Nanotechnology
Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved Gao ID: GAO-08-709T April 24, 2008In 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.
In fiscal year 2006, federal agencies devoted $37.7 million--or 3 percent of the $1.3 billion total nanotechnology research funding--to 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 GAO's 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 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.
GAO-08-709T, Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved
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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 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.
What GAO Found:
In fiscal year 2006, federal agencies devoted $37.7 million”or 3
percent of the $1.3 billion total nanotechnology research funding”to
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 GAO‘s 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
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.
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
mittala@gao.gov.
[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 mittala@gao.gov. 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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