Nanotechnology: Accuracy of Data on Federally Funded		 
Environmental, Health, and Safety Research Could Be Improved	 
(24-APR-08, GAO-08-709T).					 
                                                                 
In March 2008, GAO issued a report entitled Nanotechnology:	 
Better Guidance Is Needed to Ensure Accurate Reporting of Federal
Research Focused on Environmental, Health, and Safety Risks	 
(GAO-08-402). In this report, GAO reviewed the National 	 
Nanotechnology Initiative (NNI), a multiagency effort		 
administered by the Office of Science and Technology Policy	 
(OSTP). The NNI coordinates the nanotechnology-related activities
of 25 federal agencies that fund nanoscale research or have a	 
stake in the results. A key research area funded by some agencies
related to studying the potential environmental, health, and	 
safety (EHS) risks that may result from exposure to nanoscale	 
materials. For this testimony statement, GAO was asked to	 
summarize the findings of its March 2008 report, focusing on (1) 
the extent to which selected agencies conducted EHS research in  
fiscal year 2006; (2) the reasonableness of the agencies' and the
NNI's processes to identify and prioritize EHS research; and (3) 
the effectiveness of the agencies' and the NNI's process to	 
coordinate EHS research.					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-709T					        
    ACCNO:   A81863						        
  TITLE:     Nanotechnology: Accuracy of Data on Federally Funded     
Environmental, Health, and Safety Research Could Be Improved	 
     DATE:   04/24/2008 
  SUBJECT:   Data integrity					 
	     Environmental protection				 
	     Environmental research				 
	     Federal agencies					 
	     Federal funds					 
	     Funds management					 
	     Hazardous substances				 
	     Health hazards					 
	     Health research programs				 
	     Interagency relations				 
	     Materials research 				 
	     Product safety					 
	     Public health					 
	     Reporting requirements				 
	     Requirements definition				 
	     Research and development				 
	     Research and development costs			 
	     Research programs					 
	     Risk assessment					 
	     Risk factors					 
	     Risk management					 
	     Safety regulation					 
	     Safety standards					 
	     Strategic planning 				 
	     National Nanotechnology Initiative 		 

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GAO-08-709T

   

     * [1]Background
     * [2]Almost One-Fifth of Reported EHS Research Projects Were Not
     * [3]Processes to Identify and Prioritize Needed EHS Research App
     * [4]Coordination Processes Have Fostered Interagency Collaborati
     * [5]GAO Contact and Staff Acknowledgment

          * [6]Order by Mail or Phone


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Environmental, Health, and Safety Research Could Be Improved' which was 
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Testimony: 

Before the Subcommittee on Science, Technology, and Innovation, 
Committee on Commerce, Science, and Transportation, U.S. Senate: 

United States Government Accountability Office: 
GAO: 

For Release on Delivery: 
Expected at 2:30 p.m. EDT:
Thursday, April 24, 2008: 

Nanotechnology: 

Accuracy of Data on Federally Funded Environmental, Health, and Safety 
Research Could Be Improved: 

Statement of Robert A. Robinson: 
Managing Director: 
Natural Resources and Environment: 

GAO-08-709T: 

GAO Highlights: 

Highlights of GAO-08-709T, a testimony before the Subcommittee on 
Science, Technology, and Innovation, Committee on Commerce, Science, 
and Transportation, U.S. Senate. 

Why GAO Did This Study: 

In March 2008, GAO issued a report entitled Nanotechnology: Better 
Guidance Is Needed to Ensure Accurate Reporting of Federal Research 
Focused on Environmental, Health, and Safety Risks (GAO-08-402). In 
this report, GAO reviewed the National Nanotechnology Initiative (NNI), 
a multiagency effort administered by the Office of Science and 
Technology Policy (OSTP). The NNI coordinates the nanotechnology-
related activities of 25 federal agencies that fund nanoscale research 
or have a stake in the results. A key research area funded by some 
agencies related to studying the potential environmental, health, and 
safety (EHS) risks that may result from exposure to nanoscale 
materials. For this testimony statement, GAO was asked to summarize the 
findings of its March 2008 report, focusing on (1) the extent to which 
selected agencies conducted EHS research in fiscal year 2006; (2) the 
reasonableness of the agenciesï¿½ and the NNIï¿½s processes to identify and 
prioritize EHS research; and (3) the effectiveness of the agenciesï¿½ and 
the NNIï¿½s process to coordinate EHS research. 

What GAO Found: 

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, 
according to the NNI. 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 in fiscal year 2006 were not primarily 
related to understanding the extent to which nanotechnology may pose an 
EHS risk. Instead, many of these projects were focused on how to use 
nanotechnology to remediate environmental damage or detect hazards not 
related to nanotechnology. GAO determined that this mischaracterization 
is rooted in the current reporting structure that does not allow these 
types of projects to be easily categorized and the lack of guidance for 
agencies on how to apportion research funding across multiple topics, 
when appropriate. In addition to the EHS funding reported by the NNI, 
federal agencies conduct other research that is not captured in the EHS 
totals. This research was not captured by the NNI because either the 
research was funded by an agency not 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, at the time of GAOï¿½s review, were in the 
process of identifying and prioritizing EHS risk research needs and the 
overall process they were using appeared reasonable. For example, 
identification and prioritization of EHS research needs was being done 
by the agencies and the NNI collaboratively. The NNI also was engaged 
in an iterative prioritization effort through its Nanotechnology 
Environmental and Health Implications (NEHI) working group. Through 
this process, NEHI identified five general research categories as a 
priority for federally funded research. GAO found that most of the 
research projects that were underway in fiscal year 2006 were generally 
consistent with agency and NEHI priorities. NEHI released its new EHS 
research strategy on February 13, 2008. 

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. NEHI also has 
incorporated several practices that GAO has previously identified as 
key to enhancing and sustaining interagency collaborative efforts, such 
as defining a common outcome and leveraging resources. Finally, all 
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. 
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. 

What GAO Recommends: 

In its March 2008 report, GAO recommended better guidance to improve 
the accuracy of data reported by the NNI. Although OSTP asserted that 
it provides extensive guidance, it agreed to review how the agencies 
respond to the current guidance. GAO is making no new recommendations 
in this statement. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-709T]. For more 
information, contact Ms. Anu Mittal at (202) 512-3841 or 
[email protected]. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to participate in your hearing on the 
future direction of the National Nanotechnology Initiative (NNI). As 
you know, the NNI was established in 2001 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. One of the key roles of the NNI is to coordinate the 
nanotechnology-related activities of 25 federal agencies. These 
agencies include both those that fund nanoscale research as well as 
those that have a stake in the outcome of this research, such as 
agencies that regulate products containing nanomaterials. While the NNI 
is 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 or to ensure that adequate 
resources are available to achieve specific goals. Instead, 
participating agencies develop and fund their own nanotechnology 
research agendas, and in fiscal year 2006, 13 of the 25 agencies 
participating in the NNI allocated a total of about $1.3 billion from 
their appropriated budgets to nanotechnology research and development 
activities. Of this total in fiscal year 2006, the NNI reported that 
$37.7 million (or about 3 percent of the total) was used to fund 
research to study the potential environmental, health, and safety (EHS) 
risks that might result from exposure during the manufacture, use, and 
disposal or recycle of nanoscale materials. As you know, while the use 
of nanoscale materials holds much promise, the small size and unique 
properties of these materials raise questions about their potential EHS 
risks, and research is needed to fill current gaps in scientific 
information about their risks. 

At the request of the full committee and members of the Congressional 
Nanotechnology Caucus, we just completed a report that is being 
released today on the NNI's and federal agencies' efforts to study the 
potential environmental, health, and safety risks of 
nanotechnology.[Footnote 1] My testimony is based on the findings of 
this review and will cover the following three areas: (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. For our review, we collected data from five federal agencies 
that provided 96 percent of fiscal year 2006 funding for EHS research-
-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). We also contacted three 
regulatory agencies--the U.S. Consumer Product Safety Commission 
(CPSC), the Food and Drug Administration (FDA), and the Occupational 
Safety and Health Administration (OSHA)--that do not have specific 
research budgets to determine whether they conducted any research on 
their own relative to potential EHS risks. 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 finding 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. 

In summary we found the following: 

* About 20 percent of the over $37 million in fiscal year 2006 research 
expenditures that the NNI reported as being primarily focused on the 
EHS risks of nanotechnology cannot actually be attributed to this 
purpose. We found that 22 of the 119 projects identified as EHS-related 
by EPA, NIH, NIOSH, NIST, and NSF in fiscal year 2006 were not 
primarily related to understanding the extent to which nanotechnology 
poses an EHS risk. 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. 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 unrelated to 
nanotechnology. We determined that this mischaracterization was the 
result of the current reporting structure that does not allow these 
types of projects to be easily categorized in another more appropriate 
category, and also the lack of guidance for agencies on how to 
apportion research funding across multiple topics, when appropriate. To 
address this issue, we recommended that the Office of Science and 
Technology Policy (OSTP), in consultation with the NNI and the Office 
of Management and Budget (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 asserted that it already provides 
extensive guidance, but it agreed to review the manner in which 
agencies respond to the current guidance. 

* In addition to the EHS funding totals reported by the NNI, we found 
that federal agencies conduct other EHS research that is not captured 
in the NNI 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. Because the agencies that conduct this research 
do not systematically track it as EHS-related research, we could not 
establish the exact amount of federal funding that is being devoted to 
this additional EHS research. 

* Federal agencies and the NNI were, at the time of our review, in the 
process of identifying and prioritizing EHS risk research needs; 
overall, we believe that the process they were using was reasonable. 
For example, identification and prioritization of EHS research needs 
was being done by the agencies and the NNI collaboratively. The NNI was 
also engaged in an iterative prioritization effort through its 
Nanotechnology Environmental and Health Implications (NEHI) working 
group. As a result of this effort, NEHI had identified five general 
research categories that should be the focus of federal research 
efforts and five specific research priorities under each general 
category. 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 as well as NEHI's five general research categories. 
However, we did find that, while agency funded research addressed each 
of the five general research categories, it focused on the priority 
needs within each category to varying degrees. As our report was in 
production, NEHI released a new EHS research strategy on February 13, 
2008, which is intended to provide a framework to help ensure that the 
highest priority EHS research 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. 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 it had not, at the time of our review, 
completed its overarching strategy to help better align agencies' EHS 
research efforts. Finally, all agency officials we 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 group's effectiveness, including the 
stability of the working group membership and the expertise and 
dedication 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 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. To illustrate, a sheet of paper 
is about 100,000 nanometers thick and a human hair is about 80,000 
nanometers wide. At the nanoscale level, materials may exhibit 
electrical, biological, and other properties that differ significantly 
from the properties the same materials exhibit at a larger scale. 
Exploiting these differences in nanoscale materials 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. One research institute estimates that over 
500 consumer products already available to consumers may contain 
nanoscale materials. 

The National Nanotechnology Initiative (NNI) was established in 2001 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. Management of the NNI falls under the 
purview of the National Science and Technology Council (NSTC) that 
coordinates science and technology policy 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 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 2] 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. Similar to 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 legislation to establish a National 
Nanotechnology Program to coordinate federal nanotechnology research 
and development.[Footnote 3] 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. Six of the seven focus 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. 

As part of the annual federal budget process, agencies also report 
their research funding for each area to OMB. The 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 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 nanotechnology. Eight of the 13 
agencies that funded nanotechnology research in fiscal year 2006 
reported having devoted some of those resources to research that had a 
primary focus on potential EHS risks. 

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. 

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. Consistent with the 21st Century Nanotechnology Research and 
Development Act, the NNI reorganized its major subject categories of 
research and development investment into program component areas (PCA) 
that cut across the interests and needs of the participating agencies. 
These seven areas replaced the nine grand challenges that the agencies 
had used to categorize their nanotechnology research. Six of the areas 
focus on the discovery, development, and deployment of nanotechnology. 
The seventh, societal dimensions, consists of two topics--research on 
environmental, health, and safety; and education and research on 
ethical, legal, and other societal aspects of nanotechnology. 

PCAs are intended to provide a means by which the NSET subcommittee, 
OSTP, 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 can better direct and coordinate their 
activities. In response to increased concerns about the potential EHS 
risks of nanotechnology, the NSET subcommittee and the agencies agreed 
in fiscal year 2005 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 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. 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 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 One-Fifth of Reported EHS Research Projects Were Not Primarily 
Focused on Studying the EHS Risks of Nanotechnology: 

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, we 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. 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 not related to 
nanotechnology. For example, some NSF-funded research explored the use 
of nanotechnology to improve water or gaseous filtration systems. Table 
1 shows our analysis of the nanotechnology research projects reported 
as being primarily focused on EHS risks. 

Table 1: 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): 

Projects reported by agencies as being primarily focused on EHS: 

Agency: EPA; 
Number: 10; 
Dollar value[A]: $3.6. 

Agency: NIH; 
Number: 18; 
Dollar value[A]: $5.6. 

Agency: NIOSH; 
Number: 23; 
Dollar value[A]: $4.3. 

Agency: NIST; 
Number: 2; 
Dollar value[A]: $2.4. 

Agency: NSF; 
Number: 66; 
Dollar value[A]: $21.1. 

Agency: Total; 
Number: 119; 
Dollar value[A]: $37. 

Projects determined by GAO to be primarily focused on EHS: 

Agency: EPA; 
Number: 10; 
Dollar value[A]: $3.6. 

Agency: NIH; 
Number: 18; 
Dollar value[A]: $5.6. 

Agency: NIOSH; 
Number: 21; 
Dollar value[A]: $44.2. 

Agency: NIST; 
Number: 2; 
Dollar value[A]: $2.4. 

Agency: NSF; 
Number: 46; 
Dollar value[A]: $14.7. 

Agency: Total; 
Number: 97; 
Dollar value[A]: $30.5. 

Projects determined by GAO to be primarily focused on EHS: 

Agency: EPA; 
Number: 0; 
Dollar value[A]: $0. 

Agency: NIH; 
Number: 0; 
Dollar value[A]: $0. 

Agency: NIOSH; 
Number: 2; 
Dollar value[A]: $0.1. 

Agency: NIST; 
Number: 0; 
Dollar value[A]: $0. 

Agency: NSF; 
Number: 20; 
Dollar value[A]: $6.4. 

Agency: Total; 
Number: 22; 
Dollar value[A]: $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 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 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, based on 
PCAs, for agencies to report their nanotechnology research. The new 
scheme eliminated the research category of environmental improvement 
applications and asked agencies to report research designed to address 
or understand the risks associated with nanotechnology as part of the 
societal dimensions PCA. 

The new scheme shifted the focus from applications-oriented research to 
research focused on the EHS implications of nanotechnology. However, 
the new scheme had no way for agencies to categorize environmentally 
focused research that was underway. 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 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. Of the five agencies we reviewed, only 
NSF apportioned funds for a single project to more than one PCA. 

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, 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. This type of research provides information that is 
needed to understand and measure nanomaterials to ensure safe handling 
and protection against potential health or environmental hazards; 
however, such research is captured under other PCAs, such as 
instrumentation, metrology, and standards. Because the agencies that 
conduct this research do not systematically track it as EHS-related, we 
could not establish the exact amount of federal funding that is being 
devoted to this additional EHS research. 

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

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. 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. We determined that 
each agency's nanotechnology research priorities generally reflected 
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. 

In addition to the efforts of individual agencies, the NSET 
subcommittee has engaged in an iterative prioritization process through 
its NEHI working group. Beginning 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. NEHI obtained public input on its 2006 report and 
released another report in August 2007, 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. 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. NEHI issued a report 
summarizing the results of this analysis in February 2008. 

Although a comprehensive research strategy for EHS research had not 
been finalized at the time of our review, the prioritization processes 
taking place within individual agencies and the NNI appeared 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 these 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. 
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. 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. 

Furthermore, we determined that, while agency-funded research addressed 
each of the five general research categories, it focused on the 
priority needs within each category to varying degrees. Specifically, 
we found that the two highest-priority needs in each category were 
addressed only slightly more frequently than the two lowest-priority 
needs. 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." Table 2 shows a 
summary of projects by agency and specific NEHI research priority. 

Table 2: 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: 0; 
NIH: 0; 
NIOSH: 0; 
NIST: 1; 
NSF: 7; 
Total: 8. 

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

Instrumentation, Metrology, and Analytical Methods: 3. Develop methods 
for standardizing assessment of particle size, size distribution, 
shape, structure, and surface area; 
EPA: 0; 
NIH: 0; 
NIOSH: 1; 
NIST: 1; 
NSF: 0; 
Total: 2. 

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

Instrumentation, Metrology, and Analytical Methods: 5. Develop methods 
to characterize a nanomaterial's spatio-chemical composition, purity, 
and heterogeneity; 
EPA: 0; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
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: 0; 
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: 0; 
NIST: 0; 
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: 0; 
NIH: 5; 
NIOSH: 3; 
NIST: 0; 
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: 0; 
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: 0; 
NIST: 0; 
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: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 2; 
Total: 3. 

Nanomaterials and the Environment: 2. Understand environmental 
exposures through identification of principle sources of exposure and 
exposure routes; 
EPA: 0; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 1; 
Total: 1. 

Nanomaterials and the Environment: 3. Evaluate abiotic and ecosystem-
wide effects; 
EPA: 0; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 6; 
Total: 6. 

Nanomaterials and the Environment: 4. Determine factors affecting the 
environmental transport of nanomaterials; 
EPA: 2; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 9; 
Total: 11. 

Nanomaterials and the Environment: 5. Understand the transformation of 
nanomaterials under different environmental conditions; 
EPA: 2; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
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: 0; 
NIH: 0; 
NIOSH: 2; 
NIST: 0; 
NSF: 1; 
Total: 3. 

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

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

Health and Environmental Exposure Assessment: 5. Understand workplace 
processes and factors that determine exposure to nanomaterials; 
EPA: 0; 
NIH: 0; 
NIOSH: 1; 
NIST: 0; 
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: 0; 
NIH: 0; 
NIOSH: 4; 
NIST: 0; 
NSF: 2; 
Total: 6. 

Risk Management Methods: 2. Examine product or material life cycle to 
inform risk reduction decisions; 
EPA: 1; 
NIH: 0; 
NIOSH: 0; 
NIST: 0; 
NSF: 1; 
Total: 2. 

Risk Management Methods: 3. Develop risk characterization information 
to determine and classify nanomaterials based on physical or chemical 
properties; 
EPA: 0; 
NIH: 0; 
NIOSH: 1; 
NIST: 0; 
NSF: 2; 
Total: 3. 

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

Risk Management Methods: 5. Develop specific risk communication 
approaches and materials; 
EPA: 0; 
NIH: 0; 
NIOSH: 2; 
NIST: 0; 
NSF: 0; 
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] 

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. All eight agencies in our 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. 

We found that 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. 

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 4] For example, 
in 2005 NEHI 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. 

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. 

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 have 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. 

In closing, Mr. Chairman, while nanotechnology is likely to affect many 
aspects of our daily lives in the future as novel drug delivery 
systems, improved energy storage capability, and stronger, lightweight 
materials are developed and made available, it is essential to consider 
the potential risks of this technology in concert with its potential 
benefits. Federal funding for studying the potential EHS risks of 
nanotechnology is critical to enhancing our understanding of these new 
materials, and we must have consistent, accurate, and complete 
information on the amount of agency funding that is being dedicated to 
this effort. However, this information is not currently available 
because the totals reported by the NNI include research that is more 
focused on uses for nanotechnology, rather than the risks it 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 
the highest-priority research needs are met. 

Mr. Chairman, this concludes my prepared statement. I would be happy to 
respond to any questions that you and other Members may have. 

GAO Contact and Staff Acknowledgment: 

Contact points for our Offices of Congressional Relations and Public 
Affairs may be found on the last page of this testimony. For further 
information about this testimony, please contact Ms. Anu Mittal, at 
(202) 512-3841 or at [email protected]. Individuals who contributed to 
this statement include Nancy Crothers, Elizabeth Erdmann, David Lutter, 
Rebecca Shea, and Cheryl Williams. 

[End of section] 

Footnotes: 

[1] GAO, Nanotechnology: Better Guidance Is Needed to Ensure Accurate 
Reporting of Federal Research Focused on Environmental, Health, and 
Safety Risks, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-402] 
(Washington, D.C.: Mar. 31, 2008). 

[2] 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. 

[3] The 21st Century Nanotechnology Research and Development Act, Pub. 
L. 108-153 (2003). 

[4] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-06-15] (Washington, D.C.: Oct. 
21, 2005). 

[End of section] 

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