develop networks of 
research facilities with the capability to address a range of 
nanotechnology-related topics. Of the five agencies we reviewed, only 
NSF apportioned funds for a single project to more than one PCA. 

Agencies Conduct Additional Research that Also Helps Advance Scientific 
Knowledge of Potential EHS Risks: 

In addition to research reported to the NNI as being primarily focused 
on the EHS risks of nanotechnology, some agencies conduct research that 
is not reflected in the EHS totals provided by the NNI either because 
they are not considered federal research agencies or because the 
primary purpose of the research was not to study EHS risks. For 
example, FDA, which does not have a specific research budget and does 
not generally track nanotechnology research spending, used a portion of 
its operating funds in fiscal years 2004 through 2007 to undertake 15 
research projects to evaluate the potential health risks of 
nanomaterials in the products that it regulates. One such project 
focused on sunscreens that contain nanosized particles of titanium 
dioxide to better understand their potential to be absorbed into the 
body through the skin. Another project is designed to study the 
toxicological and immunological responses to nanoparticles that may be 
used in therapeutic drugs. A fundamental understanding of potential 
risks will help FDA develop guidance and make future regulatory 
decisions regarding the manufacture and use of FDA-regulated products 
using these materials, according to program managers. 

In addition, as noted in the NNI's annual Supplement to the President's 
Budget, some agencies conduct research that results in information 
highly relevant to EHS risks but that was not primarily directed at 
understanding or addressing those risks and therefore is not captured 
in the EHS total. For example, NIH has research underway to develop 
drug delivery mechanisms that use nanotechnology. While the primary 
purpose of such research is to develop medical applications using 
nanotechnology, the research also provides information on how toxic the 
nanomaterials are, whether they accumulate in body tissues, and how 
they interact with the body at the cellular and molecular level. 
Agencies report funding data for such research in other PCAs, such as 
nanoscale devices and systems, rather than the EHS area. In addition, 
NIST conducts an array of nanotechnology research to accurately 
quantify the properties of nanomaterials and determine their size, 
shape, and chemical composition. This type of information is needed to 
understand and measure nanomaterials to ensure safe handling and 
protection against potential health or environmental hazards. However, 
NIST reports the funding data for such research under other PCAs such 
as instrumentation research, metrology, and standards. 

Processes to Identify and Prioritize Needed EHS Research Appear 
Reasonable and Are Ongoing but a Comprehensive Research Strategy Has 
Not Yet Been Developed: 

Ongoing agency and NEHI working group efforts to identify and 
prioritize needed research related to the potential EHS risks of 
nanotechnology appear reasonable but have not as yet resulted in a 
comprehensive research strategy to guide EHS research across agencies. 
We found that the EHS risk research undertaken in fiscal year 2006 
addressed a range of EHS topics, was generally consistent with both 
agency-and NEHI-identified research priorities, and focused on the 
priority needs within each category to varying degrees. 

Agencies Have Identified Their EHS Research Priorities: 

We determined that each agency's nanotechnology research priorities 
generally reflect its mission. For example, the priorities identified 
by FDA and CPSC are largely focused on the detection and safety of 
nanoparticles in the commercial products they regulate. On the other 
hand, EHS research priorities identified by NSF reflect its broader 
mission to advance science in general, and include a more diverse range 
of priorities, such as the safety and transport of nanomaterials in the 
environment, and the safety of nanomaterials in the workplace. 

All eight agencies in our review have processes in place to identify 
and prioritize the research they need related to the potential EHS 
risks of nanotechnology. Most agencies have developed task forces or 
designated individuals to specifically consider nanotechnology issues 
and identify priorities, although the scope and exact purpose of these 
activities differ by agency. EPA, for example, formed a Nanomaterial 
Research Strategy Team to craft a long-term, focused plan to guide all 
of the agency's nanotechnology research. The strategy, which identifies 
EPA's research priorities around four key themes and seven scientific 
questions, is based in part on the agency's 2007 "Nanotechnology White 
Paper" that described scientific issues the agency should consider to 
help ensure safe development of nanotechnology and to understand the 
potential risks. At other agencies, particularly those that have little 
or no funding for nanotechnology research, specific individuals 
throughout the agency have been tasked to identify and prioritize EHS 
research needs. For example, CPSC has assigned individual staff 
responsible for different aspects related to consumer product safety, 
such as health scientists, to monitor trends in the use of 
nanomaterials in such products, which helps inform the agency's 
nanotechnology research priorities. Once identified, agencies 
communicate their EHS research priorities to the public and to the 
research community in a variety of ways, including publication in 
agency documents that specifically address nanotechnology issues, 
agency strategic plans or budget documents, agency Web sites, and 
presentations at public conferences or workshops. 

NNI's Efforts to Prioritize Research Needs Are Ongoing: 

In addition to the efforts of individual agencies, the NSET 
subcommittee has engaged in an iterative prioritization process through 
its NEHI working group, although this process is not yet complete. 
First, in 2006, NEHI identified but did not prioritize five broad 
research categories and 75 more specific subcategories of needs where 
additional information was considered necessary to further evaluate the 
potential EHS risks of nanotechnology.[Footnote 8] The report 
identified these five general research categories as (1) 
Instrumentation, Metrology, and Analytical Methods; (2) Nanomaterials 
and Human Health; (3) Nanomaterials and the Environment; (4) Health and 
Environmental Exposure Assessment; and (5) Risk Management 
Methods.[Footnote 9] Second, following efforts to obtain public input 
on its 2006 report, NEHI released another report in August 
2007,[Footnote 10] in which it distilled the previous list of 75 
unprioritized specific research needs into a set of five prioritized 
needs for each of the five general research categories.[Footnote 11] 

The NEHI working group has used these initial steps to identify the 
gaps between the needs and priorities it has identified and the 
research that agencies have underway. According to agency and NNI 
officials, once this gap analysis is complete, NEHI will formulate a 
long-term, overarching EHS research strategy. According to the August 
2007 report, the proposed strategy will list NEHI's final research 
priorities, describe current federal EHS research, document the unmet 
needs, identify opportunities for interagency collaboration, and 
establish a process for periodic review. As envisioned, the EHS 
research strategy will serve as guidance for individual agencies as 
they develop their own research agendas and make funding decisions. 
NEHI plans to complete this overarching research strategy and issue a 
report in early 2008, according to NNI officials. 

Agencies' and the NNI's Prioritization Processes Appear Reasonable: 

Despite the fact that a comprehensive research strategy for EHS 
research has yet to be finalized, the prioritization processes taking 
place within individual agencies and the NNI appear so far to be 
reasonable. Numerous agency officials said their agency's EHS research 
priorities were generally reflected both in the NEHI working group's 
2006 research needs and 2007 research prioritization reports. Our 
comparison of agency nanotechnology priorities to the NNI's priorities 
corroborated their statements. Specifically, we found that all but one 
of the research priorities identified by individual agencies could be 
linked to one or more of the five general research categories. For 
example, OSHA's need for toxicity data and information related to 
exposure is reflected in the two general research categories of Health 
and Environmental Exposure Assessment and Nanomaterials and Human 
Health. According to agency officials, the alignment of agency 
priorities with the general research categories is particularly 
beneficial to the regulatory agencies, such as CPSC and OSHA, which do 
not conduct their own research, but rely instead on research agencies 
for data to inform their regulatory decisions. 

In addition, we found that the primary purposes of agency projects 
underway in fiscal year 2006 were generally consistent with both agency 
priorities and the NEHI working group's research categories. Of these 
97 projects, 43 were focused on Nanomaterials and Human Health, 
including all 18 of the projects funded by NIH. In addition, EPA, 
NIOSH, and NSF each undertook research for this general research 
category. EPA and NSF funded all 25 projects related to Nanomaterials 
and the Environment. These two general research categories accounted 
for 70 percent of all projects focused on EHS risks. Reflective of its 
relatively large EHS research budget and broad mission, NSF sponsored 
projects in each of the five general research categories. In contrast, 
all the research projects NIST sponsored were related to 
Instrumentation, Metrology, and Analytical Methods. 

Agency research addressed each of the five general research categories 
and focused on the priority needs within each category to varying 
degrees. With the exception of the Human Health category, for which all 
specific needs were considered a top priority, 43 percent of projects 
addressed the two highest-priority needs in each category and 37 
percent addressed the two lowest-priority needs. For example, 8 of the 
11 projects in the Instrumentation, Metrology, and Analytic Methods 
category focused on the highest-priority need to "develop methods to 
detect nanomaterials in biological matrices, the environment, and the 
workplace." In contrast, of the 25 projects related to Nanomaterials 
and the Environment, 3 addressed the highest-priority need in the 
category--"understand the effects of engineered nanomaterials in 
individuals of a species and the applicability of testing schemes to 
measure effects"--and 11 addressed the fourth-ranked priority-- 
"determine factors affecting the environmental transport of 
nanomaterials." Moreover, although the NEHI working group considered 
the five specific research priorities related to human health equally 
important, 19 of the 43 projects focused on a single priority-- 
"research to determine the mechanisms of interaction between 
nanomaterials and the body at the molecular, cellular, and tissular 
levels." See table 3 for a summary of projects by agency and specific 
NEHI research priority. 

Table 3: Research Primarily Focused on the Environmental, Health, and 
Safety Risks of Nanotechnology by Agency and Specific Nanotechnology 
Environmental and Health Implications Working Group Research Priority: 

Instrumentation, Metrology, and Analytical Methods; 
EPA: 0; 
NIH: 0; 
NIOSH: 1; 
NIST: 2; 
NSF: 8; 
Total: 11. 

Instrumentation, Metrology, and Analytical Methods: 1. Develop methods 
to detect nanomaterials in biological matrices, the environment, and 
the workplace; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: 1; 
NSF: 7; 
Total: 8. 

Instrumentation, Metrology, and Analytical Methods: 2. Understand how 
chemical and physical modifications affect the properties of 
nanomaterials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Instrumentation, Metrology, and Analytical Methods: 3. Develop methods 
for standardizing assessment of particle size, size distribution, 
shape, structure, and surface area; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 1; 
NIST: 1; 
NSF: [Empty]; 
Total: 2. 

Instrumentation, Metrology, and Analytical Methods: 4. Develop 
certified reference materials for chemical and physical 
characterization of nanomaterials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Instrumentation, Metrology, and Analytical Methods: 5. Develop methods 
to characterize a nanomaterial's spatio-chemical composition, purity, 
and heterogeneity; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 1; 
Total: 1. 

Nanomaterials and Human Health; 
EPA: 4; 
NIH: 18; 
NIOSH: 10; 
NIST: 0; 
NSF: 11; 
Total: 43. 

Nanomaterials and Human Health: 1. Develop methods to quantify and 
characterize exposure to nanomaterials and characterize nanomaterials 
in biological matrices[A]; 
EPA: 1; 
NIH: 1; 
NIOSH: 4; 
NIST: [Empty]; 
NSF: 2; 
Total: 8. 

Nanomaterials and Human Health: 2. Understand the absorption and 
transport of nanomaterials throughout the human body[A]; 
EPA: 1; 
NIH: 1; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 2; 
Total: 4. 

Nanomaterials and Human Health: 3. Establish the relationship between 
the properties of nanomaterials and uptake via the respiratory or 
digestive tracts or through the eyes or skin, and assess body 
burden[A]; 
EPA: [Empty]; 
NIH: 5; 
NIOSH: 3; 
NIST: [Empty]; 
NSF: 1; 
Total: 9. 

Nanomaterials and Human Health: 4. Determine the mechanisms of 
interaction between nanomaterials and the body at the molecular, 
cellular, and tissular levels[A]; 
EPA: 1; 
NIH: 10; 
NIOSH: 3; 
NIST: [Empty]; 
NSF: 5; 
Total: 19. 

Nanomaterials and Human Health: 5. Identify or develop appropriate in 
vitro and in vivo assays/ models to predict in vivo human responses to 
nanomaterials exposure[A]; 
EPA: 1; 
NIH: 1; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 1; 
Total: 3. 

Nanomaterials and the Environment; 
EPA: 5; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 20; 
Total: 25. 

Nanomaterials and the Environment: 1. Understand the effects of 
engineered nanomaterials in individuals of a species and the 
applicability of testing schemes to measure effects; 
EPA: 1; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 2; 
Total: 3. 

Nanomaterials and the Environment: 2. Understand environmental 
exposures through identification of principle sources of exposure and 
exposure routes; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 1; 
Total: 1. 

Nanomaterials and the Environment: 3. Evaluate abiotic and ecosystem-
wide effects; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 6; 
Total: 6. 

Nanomaterials and the Environment: 4. Determine factors affecting the 
environmental transport of nanomaterials; 
EPA: 2; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 9; 
Total: 11. 

Nanomaterials and the Environment: 5. Understand the transformation of 
nanomaterials under different environmental conditions; 
EPA: 2; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 2; 
Total: 4. 

Health and Environmental Exposure Assessment; 
EPA: 0; 
NIH: 0; 
NIOSH: 3; 
NIST: 0; 
NSF: 2; 
Total: 5. 

Health and Environmental Exposure Assessment: 1. Characterize exposures 
among workers; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 2; 
NIST: [Empty]; 
NSF: 1; 
Total: 3. 

Health and Environmental Exposure Assessment: 2. Identify population 
groups and environments exposed to engineered nanoscale materials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Health and Environmental Exposure Assessment: 3. Characterize exposure 
to the general population from industrial processes and industrial and 
consumer products containing nanomaterials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Health and Environmental Exposure Assessment: 4. Characterize health of 
exposed populations and environments; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Health and Environmental Exposure Assessment: 5. Understand workplace 
processes and factors that determine exposure to nanomaterials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 1; 
NIST: [Empty]; 
NSF: 1; 
Total: 2. 

Risk Management Methods; 
EPA: 1; 
NIH: 0; 
NIOSH: 7; 
NIST: 0; 
NSF: 5; 
Total: 13. 

Risk Management Methods: 1. Understand and develop best workplace 
practices, processes, and environmental exposure controls; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 4; 
NIST: [Empty]; 
NSF: 2; 
Total: 6. 

Risk Management Methods: 2. Examine product or material life cycle to 
inform risk reduction decisions; 
EPA: 1; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: 1; 
Total: 2. 

Risk Management Methods: 3. Develop risk characterization information 
to determine and classify nanomaterials based on physical or chemical 
properties; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 1; 
NIST: [Empty]; 
NSF: 2; 
Total: 3. 

Risk Management Methods: 4. Develop nanomaterial-use and safety-
incident trend information to help focus risk management efforts; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: [Empty]; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 0. 

Risk Management Methods: 5. Develop specific risk communication 
approaches and materials; 
EPA: [Empty]; 
NIH: [Empty]; 
NIOSH: 2; 
NIST: [Empty]; 
NSF: [Empty]; 
Total: 2. 

Total; 
EPA: 10; 
NIH: 18; 
NIOSH: 21; 
NIST: 2; 
NSF: 46; 
Total: 97. 

Source: GAO analysis of agency data. 

[A] Priorities given equal weight. 

[End of table] 

Despite the fact that the NEHI working group's priorities reflect 
individual agency priorities, some environmental and industry groups 
have called for a more top-down and directed approach to the NNI's 
prioritization efforts. In various congressional testimonies and in 
written comments on the NEHI working group's draft reports, some groups 
have suggested that the NNI adopt a stronger, more autonomous role in 
setting the federal EHS research agenda. Some of these groups suggest 
that the NNI should have the authority to direct participating agencies 
to undertake research in specific EHS areas, its own budget authority, 
and the ability to shift EHS research dollars among the agencies. 
Proponents believe that this more centralized approach would help 
ensure that a cohesive EHS research strategy is implemented in a timely 
manner and that sufficient resources are dedicated to the highest- 
priority research. 

However, such a strategy may not be consistent with historical 
approaches used to set federal research priorities and would be 
difficult to implement given how federal research currently is funded. 
Federal expenditures for research and development are regular budget 
items and are contained, along with other types of expenditures, within 
the budgets of more than 20 federal agencies. For some of these 
agencies, research is a major activity, and for others, it is a smaller 
part of a much larger set of programs. Centralizing nanotechnology 
research expenditures in a single existing agency or new agency would 
be difficult to achieve. In addition, agency officials we spoke with 
were generally satisfied with the current bottom-up, consensus-based 
approach. Moreover, they said the process has benefited from the in- 
depth expertise each agency has developed. For example, NIH played a 
large role in shaping the priorities for Nanomaterials and Human 
Health; NIST was heavily involved with Instrumentation, Metrology, and 
Analytical Methods; and NIOSH was a major contributor to the 
development of priorities for Health and Environmental Exposure 
Assessment. Some officials acknowledged that while the current approach 
has limitations, it benefits from the input of a broader range of 
stakeholders. According to one official, information bubbles up through 
the NNI structure and is utilized to inform and create a top-down 
vision, which then serves to guide agency funding decisions. 

Coordination Processes Have Fostered Interagency Collaboration and 
Information-Sharing: 

Agency and NNI processes to coordinate research and other activities 
related to the potential EHS risks of nanotechnology have been 
generally effective, and have resulted in numerous interagency 
collaborations. In fact, all eight agencies in this review have 
collaborated on multiple occasions with other NEHI-member agencies on 
activities related to the EHS risks of nanotechnology. These EHS- 
related activities are consistent with the expressed goals of the 
larger NNI--to promote the integration of federal efforts through 
communication, coordination, and collaboration. The NEHI working group 
is at the center of this effort. Regular NEHI working group meetings, 
augmented by informal discussions, have provided a venue for agencies 
to exchange information on a variety of topics associated with EHS 
risks, including their respective research needs and opportunities for 
collaborations. 

Interagency collaboration has taken many forms, including joint 
sponsorship of EHS-related research and workshops, the detailing of 
staff to other NEHI working group agencies, and various other general 
collaborations or memoranda of understanding. For example, FDA, NIST, 
and NIH's Nanotechnology Characterization Laboratory have initiated 
formal agreements to collaborate on research to characterize the 
physical and biological properties of nanomaterials used in cancer 
diagnosis and treatment.[Footnote 12] An FDA official said that this 
arrangement was developed primarily through discussions that occurred 
as a result of the agencies' participation in NEHI. Participation in 
NEHI has helped facilitate other types of interagency collaborations 
including a 2007 memorandum of understanding between EPA and NSF to 
create and fund research at a virtual Center for the Environmental 
Implications of Nanotechnology, detailing a CPSC toxicologist to a 
research laboratory office at EPA, and sponsoring international 
conferences on nanotechnology and occupational health by all NNI 
agencies, led by NIOSH, in 2005, 2006, and 2007. See table 4 for more 
examples of interagency collaboration. 

Table 4: Examples of Agency Collaborations Related to Potential EHS 
Risks of Nanotechnology: 

General Collaborations: * NIH's National Characterization Laboratory, 
in partnership with FDA and NIST, is developing characterization 
methods to evaluate nanomaterials intended for cancer treatments. 

General Collaborations: * EPA and NSF signed a memorandum of 
understanding to create and fund research at a virtual Center for the 
Environmental Implications of Nanotechnology. 

General Collaborations: * CPSC, FDA, NIH, and NIOSH have participated 
collaboratively on the Toxicological Evaluation of Nanoscale Materials 
program within the National Toxicology Program. 

General Collaborations: * NIOSH and OSHA have collaborated to develop 
guidelines for working with engineered nanomaterials. 

General Collaborations: * NIH and NIST have collaborated to 
characterize properties of nanoparticles commonly used in sunscreen 
lotions. 

General Collaborations: * Staff from NIST and CPSC have been detailed 
to other NNI agencies. 

Grant Solicitations: * EPA, NIH, NIOSH, and NSF have issued interagency 
competitive grant announcements through EPA's Science to Achieve 
Results program to address various environmental and health 
implications of nanotechnology. 

Grant Solicitations: * EPA, NIH, and NIOSH have developed an 
interagency Funding Opportunity Announcement to investigate the 
biocompatibility and toxicity of industrial nanomaterials in mammals. 

Grant Solicitations: * EPA and NIOSH have funded research on the 
dispersion of nanoscale particulate aerosols. 

Workshops: * NIOSH and other NNI agencies have sponsored international 
conferences on nanotechnology and occupational health in 2005, 2006, 
and 2007. 

Workshops: * NSF has facilitated meetings for NSF grantees on the EHS 
aspects of nanotechnology with participation from other NNI agencies. 

Source: GAO. 

[End of table] 

Furthermore, the NEHI working group has adopted a number of practices 
GAO has previously identified as essential to helping enhance and 
sustain collaboration among federal agencies.[Footnote 13] For example, 
NEHI's 2005 "Terms of Reference" clearly defined its purpose and 
objectives and delineated roles and responsibilities for group members. 
Furthermore, collaboration through multiagency grant announcements and 
jointly sponsored workshops has served as a mechanism to leverage 
limited resources to achieve increased knowledge about potential EHS 
risks. Despite the general effectiveness of its collaboration efforts, 
the NEHI working group has not yet completed an overarching strategy to 
help align the agencies' EHS research efforts. A completed strategy, 
combined with the results of the research needs prioritization process, 
also will serve as a means to monitor, evaluate, and report on the 
progress of meeting EHS research needs. In the meantime, the NNI's 
annual Supplements to the President's Budget have described the 
agencies' activities related to EHS issues, among other things, and 
provided a mechanism to reinforce agency accountability and 
performance. 

Finally, all agency officials we spoke with expressed satisfaction with 
their agency's participation in the NEHI working group, specifically, 
the coordination and collaboration on EHS risk research and other 
activities that have occurred as a result of their participation. Many 
officials described NEHI as unique among interagency efforts in terms 
of its effectiveness. Given limited resources, the development of 
ongoing relationships between agencies with different missions, but 
compatible nanotechnology research goals, is particularly important. 
NIH officials commented that their agency's collaboration with NIST to 
develop standard reference materials for nanoparticles may not have 
occurred as readily had it not been for regular NEHI meetings and 
workshops. In addition, NEHI has effectively brought together research 
and regulatory agencies, which has enhanced planning and coordination. 
Many officials noted that participation in NEHI has frequently given 
regulators the opportunity to become aware of and involved with 
research projects at a very early point in their development, which has 
resulted in research that better suits the needs of regulatory 
agencies. Participation in NEHI is particularly important for agencies 
like CPSC, FDA, and OSHA that do not have dedicated budgets for 
nanotechnology research. 

Many officials also cited the dedication of individual NEHI working 
group representatives, who participate in the working group in addition 
to their regular agency duties, as critical to the group's overall 
effectiveness. A number of the members has served on the body for 
several years, providing stability and continuity that contributes to a 
collegial and productive working atmosphere. In addition, because 
nanotechnology is relatively new with many unknowns, these officials 
said the agencies are excited about advancing knowledge about 
nanomaterials and contributing to the informational needs of both 
regulatory and research agencies. Furthermore, according to some 
officials, there is a shared sense among NEHI representatives of the 
need to apply lessons learned from the development of past 
technologies, such as genetically modified organisms, to help ensure 
the safe development and application of nanotechnology. 

Conclusions: 

Nanotechnology is likely to affect many aspects of our daily lives in 
the future as novel drug delivery systems, improved energy storage 
capabilities, and stronger, lightweight materials are developed and 
made available to the public. However, for a technology that may become 
ubiquitous, it is essential to consider the potential risks of using 
nanotechnology in concert with its potential benefits. The first steps 
are to identify what is not known about the properties of nanomaterials 
and what must be known about how these materials interact with our 
bodies and our environment. The NNI, through its NEHI working group, 
has begun a process to identify and prioritize both the research needed 
to better understand potential EHS risks and the gaps between what 
research is underway and the highest-priority needs. Essential to this 
process is consistent, accurate, and complete information on the amount 
of agency research designed to address and understand EHS risks. 
However, this information is not currently available because the totals 
reported by the NNI include research that is more closely related to 
uses of nanotechnology, rather than the risks nanotechnology may pose. 
Furthermore, agencies currently have limited guidance on how to report 
projects with more than one research focus across program component 
areas, when appropriate. As a result, the inventory of projects 
designed to address these risks is inaccurate and cannot ensure that 
agencies direct their future research investments appropriately. 

Recommendation for Executive Action: 

We recommend that the Director, OSTP, in consultation with the 
Director, NNCO, and the Director, OMB, provide better guidance to 
agencies regarding how to report research that has a primary focus to 
understand or address environmental, health, and safety risks of 
nanotechnology. 

Agency Comments and Our Evaluation: 

We provided CPSC, FDA, EPA, NIH, NIOSH, NIST, NSF, OSHA, and OSTP with 
a copy of this report for review and comment. OSTP generally concurred 
with the report's findings and agreed to review the manner in which 
agencies respond to the current guidance at future NSET meetings. In 
addition, the Department of Health and Human Services, on behalf of 
FDA, NIH, and NIOSH, said that the report clearly addressed the three 
charges that GAO was given and they provided technical comments which 
we incorporated as appropriate. In its comments, NIST said the report 
was fair and balanced. EPA, CPSC, NSF, and OSHA neither agreed nor 
disagreed with our report, and EPA and CPSC provided technical comments 
that we incorporated as appropriate. See appendices I, II, and III for 
agency comment letters from OSTP, HHS, and NIST, respectively. 

As agreed with your offices, 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 interested 
congressional committees and Members of Congress, the Secretary of 
Commerce, Secretary of Health and Human Services, the CPSC 
Commissioner, the EPA Administrator, the FDA Commissioner, the NIH 
Director, the NIOSH Director, the NIST Director, the NSF Director, the 
OSHA Administrator, and the OSTP Director. We will also make copies 
available to others upon request. In addition, the report will be 
available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staffs have questions about this report, please contact 
me at (202) 512-3841 or [email protected]. 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 key contributions to this 
report are listed in appendix IV. 

Signed by: 

Anu K. Mittal: 

Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Comments from the Office of Science and Technology Policy: 

Executive Office Of The President: 
Office Of Science And Technology Policy: 
Washington, D.C. 20502: 

March 3, 2008: 

Ms. Anu Mittal: 
Director of Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G. Street N.W.: 
Washington, D.C. 20548: 

Dear Ms. Mittal: 

Thank you for the opportunity to comment on the GAO's proposed report 
on Federally supported nanotechnology-related environmental, health, 
and safety research (GAO-08- 402). 

Generally, the Office of Science and Technology Policy (OSTP) agrees 
with the report's findings and is pleased that the GAO found 
interagency coordination and prioritization of nanotechnology EHS 
research to be effective and reasonable. OSTP is particularly pleased 
that the GAO noted one of the strengths of the government's interagency 
coordination lies in the knowledgeable and dedicated Federal employees 
that work in this area. 

With respect to GAO's finding that a fraction of NNI-identified EHS 
research projects is not primarily focused on EHS risks, OSTP 
acknowledges that this budget cross-cut is open to reasonable, 
different interpretations. These illustrate the challenges associated 
with attempting to categorize fundamental, knowledge-creating research 
and to determine to what degree such research is related to EHS. 
Nonetheless, while GAO's presumption in the process recommendationï¿½that 
more accurate reporting will better support program planning and policy 
developmentï¿½is correct in principle, it does not follow that marginal 
differences in individual agency reporting negatively affect 
interagency coordination and prioritization or agency-level 
implementation of nanotechnology EHS research. This is borne out by 
GAO's own findings in this report. 

OSTP, the Office of Management and Budget (OMB), and the National 
Nanotechnology Coordinating Office (NNCO) already provide extensive 
detailed guidance for reporting nanotechnology research, particularly 
for EHSï¿½more guidance, in fact, than perhaps any other area of 
Federally-funded research and development. This guidance is based 
directly on program component area designations established in the 
National Nanotechnology Initiative Strategic Plan by the interagency 
Subcommittee on Nanoscale Science, Engineering, and Technology (NSET) 
of the National Science and Technology Council. As with all agency 
reporting, we fundamentally rely on the expert judgment of the program 
managers at the agency level. 

In the aggregate, the data that are currently reported provide 
sufficient and clear perspective and are just one of many key inputs to 
guide coordination, program planning and future directions. Therefore, 
OSTP does not agree that more detailed reporting guidance will result 
in better coordination of nanotechnology EHS research. However, given 
the GAO's findings, OSTP will discuss the manner in which agencies 
respond to current guidance at future NSET meetings. 

Thank you for the opportunity to comment. OSTP appreciates GAO's 
efforts to fully understand the NNI and NSET interagency coordination 
process, and generally agrees with the report's overall assessments. 

Sincerely, 

Signed by: 

John H. Marburger, III: 
Director: 

[End of section] 

Appendix II Comments from the Department of Health and Human Services: 

Department Of Health & Human Services: 
Office of the Assistant Secretary for Legislation: 
Washington, D.C. 20201: 

February 29, 2008: 

Ms. Anu Mittal: 
Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
Washington, DC 20548: 

Dear Ms. Mittal: 

Enclosed are the Department's comments on the U.S. Government 
Accountability Office's (GAO) draft report entitled: Nanotechnology: 
Better Guidance Is Needed to Ensure Accurate Reporting of Federal 
Research Focused on Environmental, Health, and Safety Risks (GAO 08-
402). 

The Department appreciates the opportunity to review and comment on 
this draft report before its publication. 

Sincerely, 

Jennifer R. Luong: 

for: 

Vince Ventimiglia: 
Assistant Secretary for Legislation: 

General Comments Of The U.S. Department Of Health And Human Services 
(HHS) On The U.S. Government Accountability Office's Draft (GAO) Draft 
Report Entitled: "Nanotechnology: Better Guidance Is Needed To Ensure 
Accurate Reporting Of Federal Research Focused On Environmental, 
Health, And Safety Risks "(GAO-08-402): 

The report clearly addresses the three charges that GAO was given, but 
in finding that there were some misclassifications of "applications" 
projects as "implications," the report could have focused more on the 
adequacy of funding for research on environmental and occupational 
health and safety implications. Additionally, the report does not 
distinguish funding derived from NNI allocations and funding resulting 
if an agency reprograms non NNI internal funds. 

The report does not discuss the activities of OSHA regarding 
occupational health risks.

[End of section] 

Appendix III: Comments from the National Institute of Standards and 
Technology: 

United States Department Of Commerce: 
National Institute of Standards and Technology: 
Gaithersburg, Maryland 20899-0001: 

Office Of The Director: 

February 21, 2008: 

Memorandum For: Anu Mittal: 
Director, Natural Resources and Environment: 
Government Accountability Office: 

From: Signed by: James M. Turner, Ph.D.: 
Acting Director: 

Subject - Comments on Government Accountability Office (GAO) Draft 
Report Entitled "Nanotechnology: Better Guidance is Needed to Ensure 
Accurate Reporting of Federal Research Focused on Environmental, 
Health, and Safety Risks" (GAO-08-402): 

This is in response to your draft report dated March 2008 entitled 
"Nanotechnology: Better Guidance is Needed to Ensure Accurate Reporting 
of Federal Research Focused on Environmental, Health, and Safety 
Risks." Thank you for the opportunity to review and comment on this 
draft. 

Overall, the draft report is fair and balanced. The report does not, 
however, explicitly incorporate changes requested by the National 
Institute of Standards and Technology (NIST) to elucidate the 
relatively large size of nanotechnology Environmental Health and Safety 
(EHS) - enabling NIST research compared to the small size of explicitly 
nanotechnology EHS - focused Program Component Area (PCA) 7A research. 

The report accurately notes that "Some agencies conduct research that 
results in information highly relevant to EHS risks but that this 
research was not primarily directed at understanding, or addressing, 
those risks and therefore is not captured in the EHS total." Further, 
the report gives two detailed examples of research resulting in 
information highly relevant to EHS risks, and included NIST in these 
examples. I appreciate the recognition of this situation and agree with 
the findings. I am committed to ensuring that NIST continues to provide 
technically sound and timely standards support to the National 
Nanotechnology Initiative (NNI). 

We are looking forward to receiving your final report. Please contact 
Steve Willett on (301) 975-8707 should you have any questions regarding 
this response.

[End of section] 

Appendix IV: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Anu Mittal, 202-512-3841 or [email protected]: 

Staff Acknowledgments: 

In addition to the contact person named above, Cheryl Williams 
(Assistant Director), Nancy Crothers, Elizabeth Erdmann, David Lutter, 
and Rebecca Shea made key contributions to this report. 

[End of section] 

Footnotes: 

[1] The creation of the NNI formalized an existing interagency dialogue 
on nanotechnology that began in 1998. 

[2] For purposes of this report we use the term "research agency" to 
mean an agency whose primary mission is to conduct or facilitate 
scientific research, and the term "regulatory agency" to mean an agency 
whose primary mission is to administer regulatory programs related to 
environment, human health, and safety, and which may have a role in 
regulating products containing nanomaterials. A small number of 
agencies carry out both functions; we will refer to these by their 
primary mission. 

[3] As of December 2007, a total of four working groups exist within 
the NSET subcommittee: (1) Global Issues in Nanotechnology; (2) 
Nanotechnology Environmental and Health Implications; (3) 
Nanomanufacturing, Industry Liaison, and Innovation; and (4) 
Nanotechnology Public Engagement and Communications. 

[4] Pub. L. No. 108-153 (2003). 

[5] The nine grand challenges were as follows: nanostructured materials 
by design; manufacturing at the nanoscale; chemical-biological- 
radiological-explosive detection, and protection; nanoscale 
instrumentation and metrology; nano-electronics, -photonics, and - 
magnetics; healthcare, therapeutics, and diagnostics; efficient energy 
conversion and storage; microcraft and robotics; and nanoscale 
processes for environmental improvement. 

[6] The NNI's four goals are to (1) maintain a world-class research and 
development program aimed at realizing the full potential of 
nanotechnology; (2) facilitate transfer of new technologies into 
products for economic growth, jobs, and other public benefit; (3) 
develop educational resources, a skilled workforce, and the supporting 
infrastructure and tools to advance nanotechnology; and (4) support 
responsible development of nanotechnology. 

[7] The seven program component areas are fundamental nanoscale 
phenomena and processes; nanomaterials; nanoscale devices and systems; 
instrumentation research, metrology, and standards for nanotechnology; 
nanomanufacturing; major research facilities and instrumentation 
acquisition; and societal dimensions. 

[8] NSTC, Committee on Technology, Subcommittee on Nanoscale Science, 
Engineering, and Technology, "Environmental, Health, and Safety 
Research Needs for Engineered Nanoscale Materials," Sept. 20, 2006. 

[9] The Health and Environmental Exposure Assessment category was 
initially named Health and Environmental Surveillance. 

[10] NSTC, Committee on Technology, Subcommittee on Nanoscale Science, 
Engineering, and Technology, NEHI Working Group, "Prioritization of 
Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials: An Interim Document for Public Comment," Aug. 16, 
2007. 

[11] The five specific needs for the Nanomaterials and Human Health 
category were all afforded the same top priority. 

[12] The Nanotechnology Characterization Laboratory is part of NIH's 
National Cancer Institute. 

[13] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, GAO-06-15 
(Washington, D.C.: Oct. 21, 2005). 

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