Nanotechnology
Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks Gao ID: GAO-08-402 March 31, 2008The National Nanotechnology Initiative (NNI), administered by the Office of Science and Technology Policy (OSTP), is a multiagency effort intended to coordinate the nanotechnology-related activities of 25 federal agencies that fund nanoscale research or have a stake in the results. Nanotechnology is the ability to control matter at the scale of a nanometer--one billionth of a meter. A key research area funded by some federal agencies relates to potential environmental, health, and safety (EHS) risks that may result from exposure to nanoscale materials. Because of concerns about federal efforts to fund and prioritize EHS research, GAO was asked to determine (1) the extent to which selected agencies conducted such research in fiscal year 2006; (2) the reasonableness of the agencies' and the NNI's processes to identify and prioritize such federal research; and (3) the effectiveness of the agencies' and the NNI's process to coordinate this research. GAO reviewed quantitative and qualitative data from five federal agencies that provided 96 percent of fiscal year 2006 funding for EHS research.
The NNI reported that in fiscal year 2006,federal agencies devoted $37.7million--or 3 percent of the $1.3 billion total nanotechnology research funding--to research that was primarily focused on the EHS risks of nanotechnology. However, about 20 percent of this total cannot actually be attributed to this purpose; GAO found that 22 of the 119 projects identified as EHS-related by five federal agencies in fiscal year 2006 were not focused on determining the extent to which nanotechnology poses an EHS risk. Instead, the focus of many of these projects was to explore how nanotechnology could be used to remediate environmental damage or to detect a variety of hazards. GAO determined that this mischaracterization is rooted in the current reporting structure which does not allow these types of projects to be easily categorized and the lack of guidance for agencies on how to apportion funding across multiple topics. In addition to the EHS funding totals reported by the NNI, federal agencies conduct other research that is not captured in the totals. This research was not captured by the NNI because either the research was funded by an agency not generally considered to be a research agency or because the primary purpose of the research was not to study EHS risks. Federal agencies and the NNI are currently in the process of identifying and prioritizing EHS risk research needs; the process they are using appears reasonable overall. For example, identification and prioritization of EHS research needs is being done by the agencies and the NNI. The NNI also is engaged in an iterative prioritization effort through its Nanotechnology Environmental and Health Implications (NEHI) working group. NEHI has identified five specific research priorities for five general research categories, but it has not yet completed the final steps of this process, which will identify EHS research gaps, determine specific research needed to fill those gaps, and outline a long-term, overarching EHS research strategy. GAO found that the focus of most EHS research projects underway in fiscal year 2006 was generally consistent with agency priorities and NEHI research categories and that the projects focused on the priority needs within each category to varying degrees. The anticipated EHS research strategy is expected to provide a framework to help ensure that the highest priority needs are met. Agency and NNI processes to coordinate activities related to potential EHS risks of nanotechnology have been generally effective. The NEHI working group has convened frequent meetings that have helped agencies identify opportunities to collaborate on EHS risk issues, such as joint sponsorship of research and workshops to advance knowledge and facilitate information-sharing among the agencies. In addition, NEHI has incorporated several practices that are key to enhancing and sustaining interagency collaboration, such as leveraging resources. Finally, agency officials GAO spoke with expressed satisfaction with the coordination and collaboration on EHS risk research that has occurred through NEHI. They cited several factors they believe contribute to the group's effectiveness, including the stability of the working group membership and the expertise and dedication of its members.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-08-402, Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
March 2008:
Nanotechnology:
Better Guidance Is Needed to Ensure Accurate Reporting of Federal
Research Focused on Environmental, Health, and Safety Risks:
Nanotechnology:
GAO-08-402:
GAO Highlights:
Highlights of GAO-08-402, a report to congressional requesters.
Why GAO Did This Study:
The National Nanotechnology Initiative (NNI), administered by the
Office of Science and Technology Policy (OSTP), is a multiagency effort
intended to coordinate the nanotechnology-related activities of 25
federal agencies that fund nanoscale research or have a stake in the
results. Nanotechnology is the ability to control matter at the scale
of a nanometer”one billionth of a meter. A key research area funded by
some federal agencies relates to potential environmental, health, and
safety (EHS) risks that may result from exposure to nanoscale
materials. Because of concerns about federal efforts to fund and
prioritize EHS research, GAO was asked to determine (1) the extent to
which selected agencies conducted such research in fiscal year 2006;
(2) the reasonableness of the agencies‘ and the NNI‘s processes to
identify and prioritize such federal research; and (3) the
effectiveness of the agencies‘ and the NNI‘s process to coordinate this
research. GAO reviewed quantitative and qualitative data from five
federal agencies that provided 96 percent of fiscal year 2006 funding
for EHS research.
What GAO Found:
The NNI reported that 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. However, about 20 percent of this total cannot
actually be attributed to this purpose; GAO found that 22 of the 119
projects identified as EHS-related by five federal agencies in fiscal
year 2006 were not focused on determining the extent to which
nanotechnology poses an EHS risk. Instead, the focus of many of these
projects was to explore how nanotechnology could be used to remediate
environmental damage or to detect a variety of hazards. GAO determined
that this mischaracterization is rooted in the current reporting
structure which does not allow these types of projects to be easily
categorized and the lack of guidance for agencies on how to apportion
funding across multiple topics. In addition to the EHS funding totals
reported by the NNI, federal agencies conduct other research that is
not captured in the totals. This research was not captured by the NNI
because either the research was funded by an agency not generally
considered to be a research agency or because the primary purpose of
the research was not to study EHS risks.
Federal agencies and the NNI are currently in the process of
identifying and prioritizing EHS risk research needs; the process they
are using appears reasonable overall. For example, identification and
prioritization of EHS research needs is being done by the agencies and
the NNI. The NNI also is engaged in an iterative prioritization effort
through its Nanotechnology Environmental and Health Implications (NEHI)
working group. NEHI has identified five specific research priorities
for five general research categories, but it has not yet completed the
final steps of this process, which will identify EHS research gaps,
determine specific research needed to fill those gaps, and outline a
long-term, overarching EHS research strategy. GAO found that the focus
of most EHS research projects underway in fiscal year 2006 was
generally consistent with agency priorities and NEHI research
categories and that the projects focused on the priority needs within
each category to varying degrees. The anticipated EHS research strategy
is expected to provide a framework to help ensure that the highest
priority needs are met.
Agency and NNI processes to coordinate activities related to potential
EHS risks of nanotechnology have been generally effective. The NEHI
working group has convened frequent meetings that have helped agencies
identify opportunities to collaborate on EHS risk issues, such as joint
sponsorship of research and workshops to advance knowledge and
facilitate information-sharing among the agencies. In addition, NEHI
has incorporated several practices that are key to enhancing and
sustaining interagency collaboration, such as leveraging resources.
Finally, agency officials GAO spoke with expressed satisfaction with
the coordination and collaboration on EHS risk research that has
occurred through NEHI. They cited several factors they believe
contribute to the group‘s effectiveness, including the stability of the
working group membership and the expertise and dedication of its
members.
What GAO Recommends:
GAO is recommending that OSTP provide better guidance to agencies
regarding how to report research that is primarily focused on EHS
risks. In commenting on a draft of this report, OSTP generally agreed
with the findings and will review the manner in which agencies respond
to current guidance.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-402]. For more
information, contact Anu Mittal at (202) 512-3841 or mittala@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Almost 20 Percent of EHS Research Projects Were Not Primarily Focused
on Studying the EHS Risks of Nanotechnology:
Processes to Identify and Prioritize Needed EHS Research Appear
Reasonable and Are Ongoing but a Comprehensive Research Strategy Has
Not Yet Been Developed:
Coordination Processes Have Fostered Interagency Collaboration and
Information-Sharing:
Conclusions:
Recommendation for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Comments from the Office of Science and Technology Policy:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: Comments from the National Institute of Standards and
Technology:
Appendix IV: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Federal Agencies Participating in the National Nanotechnology
Initiative, as of December 2007:
Table 2: GAO Analysis of the Number and Dollar Value of Nanotechnology
Research Projects Reported by Selected Agencies as Being Primarily
Focused on Environmental, Health, and Safety Risks, Fiscal Year 2006:
Table 3: Research Primarily Focused on the Environmental, Health, and
Safety Risks of Nanotechnology by Agency and Specific Nanotechnology
Environmental and Health Implications Working Group Research Priority:
Table 4: Examples of Agency Collaborations Related to Potential EHS
Risks of Nanotechnology:
Figures:
Figure 1: Nanotechnology EHS Research by Agency, as Reported by the
National Nanotechnology Initiative, Fiscal Year 2006:
Figure 2: National Nanotechnology Initiative Structure:
Figure 3: Nanotechnology Research Funding by Program Component Area,
Fiscal Year 2006:
Abbreviations:
CPS: CU.S. Consumer Product Safety Commission:
EHS: environmental, health, and safety:
EPA: Environmental Protection Agency:
FDA: Food and Drug Administration:
HHS: Department of Health and Human Services:
NEHI: Nanotechnology Environmental and Health Implications (working
group):
NIH: National Institutes of Health:
NIOSH: National Institute for Occupational Safety and Health:
NIST: National Institute of Standards and Technology:
NNCO: National Nanotechnology Coordinating Office:
NNI: National Nanotechnology Initiative:
NSET: Nanoscale Science, Engineering, and Technology (subcommittee):
NSF: National Science Foundation:
NSTC: National Science and Technology Council:
OMB: Office of Management and Budget:
OSHA: Occupational Safety and Health Administration:
OSTP: Office of Science and Technology Policy:
PCA: program component area:
United States Government Accountability Office:
Washington, DC 20548:
March 31, 2008:
The Honorable Daniel K. Inouye:
Chairman:
The Honorable Mark L. Pryor:
The Honorable Gordon H. Smith:
Committee on Commerce, Science, and Transportation:
United States Senate:
The Honorable Ron Wyden:
The Honorable Richard Burr:
Congressional Nanotechnology Caucus:
United States Senate:
Nanotechnology encompasses a wide range of innovations based on the
understanding and control of matter at the scale of nanometers--the
equivalent of one-billionth of a meter. For illustration, a sheet of
paper is about 100,000 nanometers thick, a human hair is about 80,000
nanometers wide, and 2 gold atoms lying side by side are about 1
nanometer long. At the nanoscale level, some materials may exhibit
electrical, magnetic, biological, and other properties that differ
significantly from properties the same materials exhibit at a larger
scale. For example, opaque materials, such as copper, become
transparent at the nanoscale and inert materials, such as platinum and
gold, become chemical catalysts. Exploiting the differences in the size
and properties of materials at the nanoscale level has led to a range
of commercial uses and holds the promise for innovations in virtually
every industry from aerospace and energy to health care and
agriculture. In 2006, an estimated $50 billion in products worldwide
incorporated nanotechnology and this figure has been projected to grow
to $2.6 trillion by 2014, according to an industry analyst. The Woodrow
Wilson International Center for Scholars' Project on Emerging
Nanotechnologies has identified over 500 consumer products that already
are available to consumers that may contain nanoscale materials. For
example, nanoscale materials have been embedded into clothing fabric to
repel stains. Some nanoscale materials in development could greatly
improve pharmaceuticals because the materials' size, structure, and
behavior can be used, for example, to treat diseases by delivering
drugs directly to affected cells, such as tumor cells. Food companies
also are experimenting with nanoscale materials that can be
incorporated into food packaging to detect spoilage or pathogens, and
cosmetics companies have developed products with nanoscale materials
that reportedly enable sunscreens to perform better.
While the use of nanoscale materials holds much promise for the future,
the small size and unique properties of nanomaterials raise questions
about potential environmental, health, and safety (EHS) effects--
referred to as EHS risks--that might result from exposures during the
manufacture, use, and disposal or recycle of nanoscale materials. For
example, recent research suggests that nanomaterials are small enough
to get inside cells and some may cross the blood-brain barrier to
directly enter the central nervous system. Because nanotechnology is a
relatively new science, basic information about the properties of many
nanoscale materials is not fully known. Scientists are working to fill
significant gaps in current knowledge about nanoscale materials so they
can answer questions about potential EHS risks and help ensure the safe
commercial development of these materials.
In 2001, the National Nanotechnology Initiative (NNI) was established
as a federal, multiagency effort intended to accelerate the discovery,
development, and deployment of nanoscale science, engineering, and
technology to achieve economic benefits, enhance the quality of life,
and promote national security.[Footnote 1] The NNI is a mechanism to
coordinate the nanotechnology-related activities of the 25 currently
participating federal agencies that fund nanoscale research or have a
stake in the outcome of this research, such as those agencies that may
regulate products containing nanomaterials.[Footnote 2] While the NNI
is designed to facilitate intergovernmental cooperation and identify
overarching goals and priorities for nanotechnology research, it is not
a research program. It also has no funding or authority to dictate the
nanotechnology research agenda for participating agencies or to ensure
that adequate resources are available to achieve specific goals.
Instead, participating agencies develop and fund their own
nanotechnology research agendas. In fiscal year 2006, 13 of the 25
participating agencies in the NNI allocated a total of about $1.3
billion from their appropriated budgets to nanotechnology research and
development activities.
Management of the NNI falls under the purview of the National Science
and Technology Council (NSTC), a Cabinet-level body within the Office
of the President that coordinates science and technology policy across
the federal government. The NSTC's Committee on Technology has
established a Nanoscale Science, Engineering, and Technology (NSET)
subcommittee to help coordinate, plan, and implement the NNI's
activities across participating agencies. In 2003, the NSET
subcommittee further established a Nanotechnology Environmental and
Health Implications (NEHI) working group.[Footnote 3] The purpose of
the NEHI working group, composed of representatives from 16 research
and regulatory agencies, is to, among other things, coordinate agency
efforts related to EHS risks of nanotechnology. As is the case with the
NNI, the NEHI working group has no authority to mandate research
priorities or to ensure that agencies adequately fund particular
research.
In December 2003, Congress enacted the 21st Century Nanotechnology
Research and Development Act.[Footnote 4] The act establishes a
National Nanotechnology Program to coordinate federal nanotechnology
research and development. Among other things, the act directs the NSTC
to establish goals and priorities for the program and to set up program
component areas that reflect those goals and priorities. To implement
these requirements, the NSTC has established a process to categorize
research projects and activities undertaken by the various federal
agencies into seven areas. Of these seven, six are focused on the
discovery, development, and deployment of nanotechnology, while the
seventh relates to the societal dimensions of nanotechnology that
include issues such as the EHS risks of nanotechnology. Agencies also
report their research funding for each area to the Office of Management
and Budget (OMB) as part of the annual federal budget process. NNI's
annual Supplement to the President's Budget, prepared by the NSTC,
includes EHS research figures from the agencies and a general
description of the research conducted by the agencies in each of the
seven areas. For reporting purposes, the NSET subcommittee has defined
EHS research as "efforts whose primary purpose is to understand and
address potential risks to health and to the environment posed by this
technology." Eight of the 13 agencies that dedicated a portion of their
research budgets for nanotechnology research in fiscal year 2006
reported having devoted some resources to research that had a primary
focus on potential EHS risks. However, the Woodrow Wilson International
Center for Scholars has questioned the accuracy of reporting research
related to EHS risks. Furthermore, some groups, including industry,
environmental advocacy, and nonprofit research institutes, have raised
concerns about the pace of NEHI's prioritization activities as well as
the process it is using to identify research priorities and coordinate
federal research.
In this context you asked us to report on (1) the extent to which
selected research and regulatory agencies conducted research in fiscal
year 2006 that primarily was focused on the potential EHS risks of
nanotechnology; (2) the reasonableness of the processes that agencies
and the NNI use to identify and prioritize federal research on the
potential EHS risks of nanotechnology; and (3) the effectiveness of the
processes that agencies and the NNI use to coordinate their research.
To determine the extent to which selected research and regulatory
agencies conducted research that is primarily focused on studying the
EHS risks of nanotechnology, we gathered data on the funding that NNI's
participating agencies have used for EHS risk research. We focused our
review on the Environmental Protection Agency (EPA), the National
Institutes of Health (NIH), the National Institute for Occupational
Safety and Health (NIOSH), the National Institute of Standards and
Technology (NIST), and the National Science Foundation (NSF), because
these five agencies accounted for 96 percent of the EHS research
funding reported in fiscal year 2006. Of these agencies, NIH, NIOSH,
NIST, and NSF are research agencies that have specific budgets to
support research, including nanotechnology-related research. EPA on the
other hand is a regulatory agency that also conducts research and
therefore has a research budget. In addition to the agencies mentioned
above, we also included in our review three regulatory agencies that do
not have research budgets--the U.S. Consumer Product Safety Commission
(CPSC), the Food and Drug Administration (FDA), and the Occupational
Safety and Health Administration (OSHA) to determine whether these
three agencies conducted any research on their own relative to EHS
risks of nanotechnology. We assessed the reliability of the agencies'
data and determined it was sufficient for the purposes of this
analysis. To assess whether or not the primary purpose of the research
conducted by these agencies addressed the EHS risks of nanotechnology,
we reviewed qualitative data on all projects funded by EPA, NIH, NIOSH,
NIST, and NSF in fiscal year 2006. To minimize bias and to ensure the
consistency of our evaluation, the team independently conducted project
reviews by using publicly available and agency documentation, such as
project abstracts or grant applications, to make our determinations.
For categorization of projects that appeared questionable to us, we
discussed the categorization with agency officials and modified our
determination as appropriate given the additional support provided by
the agency.
To determine the reasonableness of the process that the agencies and
the NNI used to prioritize and coordinate federal research on studying
EHS risks, we collected and reviewed documentation on research
priorities, and the process used to establish these priorities, at each
of the eight agencies included in our review and compared these
priorities with funded research within the agency. To review the
process being used by the NNI to identify and establish government-wide
priorities, we reviewed NNI documents and interviewed agency officials
and external stakeholder groups, including officials from groups that
represent environmental and industry concerns. We compared the NNI's
identified priorities with those identified by the agencies to
determine whether they were consistent. We also compared the NNI's
identified priorities with agency project-level data on EHS research
underway in fiscal year 2006 to determine whether the projects were
reflective of NNI's identified priorities. We did not determine whether
the NNI's identified priorities represented a scientific consensus on
the most appropriate ones. We interviewed agency officials at each of
the eight agencies about the extent to which their agency's research
priorities were met, either through the agency's own research or
research conducted by other agencies. With regard to coordination, we
discussed with agency and NNI officials how agencies coordinate
research and NNI's role to facilitate that coordination, and we
obtained documentation on these collaborative efforts. Furthermore, we
compared the NNI's efforts to facilitate interagency collaboration with
established practices that have been found to enhance and sustain
collaboration among federal agencies. In addition, we interviewed
stakeholders, including environmental and industry groups, to obtain
views on agency coordination efforts. We conducted this performance
audit from June 2007 to February 2008 in accordance with generally
accepted government auditing standards. Those standards require that we
plan and perform the audit to obtain sufficient, appropriate evidence
to provide a reasonable basis for our findings and conclusions based on
our audit objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit
objectives.
Results in Brief:
Of the $1.3 billion that federal agencies allocated to nanotechnology
research in fiscal year 2006, the NNI reported that about $37 million
was devoted to research that primarily focused on studying the EHS
risks of nanotechnology. However, based on our analysis, about one-
fifth of this amount cannot actually be attributed to this purpose.
Specifically, our analysis found that 22 of the 119 projects identified
as EHS projects by EPA, NIH, NIOSH, NIST, and NSF in fiscal year 2006
were not primarily related to understanding the EHS risks of
nanotechnology. These 22 projects, funded by NSF and NIOSH, accounted
for about $7 million of the $37 million that the NNI reported as being
primarily focused on EHS risks. Instead of determining the extent to
which nanotechnology poses an EHS risk, the primary purpose of many of
these projects was to explore how nanotechnology could be applied to
remediate environmental damage or could be used to detect a variety of
hazards, such as chemical or biological. The miscategorization of these
22 projects results largely from a reporting structure for
nanotechnology research that does not easily allow agencies to
recognize projects that use nanotechnology to mitigate environmental
damage or enhance detection of environmental contaminants and from the
lack of guidance available to the agencies on how to apportion funding
across multiple topics, when appropriate. As a result, agency officials
said they characterized these projects as being EHS-focused for lack of
a more closely related category to place them in. We also determined
that some federal agencies conduct research that is not reported as
part of EHS research funding and is therefore not captured in the EHS
totals provided by the NNI. For example, NIH has research underway to
develop drug delivery mechanisms that use nanotechnology. This research
also will provide relevant health and safety information on how
nanomaterials interact with the body at the cellular level, but the
agency's funding for this type of research is not included in the NNI's
totals for EHS research because studying EHS risks was not its primary
purpose. We are recommending that the Office of Science and Technology
Policy (OSTP), in consultation with the NNI and OMB, provide better
guidance to agencies regarding how to report research that is primarily
focused on understanding or addressing the EHS risks of nanotechnology.
In commenting on this report, OSTP generally concurred with the
report's findings and agreed to review the manner in which agencies
respond to the current guidance at future NSET meetings.
The agencies and the NNI are currently in the process of identifying
and prioritizing EHS risk research needs; the process they are using
appears reasonable overall. Identification and prioritization of
research needs related to EHS risks takes place within individual
agencies as well as within the NNI. Agencies' priorities are linked to
their missions and are generally set by intra-agency teams dedicated to
nanotechnology issues. Most of the eight agencies we reviewed have
established internal task forces to identify and prioritize
nanotechnology research needs and to communicate these priorities to
the larger research community. In addition to these agency efforts, the
NSET subcommittee is currently engaged in an iterative prioritization
effort through its NEHI working group. This effort began with a
September 2006 report in which NEHI identified five general categories
of research necessary to evaluate EHS risks and a list of 75 specific
research needs, which were not prioritized at that time. Subsequently,
in an August 2007 report, NEHI distilled the list of 75 specific
research needs into a set of five prioritized needs under each of the
five general research categories. Agency officials told us that NEHI's
report generally reflects their agencies' key research priorities. NEHI
has not yet completed the final steps of this process and plans to
issue a report in early 2008 that will identify EHS research gaps;
determine specific research needed to fill those gaps; and outline a
long-term, overarching strategy to guide agency research funding
decisions. Furthermore, our analysis of the 97 research projects that
were underway in fiscal year 2006 that were primarily related to
studying EHS risks found that the focus of these projects was generally
consistent with agency priorities and NEHI's five general research
categories and that the projects focused on the priority needs within
each category to varying degrees. The anticipated 2008 NEHI report is
expected to provide a framework to help agencies better target the
highest priority research needs in the future. Also, some environmental
and industry groups have advocated for a more top-down and directed
approach for setting and funding federal nanotechnology research
priorities. However, such a structure and approach is generally
inconsistent with historical approaches used to set federal research
priorities and may be difficult to implement given how federal research
is currently funded.
Agency and NNI processes to coordinate activities related to the
potential EHS risks of nanotechnology have been generally effective.
The NEHI working group has convened frequent meetings, augmented by
informal discussions among agencies, that have helped agencies identify
opportunities to collaborate on EHS risk issues. These interagency
collaborations have taken many forms including joint sponsorship of EHS-
related research and workshops and detailing staff to work at other
NEHI participating agencies. These types of exchanges, according to
most agency officials we spoke with, have helped advance knowledge and
facilitated information-sharing among the agencies. In addition, NEHI
has incorporated several practices that we have previously identified
as key to enhancing and sustaining interagency collaborative efforts,
such as defining a common outcome and leveraging resources, but has not
completed an overarching strategy to help better align agencies' EHS
research efforts. Finally, all agency officials we spoke with expressed
satisfaction with both the coordination and the collaboration on EHS
risk research that has occurred through NEHI. These officials cited
several factors that they believe have contributed to the working
group's effectiveness, including the expertise, dedication, and low
turnover rate of its members. Furthermore, according to these
officials, this stability, combined with common research needs and
general excitement about the new science, has resulted in a collegial,
productive working environment.
Background:
Nanotechnology is generally defined as the ability to understand and
control matter at the nanoscale (between 1 and 100 nanometers), in
order to create materials, devices, and systems with fundamentally new
properties and functions specific to that scale. For example, opaque
materials, such as copper, become transparent at the nanoscale and
inert materials, such as platinum and gold, become chemical catalysts.
With the capacity to control and manipulate matter at this scale,
nanotechnology promises advances in areas such as new drug delivery
systems, more resilient materials and fabrics, stronger materials at a
fraction of the weight, more efficient energy conversion, and
dramatically faster computer chips.
To guide federal development of this technology, the National
Nanotechnology Initiative (NNI) was established in fiscal year 2001 to
support long-term research and development aimed at accelerating the
discovery, development, and deployment of nanoscale science,
engineering, and technology. The NNI is a multiagency program involving
nanotechnology-related activities of the 25 federal agencies currently
participating, including the National Science Foundation (NSF), the
Department of Defense, the Department of Energy, the National
Institutes of Health (NIH), and the National Institute of Standards and
Technology (NIST). See table 1 for a complete listing of federal
agencies participating in the NNI as of December 2007.
Table 1: Federal Agencies Participating in the National Nanotechnology
Initiative, as of December 2007:
Federal Agencies with Budgets Dedicated to Nanotechnology Research and
Development:
* Cooperative State Research, Education, and Extension Service;
* Department of Defense;
* Department of Energy;
* Department of Homeland Security;
* Department of Justice;
* Department of Transportation;
* Environmental Protection Agency;
* National Aeronautics and Space Administration;
* National Institute of Standards and Technology;
* National Institute for Occupational Safety and Health;
* National Institutes of Health;
* National Science Foundation;
* U.S. Forest Service;
Other Participating Agencies:
* Bureau of Industry and Security;
* Department of Education;
* Department of Labor;
* Department of State;
* Department of the Treasury;
* Food and Drug Administration;
* International Trade Commission;
* Intelligence Advanced Research Projects Activity;
* Nuclear Regulatory Commission;
* U.S. Consumer Product Safety Commission;
* U.S. Geological Survey;
* U.S. Patent and Trademark Office.
Source: NNI.
[End of table]
Federal support for nanotechnology research totaled about $1.3 billion
in fiscal year 2006. Cumulatively through fiscal year 2006, federal
agencies have devoted over $5 billion to nanotechnology research since
the NNI's inception. While not all of the NNI's participating agencies
conduct or sponsor research, in fiscal year 2006, 13 agencies had
budgets dedicated to nanotechnology research and development. Eight of
these 13 agencies devoted some of their research resources to studying
the environmental, health, and safety (EHS) risks of nanotechnology. Of
these eight agencies, five--EPA, NIH, NIOSH, NIST, and NSF--accounted
for almost 96 percent of the research focused on EHS risks in fiscal
year 2006. NSF alone accounted for about 56 percent of all federal EHS
risk research in fiscal year 2006. See figure 1 for a break out of
research funds used by agency.
Figure 1: Nanotechnology EHS Research by Agency, as Reported by the
National Nanotechnology Initiative, Fiscal Year 2006:
This figure is a pie chart showing nanotechnology EHS research by
agency, as reported by the National Nanotechnology Initiative, fiscal
year 2006.
Dollars in millions.
NSF: $21.0: 56%;
NIH: $5.2: 14%;
NIOSH: $3.8: 10%;
EPA: $3.7: 10%;
NIST: $2.4: 6%;
Other agency: $1.6: 4%.
[See PDF for image]
Source: GAO analysis of NNI budget data.
[End of figure]
A number of research and regulatory agencies support research to
advance knowledge and information about the potential EHS risks of
nanotechnology:
* The National Institute for Occupational Health and Safety (NIOSH) is
a research agency within the Department of Health and Human Services
(HHS) that concentrates its research on topics related to human health.
NIOSH's research results in recommendations for preventing work-related
injuries, illnesses, and death. It therefore focuses on studies that
will improve scientists' ability to identify potential adverse
occupational health effects of nanomaterials.
* At NIH, another HHS research agency that concentrates on human
health, nanotechnology research is generally focused on the development
of medical applications and the protection of public health, including
research to examine the interaction of nanomaterials with biological
systems.
* Consistent with its mission to advance measurement science,
standards, and technology to enhance economic security and improve our
quality of life, the National Institute of Standards and Technology
(NIST), an agency in the Department of Commerce, develops the
measurement techniques required to better characterize potential
impacts of nanotechnology.
* The National Science Foundation (NSF) has the broadest research
portfolio relative to nanotechnology and supports research to help meet
its mission to promote the progress of science and engineering. With
regard to EHS risks, NSF sponsors research to develop new methods to
characterize nanoparticles and investigate the environmental
implications and toxicity of nanomaterials. In addition, NSF sponsors a
network of research centers that focus on a range of EHS issues
including occupational safety during nanomanufacturing and the
interaction of nanomaterials and cells.
In addition to these research agencies, a number of regulatory agencies
also have an interest in developing information about the potential EHS
risks of nanotechnology:
* The Environmental Protection Agency (EPA), which is both a research
and regulatory agency, is tasked with protecting human health and the
environment. As a result, EPA determined that it needed to develop a
better understanding of the potential human health and environmental
risks from exposure to nanoscale materials and is therefore focusing
its research efforts in this area, among others.
* The Food and Drug Administration (FDA), another HHS agency, is
generally responsible for overseeing the safety and effectiveness of
drugs and devices for humans and animals, and of biological products
for humans. The agency also is generally responsible for overseeing the
safety of color additives, cosmetics, and foods, including food
additives and dietary supplements. As a result, FDA is interested in
understanding the potential risks posed by nanomaterials used in
products under its jurisdiction.
* The Occupation Safety and Health Administration (OSHA) is a
Department of Labor agency whose mission is, in part, to ensure the
safety and health of workers by setting and enforcing standards and
encouraging continual improvement in workplace safety and health. OSHA
is interested in information that would aid in the application of
existing health standards--including hazard communication, respiratory
protection programs, and laboratory standards--to nanotechnology
operations and help determine the need for new standards or guidance
products.
* The mission of the U.S. Consumer Product Safety Commission (CPSC) is
to protect the public from unreasonable risks of serious injury or
death from more than 15,000 types of consumer products, including some
that may be manufactured with nanomaterials.
The NNI is managed within the framework of the National Science and
Technology Council's (NSTC) Committee on Technology. The NSTC is an
organization through which the President coordinates science and
technology policies across the federal government. The NSTC is managed
by the Director of the Office of Science and Technology Policy (OSTP),
who also serves as the Science Advisor to the President. The NSTC's
Committee on Technology established the Nanoscale Science, Engineering,
and Technology (NSET) subcommittee to coordinate communication between
the federal government's multiagency nanoscale research and development
programs. The NSET subcommittee is composed of representatives from any
agencies that choose to participate in the NNI (as of January 2008, 25
agencies are involved) and serves as the primary interagency
coordination mechanism for nanotechnology-related research. Supporting
the NSET subcommittee, the National Nanotechnology Coordinating Office
(NNCO) provides day-to-day technical guidance and administrative
assistance to prepare multiagency planning, budget, and assessment
documents. In addition, the NSET subcommittee has established a number
of working groups to help better focus interagency attention and
activity on specific issues, such as the Nanotechnology Environmental
and Health Implications (NEHI) working group. This group was designed
to provide for exchange of information among participating agencies;
facilitate the identification, prioritization, and implementation of
research; and promote communication to other federal and nonfederal
entities. The NEHI working group also coordinates U.S. participation in
international activities, including the programs of the Organisation
for Economic Co-operation and Development. Currently, NEHI membership
consists of 16 research and regulatory agencies. See figure 2 for the
NNI's structure.
Figure 2: National Nanotechnology Initiative Structure:
This figure is a flowchart showing national nanotechnology initiative
structure.
[See PDF for image]
Source: NNI.
[End of figure]
Under the NNI, each agency funds research and development projects that
support its own mission as well as the NNI's goals. While agencies
share information on their nanotechnology-related research goals with
the NSET subcommittee and NEHI working group, each agency retains
control over its decisions on the specific projects to fund. While the
NNI was designed to facilitate intergovernmental cooperation and
identify goals and priorities for nanotechnology research, it is not a
research program. It has no funding or authority to dictate the
nanotechnology research agenda for participating agencies.
The NNI used its fiscal year 2000 strategic plan and its subsequent
updates to delineate a strategy to support long-term nanoscale research
and development, among other things. A key component of the 2000 plan
was the identification of nine specific research and development areas-
-known as "grand challenges"--that highlighted federal research on
applications of nanotechnology with the potential to realize
significant economic, governmental, and societal benefits.[Footnote 5]
Examples of potential breakthroughs cited in this strategic plan
included developing materials that are 10 times stronger, but
significantly lighter, than steel to make vehicles lighter and more
fuel efficient; improving the speed and efficiency of computer
transistors and memory chips by factors of millions; and developing
methods to detect cancerous tumors that are only a few cells in size
using nanoengineered contrast agents.
In 2004, the NNI updated its strategic plan and described its goals as
well as the investment strategy by which those goals were to be
achieved.[Footnote 6] Consistent with the 21st Century Nanotechnology
Research and Development Act, the NNI established major subject
categories of research and development investment, called program
component areas (PCA), that cut across the interests and needs of the
participating agencies.[Footnote 7] These seven areas replaced the nine
grand challenges and other nanotechnology investment areas that the
agencies had previously used to categorize their nanotechnology
research. Six of the seven areas are focused on the discovery,
development, and deployment of nanotechnology. The seventh, societal
dimensions, consists of two subareas--research on environmental,
health, and safety; and education and research on ethical, legal, and
other societal aspects of nanotechnology. The EHS portion of the
societal dimensions PCA accounted for over $37 million in fiscal year
2006. See figure 3 for a break out of research funds used, by PCA.
Figure 3: Nanotechnology Research Funding by Program Component Area,
Fiscal Year 2006:
This figure is a pie chart showing nanotechnology research funding by
program component area, fiscal year 2006.
Fundamental phenomena and processes: $455.9: 33%;
Nanomanufacturing: $33.8: 3%%;
Societal dimensions (education and ethical, legal, and other societal
issues): $35.7: 3%;
Societal dimensions (environmental, health, and safety R&D): $37.7: 3%;
Instrumentation research, metrology and standards: $51.1: 4%;
Major research facilities and instrumentation acquisition: $152.4: 11%;
Nanomaterials: $319.6: 23%.
[See PDF for image]
Source: GAO analysis of NNI budget data.
[End of figure]
PCAs are intended to provide a means by which the NSET subcommittee,
OSTP, the Office of Management and Budget (OMB), Congress, and others
may be informed of the relative federal investment in these key areas.
PCAs also provide a structure by which the agencies that fund research
and development can better direct and coordinate their activities. In
response to increased concerns about the potential EHS risks of
nanotechnology, in fiscal year 2005, the NSET subcommittee and the
agencies agreed to separately report their research funding for each of
the two components of the societal dimensions PCA. The December 2007
update of the NNI's strategic plan reaffirmed the program's goals,
identified steps to accomplish those goals, and formally divided the
societal dimensions PCA into two separate PCAs--"environment, health,
and safety" and "education and societal dimensions."
Beginning with the development of the fiscal year 2005 federal budget,
agencies have worked with OMB to identify funding for nanoscale
research that would be reflected in the NNI's annual Supplement to the
President's Budget. Specifically, OMB issued guidance that consisted of
a definition of nanoscale research and a notice that OMB would work
with agencies to identify data for each of the PCAs. OMB analysts
reviewed aggregated, rather than project-level, data on research
funding for each PCA to help ensure consistent reporting across the
agencies. Agencies also relied on definitions of the specific PCAs
developed by the NSET subcommittee to determine the appropriate area in
which to report research funding. Neither NSET nor OMB provided
guidance on whether or how to apportion funding for a single research
project to more than one PCA, if appropriate. However, representatives
from both NSET and OMB stressed that the agencies were not to report
each research dollar more than once.
Almost 20 Percent of EHS Research Projects Were Not Primarily Focused
on Studying the EHS Risks of Nanotechnology:
Although the NNI reported that federal agencies in fiscal year 2006
devoted $37.7 million--or about 3 percent of the total of all
nanotechnology research funding--to research that primarily focused on
studying the EHS risks of nanotechnology, we found that about 18
percent of the EHS research reported by the NNI cannot actually be
attributed to this purpose. This was largely due to a reporting
structure that did not lend itself to categorizing particular types of
projects and limited guidance provided to the agencies by the NNI on
how to consistently report EHS research. In addition to research
reported as being primarily focused on the EHS risks of nanotechnology,
some agencies conduct research that is not reflected in the EHS totals
provided by the NNI either because they are not considered federal
research agencies or because the primary purpose of the research was
not to study EHS risks.
EHS Research Constituted about 3 Percent of Federal Nanotechnology
Research Funding in Fiscal Year 2006:
Overall, 3 percent--or $37.7 million--of the approximately $1.3 billion
dedicated for nanotechnology research funding in fiscal year 2006 was
reported as being devoted to studying the EHS risks of nanotechnology.
Our review of data on agency funding for 119 projects that were
underway in fiscal year 2006 largely confirmed the figures reported by
the NNI. Specifically, all but one of the five individual agencies
reported the same or greater funding to us than what the NNI reported
for fiscal year 2006. EPA reported slightly less to us than it did to
the NNI. Largely these discrepancies resulted from timing differences
in the date the NNI needed the data and the date agency officials
finalized their review of fiscal year spending. For example, NIOSH
reported $470,000 more to us because it had not included funding for a
few projects in its report to the NNI, according to agency officials.
Other differences resulted from rounding.
As would be expected, our review of the descriptive information on EHS
projects found that those agencies with missions directly related to
protecting the environment or human health and safety devoted a greater
percentage of their nanotechnology research budgets to studying EHS
risks. For example, in fiscal year 2006, NIOSH reported devoting 100
percent of its fiscal year 2006 nanotechnology research funds to
support 23 projects to study EHS risks. These projects focused
primarily on worker safety and exposure, such as gathering data on
workplace exposure to nanomaterials and evaluating the extent to which
particle size affects the toxicity of inhaled nanomaterials. Similarly,
EPA reported devoting 82 percent of its nanotechnology research budget
to study EHS risks. This research included human health-focused
projects to examine the toxicity of manufactured nanomaterials at the
molecular and cellular level, as well as environmentally focused
projects to evaluate how nanomaterials disperse and change under
different environmental conditions and the extent to which
nanomaterials accumulate in the bodies of various animal species.
In contrast, we found that agencies with broader missions devoted a
smaller portion of their nanotechnology research funds to study EHS
issues. For example, NIST, an agency oriented toward measurement
science and standards, dedicated 3 percent of its nanotechnology
research budget to EHS risks in fiscal year 2006. The majority of its
research funding focused on such PCAs as fundamental phenomena and
processes; nanoscale devices and systems; and instrumentation research,
metrology, and standards. Similarly, NSF dedicated 6 percent of its
fiscal year 2006 nanotechnology research funds on research related to
EHS risks as compared with 41 percent focused on fundamental phenomena
and processes.
In fiscal year 2008, funding for both EHS-related research and
nanoscale research in general is projected to grow. Overall
nanotechnology research is projected to increase in fiscal year 2008 to
about $1.4 billion, or an increase of 20 percent over fiscal year 2005
figures. Funding for EHS-related research is expected to increase to
approximately $59 million, an increase of 68 percent over fiscal year
2005 levels. As a result, EHS research would grow to about 4 percent of
projected nanotechnology research in fiscal year 2008.
Current Reporting Structure and Limited Guidance Contribute to
Inaccurate Reporting of EHS Risk Research:
About 18 percent of the total research dollars reported by the agencies
as being primarily focused on the study of nanotechnology-related EHS
risks in fiscal year 2006 cannot actually be attributed to this
purpose. Specifically, our analysis found that 22 of the 119 projects
funded by five federal agencies were not primarily related to studying
EHS risks. These 22 projects accounted for about $7 million of the
total that the NNI reported as supporting research primarily focused on
EHS risks. Almost all of these projects--20 out of 22--were funded by
NSF, with the two additional projects funded by NIOSH. See table 2 for
our analysis of the nanotechnology research projects reported as being
primarily focused on EHS risks.
Table 2: GAO Analysis of the Number and Dollar Value of Nanotechnology
Research Projects Reported by Selected Agencies as Being Primarily
Focused on Environmental, Health, and Safety Risks, Fiscal Year 2006:
(Dollars in millions).
Agency: EPA;
Projects reported by agencies as being primarily focused on EHS: 10;
Projects reported by agencies as being primarily focused on EHS: $3.6;
Projects determined by GAO to be primarily focused on EHS: Number: 10;
Projects determined by GAO to be primarily focused on EHS: $3.6;
Projects determined by GAO not to be primarily focused on EHS: Number:
0;
Projects determined by GAO not to be primarily focused on EHS: $0.
Agency: NIH;
Projects reported by agencies as being primarily focused on EHS: 18;
Projects reported by agencies as being primarily focused on EHS: $5.6;
Projects determined by GAO to be primarily focused on EHS: Number: 18;
Projects determined by GAO to be primarily focused on EHS: $5.6;
Projects determined by GAO not to be primarily focused on EHS: Number:
0;
Projects determined by GAO not to be primarily focused on EHS: $0.
Agency: NIOSH;
Projects reported by agencies as being primarily focused on EHS: 23;
Projects reported by agencies as being primarily focused on EHS: $4.3;
Projects determined by GAO to be primarily focused on EHS: Number: 21;
Projects determined by GAO to be primarily focused on EHS: $4.2;
Projects determined by GAO not to be primarily focused on EHS: Number:
2;
Projects determined by GAO not to be primarily focused on EHS: $0.1.
Agency: NIST;
Projects reported by agencies as being primarily focused on EHS: 2;
Projects reported by agencies as being primarily focused on EHS: $2.4;
Projects determined by GAO to be primarily focused on EHS: Number: 2;
Projects determined by GAO to be primarily focused on EHS: $2.4;
Projects determined by GAO not to be primarily focused on EHS: Number:
0;
Projects determined by GAO not to be primarily focused on EHS: $0.
Agency: NSF;
Projects reported by agencies as being primarily focused on EHS: 66;
Projects reported by agencies as being primarily focused on EHS: $21.1;
Projects determined by GAO to be primarily focused on EHS: Number: 46;
Projects determined by GAO to be primarily focused on EHS: $14.7;
Projects determined by GAO not to be primarily focused on EHS: Number:
20;
Projects determined by GAO not to be primarily focused on EHS: $6.4.
Total;
Projects reported by agencies as being primarily focused on EHS: 119;
Projects reported by agencies as being primarily focused on EHS: $37;
Projects determined by GAO to be primarily focused on EHS: Number: 97;
Projects determined by GAO to be primarily focused on EHS: $30.5;
Projects determined by GAO not to be primarily focused on EHS: Number:
22;
Projects determined by GAO not to be primarily focused on EHS: $6.5.
Source: GAO analysis of agency obligations data.
[A] Figures differ slightly from those reported by the NNI in the
Supplement to the President's FY2008 Budget due to rounding error or
modifications made to the project-level data after they were reported
by agencies to the NNI.
[End of table]
We found that the primary purpose of many of these 22 projects was to
explore ways to use nanotechnology to remediate environmental damage or
to identify environmental, chemical, or biological hazards. For
example, a number of NSF projects explored the use of nanotechnology to
improve water or gaseous filtration systems. In other cases, NSF-funded
research was targeted toward developing nanotechnology-based
applications to remediate soil or water contamination. In addition,
many of the projects NSF reported as having a primary purpose to study
EHS risks were part of its efforts to build a national research
infrastructure capable of supporting a wide range of nanotechnology-
related research. Specifically, NSF sponsors 16 Nanoscale Science and
Engineering Centers, many of which devote a portion of their research
efforts to EHS risk-related projects. In these cases, NSF apportioned a
segment of the Center funding to the EHS category to account for this
research. At NIOSH, both projects that we identified as not being
primarily focused on studying EHS risks were focused on using
nanotechnology to mitigate workplace risks, such as developing advanced
sensors that incorporate nanotechnology to detect the presence of toxic
gases in the workplace.
We found that the miscategorization of these 22 projects resulted
largely from a reporting structure for nanotechnology research that
does not easily allow agencies to recognize projects that use
nanotechnology to improve the environment or enhance the detection of
environmental contaminants, and from the limited guidance available to
the agencies on how to consistently report EHS research. From fiscal
years 2001 to 2004, the NSET subcommittee categorized federal research
and development activities into nine categories, known as "grand
challenges," that included one focused on "nanoscale processes for
environmental improvement." Agencies funded and researchers initiated
work on many of these 22 projects under the grand challenges
categorization scheme. Starting in fiscal year 2005, NSET adopted a new
categorization scheme for agencies to report their nanotechnology
research. The new scheme, which was based on PCAs, eliminated the
environmental improvement applications research category. Instead,
agencies were asked to fund and report research designed to address or
understand the risks associated with nanotechnology, as part of the
societal dimensions PCA. In essence, the new scheme shifted the focus
from applications-oriented research to research focused on the EHS
implications of nanotechnology. However, under the new scheme, agencies
no longer had a way to categorize environmentally focused research that
had been initiated. As a result, NSF and NIOSH characterized these
projects as EHS focused for lack of a more closely related category to
place them in, according to program managers. Furthermore, neither NSET
nor OMB provided agencies guidance on to how to apportion the dollars
for a single project to more than one program component area, when
appropriate. This is especially significant for broad, multiphase
research projects, such as NSF's support to develop networks of
research facilities with the capability to address a range of
nanotechnology-related topics. Of the five agencies we reviewed, only
NSF apportioned funds for a single project to more than one PCA.
Agencies Conduct Additional Research that Also Helps Advance Scientific
Knowledge of Potential EHS Risks:
In addition to research reported to the NNI as being primarily focused
on the EHS risks of nanotechnology, some agencies conduct research that
is not reflected in the EHS totals provided by the NNI either because
they are not considered federal research agencies or because the
primary purpose of the research was not to study EHS risks. For
example, FDA, which does not have a specific research budget and does
not generally track nanotechnology research spending, used a portion of
its operating funds in fiscal years 2004 through 2007 to undertake 15
research projects to evaluate the potential health risks of
nanomaterials in the products that it regulates. One such project
focused on sunscreens that contain nanosized particles of titanium
dioxide to better understand their potential to be absorbed into the
body through the skin. Another project is designed to study the
toxicological and immunological responses to nanoparticles that may be
used in therapeutic drugs. A fundamental understanding of potential
risks will help FDA develop guidance and make future regulatory
decisions regarding the manufacture and use of FDA-regulated products
using these materials, according to program managers.
In addition, as noted in the NNI's annual Supplement to the President's
Budget, some agencies conduct research that results in information
highly relevant to EHS risks but that was not primarily directed at
understanding or addressing those risks and therefore is not captured
in the EHS total. For example, NIH has research underway to develop
drug delivery mechanisms that use nanotechnology. While the primary
purpose of such research is to develop medical applications using
nanotechnology, the research also provides information on how toxic the
nanomaterials are, whether they accumulate in body tissues, and how
they interact with the body at the cellular and molecular level.
Agencies report funding data for such research in other PCAs, such as
nanoscale devices and systems, rather than the EHS area. In addition,
NIST conducts an array of nanotechnology research to accurately
quantify the properties of nanomaterials and determine their size,
shape, and chemical composition. This type of information is needed to
understand and measure nanomaterials to ensure safe handling and
protection against potential health or environmental hazards. However,
NIST reports the funding data for such research under other PCAs such
as instrumentation research, metrology, and standards.
Processes to Identify and Prioritize Needed EHS Research Appear
Reasonable and Are Ongoing but a Comprehensive Research Strategy Has
Not Yet Been Developed:
Ongoing agency and NEHI working group efforts to identify and
prioritize needed research related to the potential EHS risks of
nanotechnology appear reasonable but have not as yet resulted in a
comprehensive research strategy to guide EHS research across agencies.
We found that the EHS risk research undertaken in fiscal year 2006
addressed a range of EHS topics, was generally consistent with both
agency-and NEHI-identified research priorities, and focused on the
priority needs within each category to varying degrees.
Agencies Have Identified Their EHS Research Priorities:
We determined that each agency's nanotechnology research priorities
generally reflect its mission. For example, the priorities identified
by FDA and CPSC are largely focused on the detection and safety of
nanoparticles in the commercial products they regulate. On the other
hand, EHS research priorities identified by NSF reflect its broader
mission to advance science in general, and include a more diverse range
of priorities, such as the safety and transport of nanomaterials in the
environment, and the safety of nanomaterials in the workplace.
All eight agencies in our review have processes in place to identify
and prioritize the research they need related to the potential EHS
risks of nanotechnology. Most agencies have developed task forces or
designated individuals to specifically consider nanotechnology issues
and identify priorities, although the scope and exact purpose of these
activities differ by agency. EPA, for example, formed a Nanomaterial
Research Strategy Team to craft a long-term, focused plan to guide all
of the agency's nanotechnology research. The strategy, which identifies
EPA's research priorities around four key themes and seven scientific
questions, is based in part on the agency's 2007 "Nanotechnology White
Paper" that described scientific issues the agency should consider to
help ensure safe development of nanotechnology and to understand the
potential risks. At other agencies, particularly those that have little
or no funding for nanotechnology research, specific individuals
throughout the agency have been tasked to identify and prioritize EHS
research needs. For example, CPSC has assigned individual staff
responsible for different aspects related to consumer product safety,
such as health scientists, to monitor trends in the use of
nanomaterials in such products, which helps inform the agency's
nanotechnology research priorities. Once identified, agencies
communicate their EHS research priorities to the public and to the
research community in a variety of ways, including publication in
agency documents that specifically address nanotechnology issues,
agency strategic plans or budget documents, agency Web sites, and
presentations at public conferences or workshops.
NNI's Efforts to Prioritize Research Needs Are Ongoing:
In addition to the efforts of individual agencies, the NSET
subcommittee has engaged in an iterative prioritization process through
its NEHI working group, although this process is not yet complete.
First, in 2006, NEHI identified but did not prioritize five broad
research categories and 75 more specific subcategories of needs where
additional information was considered necessary to further evaluate the
potential EHS risks of nanotechnology.[Footnote 8] The report
identified these five general research categories as (1)
Instrumentation, Metrology, and Analytical Methods; (2) Nanomaterials
and Human Health; (3) Nanomaterials and the Environment; (4) Health and
Environmental Exposure Assessment; and (5) Risk Management
Methods.[Footnote 9] Second, following efforts to obtain public input
on its 2006 report, NEHI released another report in August
2007,[Footnote 10] in which it distilled the previous list of 75
unprioritized specific research needs into a set of five prioritized
needs for each of the five general research categories.[Footnote 11]
The NEHI working group has used these initial steps to identify the
gaps between the needs and priorities it has identified and the
research that agencies have underway. According to agency and NNI
officials, once this gap analysis is complete, NEHI will formulate a
long-term, overarching EHS research strategy. According to the August
2007 report, the proposed strategy will list NEHI's final research
priorities, describe current federal EHS research, document the unmet
needs, identify opportunities for interagency collaboration, and
establish a process for periodic review. As envisioned, the EHS
research strategy will serve as guidance for individual agencies as
they develop their own research agendas and make funding decisions.
NEHI plans to complete this overarching research strategy and issue a
report in early 2008, according to NNI officials.
Agencies' and the NNI's Prioritization Processes Appear Reasonable:
Despite the fact that a comprehensive research strategy for EHS
research has yet to be finalized, the prioritization processes taking
place within individual agencies and the NNI appear so far to be
reasonable. Numerous agency officials said their agency's EHS research
priorities were generally reflected both in the NEHI working group's
2006 research needs and 2007 research prioritization reports. Our
comparison of agency nanotechnology priorities to the NNI's priorities
corroborated their statements. Specifically, we found that all but one
of the research priorities identified by individual agencies could be
linked to one or more of the five general research categories. For
example, OSHA's need for toxicity data and information related to
exposure is reflected in the two general research categories of Health
and Environmental Exposure Assessment and Nanomaterials and Human
Health. According to agency officials, the alignment of agency
priorities with the general research categories is particularly
beneficial to the regulatory agencies, such as CPSC and OSHA, which do
not conduct their own research, but rely instead on research agencies
for data to inform their regulatory decisions.
In addition, we found that the primary purposes of agency projects
underway in fiscal year 2006 were generally consistent with both agency
priorities and the NEHI working group's research categories. Of these
97 projects, 43 were focused on Nanomaterials and Human Health,
including all 18 of the projects funded by NIH. In addition, EPA,
NIOSH, and NSF each undertook research for this general research
category. EPA and NSF funded all 25 projects related to Nanomaterials
and the Environment. These two general research categories accounted
for 70 percent of all projects focused on EHS risks. Reflective of its
relatively large EHS research budget and broad mission, NSF sponsored
projects in each of the five general research categories. In contrast,
all the research projects NIST sponsored were related to
Instrumentation, Metrology, and Analytical Methods.
Agency research addressed each of the five general research categories
and focused on the priority needs within each category to varying
degrees. With the exception of the Human Health category, for which all
specific needs were considered a top priority, 43 percent of projects
addressed the two highest-priority needs in each category and 37
percent addressed the two lowest-priority needs. For example, 8 of the
11 projects in the Instrumentation, Metrology, and Analytic Methods
category focused on the highest-priority need to "develop methods to
detect nanomaterials in biological matrices, the environment, and the
workplace." In contrast, of the 25 projects related to Nanomaterials
and the Environment, 3 addressed the highest-priority need in the
category--"understand the effects of engineered nanomaterials in
individuals of a species and the applicability of testing schemes to
measure effects"--and 11 addressed the fourth-ranked priority--
"determine factors affecting the environmental transport of
nanomaterials." Moreover, although the NEHI working group considered
the five specific research priorities related to human health equally
important, 19 of the 43 projects focused on a single priority--
"research to determine the mechanisms of interaction between
nanomaterials and the body at the molecular, cellular, and tissular
levels." See table 3 for a summary of projects by agency and specific
NEHI research priority.
Table 3: Research Primarily Focused on the Environmental, Health, and
Safety Risks of Nanotechnology by Agency and Specific Nanotechnology
Environmental and Health Implications Working Group Research Priority:
Instrumentation, Metrology, and Analytical Methods;
EPA: 0;
NIH: 0;
NIOSH: 1;
NIST: 2;
NSF: 8;
Total: 11.
Instrumentation, Metrology, and Analytical Methods: 1. Develop methods
to detect nanomaterials in biological matrices, the environment, and
the workplace;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: 1;
NSF: 7;
Total: 8.
Instrumentation, Metrology, and Analytical Methods: 2. Understand how
chemical and physical modifications affect the properties of
nanomaterials;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Instrumentation, Metrology, and Analytical Methods: 3. Develop methods
for standardizing assessment of particle size, size distribution,
shape, structure, and surface area;
EPA: [Empty];
NIH: [Empty];
NIOSH: 1;
NIST: 1;
NSF: [Empty];
Total: 2.
Instrumentation, Metrology, and Analytical Methods: 4. Develop
certified reference materials for chemical and physical
characterization of nanomaterials;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Instrumentation, Metrology, and Analytical Methods: 5. Develop methods
to characterize a nanomaterial's spatio-chemical composition, purity,
and heterogeneity;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 1;
Total: 1.
Nanomaterials and Human Health;
EPA: 4;
NIH: 18;
NIOSH: 10;
NIST: 0;
NSF: 11;
Total: 43.
Nanomaterials and Human Health: 1. Develop methods to quantify and
characterize exposure to nanomaterials and characterize nanomaterials
in biological matrices[A];
EPA: 1;
NIH: 1;
NIOSH: 4;
NIST: [Empty];
NSF: 2;
Total: 8.
Nanomaterials and Human Health: 2. Understand the absorption and
transport of nanomaterials throughout the human body[A];
EPA: 1;
NIH: 1;
NIOSH: [Empty];
NIST: [Empty];
NSF: 2;
Total: 4.
Nanomaterials and Human Health: 3. Establish the relationship between
the properties of nanomaterials and uptake via the respiratory or
digestive tracts or through the eyes or skin, and assess body
burden[A];
EPA: [Empty];
NIH: 5;
NIOSH: 3;
NIST: [Empty];
NSF: 1;
Total: 9.
Nanomaterials and Human Health: 4. Determine the mechanisms of
interaction between nanomaterials and the body at the molecular,
cellular, and tissular levels[A];
EPA: 1;
NIH: 10;
NIOSH: 3;
NIST: [Empty];
NSF: 5;
Total: 19.
Nanomaterials and Human Health: 5. Identify or develop appropriate in
vitro and in vivo assays/ models to predict in vivo human responses to
nanomaterials exposure[A];
EPA: 1;
NIH: 1;
NIOSH: [Empty];
NIST: [Empty];
NSF: 1;
Total: 3.
Nanomaterials and the Environment;
EPA: 5;
NIH: 0;
NIOSH: 0;
NIST: 0;
NSF: 20;
Total: 25.
Nanomaterials and the Environment: 1. Understand the effects of
engineered nanomaterials in individuals of a species and the
applicability of testing schemes to measure effects;
EPA: 1;
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 2;
Total: 3.
Nanomaterials and the Environment: 2. Understand environmental
exposures through identification of principle sources of exposure and
exposure routes;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 1;
Total: 1.
Nanomaterials and the Environment: 3. Evaluate abiotic and ecosystem-
wide effects;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 6;
Total: 6.
Nanomaterials and the Environment: 4. Determine factors affecting the
environmental transport of nanomaterials;
EPA: 2;
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 9;
Total: 11.
Nanomaterials and the Environment: 5. Understand the transformation of
nanomaterials under different environmental conditions;
EPA: 2;
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 2;
Total: 4.
Health and Environmental Exposure Assessment;
EPA: 0;
NIH: 0;
NIOSH: 3;
NIST: 0;
NSF: 2;
Total: 5.
Health and Environmental Exposure Assessment: 1. Characterize exposures
among workers;
EPA: [Empty];
NIH: [Empty];
NIOSH: 2;
NIST: [Empty];
NSF: 1;
Total: 3.
Health and Environmental Exposure Assessment: 2. Identify population
groups and environments exposed to engineered nanoscale materials;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Health and Environmental Exposure Assessment: 3. Characterize exposure
to the general population from industrial processes and industrial and
consumer products containing nanomaterials;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Health and Environmental Exposure Assessment: 4. Characterize health of
exposed populations and environments;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Health and Environmental Exposure Assessment: 5. Understand workplace
processes and factors that determine exposure to nanomaterials;
EPA: [Empty];
NIH: [Empty];
NIOSH: 1;
NIST: [Empty];
NSF: 1;
Total: 2.
Risk Management Methods;
EPA: 1;
NIH: 0;
NIOSH: 7;
NIST: 0;
NSF: 5;
Total: 13.
Risk Management Methods: 1. Understand and develop best workplace
practices, processes, and environmental exposure controls;
EPA: [Empty];
NIH: [Empty];
NIOSH: 4;
NIST: [Empty];
NSF: 2;
Total: 6.
Risk Management Methods: 2. Examine product or material life cycle to
inform risk reduction decisions;
EPA: 1;
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: 1;
Total: 2.
Risk Management Methods: 3. Develop risk characterization information
to determine and classify nanomaterials based on physical or chemical
properties;
EPA: [Empty];
NIH: [Empty];
NIOSH: 1;
NIST: [Empty];
NSF: 2;
Total: 3.
Risk Management Methods: 4. Develop nanomaterial-use and safety-
incident trend information to help focus risk management efforts;
EPA: [Empty];
NIH: [Empty];
NIOSH: [Empty];
NIST: [Empty];
NSF: [Empty];
Total: 0.
Risk Management Methods: 5. Develop specific risk communication
approaches and materials;
EPA: [Empty];
NIH: [Empty];
NIOSH: 2;
NIST: [Empty];
NSF: [Empty];
Total: 2.
Total;
EPA: 10;
NIH: 18;
NIOSH: 21;
NIST: 2;
NSF: 46;
Total: 97.
Source: GAO analysis of agency data.
[A] Priorities given equal weight.
[End of table]
Despite the fact that the NEHI working group's priorities reflect
individual agency priorities, some environmental and industry groups
have called for a more top-down and directed approach to the NNI's
prioritization efforts. In various congressional testimonies and in
written comments on the NEHI working group's draft reports, some groups
have suggested that the NNI adopt a stronger, more autonomous role in
setting the federal EHS research agenda. Some of these groups suggest
that the NNI should have the authority to direct participating agencies
to undertake research in specific EHS areas, its own budget authority,
and the ability to shift EHS research dollars among the agencies.
Proponents believe that this more centralized approach would help
ensure that a cohesive EHS research strategy is implemented in a timely
manner and that sufficient resources are dedicated to the highest-
priority research.
However, such a strategy may not be consistent with historical
approaches used to set federal research priorities and would be
difficult to implement given how federal research currently is funded.
Federal expenditures for research and development are regular budget
items and are contained, along with other types of expenditures, within
the budgets of more than 20 federal agencies. For some of these
agencies, research is a major activity, and for others, it is a smaller
part of a much larger set of programs. Centralizing nanotechnology
research expenditures in a single existing agency or new agency would
be difficult to achieve. In addition, agency officials we spoke with
were generally satisfied with the current bottom-up, consensus-based
approach. Moreover, they said the process has benefited from the in-
depth expertise each agency has developed. For example, NIH played a
large role in shaping the priorities for Nanomaterials and Human
Health; NIST was heavily involved with Instrumentation, Metrology, and
Analytical Methods; and NIOSH was a major contributor to the
development of priorities for Health and Environmental Exposure
Assessment. Some officials acknowledged that while the current approach
has limitations, it benefits from the input of a broader range of
stakeholders. According to one official, information bubbles up through
the NNI structure and is utilized to inform and create a top-down
vision, which then serves to guide agency funding decisions.
Coordination Processes Have Fostered Interagency Collaboration and
Information-Sharing:
Agency and NNI processes to coordinate research and other activities
related to the potential EHS risks of nanotechnology have been
generally effective, and have resulted in numerous interagency
collaborations. In fact, all eight agencies in this review have
collaborated on multiple occasions with other NEHI-member agencies on
activities related to the EHS risks of nanotechnology. These EHS-
related activities are consistent with the expressed goals of the
larger NNI--to promote the integration of federal efforts through
communication, coordination, and collaboration. The NEHI working group
is at the center of this effort. Regular NEHI working group meetings,
augmented by informal discussions, have provided a venue for agencies
to exchange information on a variety of topics associated with EHS
risks, including their respective research needs and opportunities for
collaborations.
Interagency collaboration has taken many forms, including joint
sponsorship of EHS-related research and workshops, the detailing of
staff to other NEHI working group agencies, and various other general
collaborations or memoranda of understanding. For example, FDA, NIST,
and NIH's Nanotechnology Characterization Laboratory have initiated
formal agreements to collaborate on research to characterize the
physical and biological properties of nanomaterials used in cancer
diagnosis and treatment.[Footnote 12] An FDA official said that this
arrangement was developed primarily through discussions that occurred
as a result of the agencies' participation in NEHI. Participation in
NEHI has helped facilitate other types of interagency collaborations
including a 2007 memorandum of understanding between EPA and NSF to
create and fund research at a virtual Center for the Environmental
Implications of Nanotechnology, detailing a CPSC toxicologist to a
research laboratory office at EPA, and sponsoring international
conferences on nanotechnology and occupational health by all NNI
agencies, led by NIOSH, in 2005, 2006, and 2007. See table 4 for more
examples of interagency collaboration.
Table 4: Examples of Agency Collaborations Related to Potential EHS
Risks of Nanotechnology:
General Collaborations: * NIH's National Characterization Laboratory,
in partnership with FDA and NIST, is developing characterization
methods to evaluate nanomaterials intended for cancer treatments.
General Collaborations: * EPA and NSF signed a memorandum of
understanding to create and fund research at a virtual Center for the
Environmental Implications of Nanotechnology.
General Collaborations: * CPSC, FDA, NIH, and NIOSH have participated
collaboratively on the Toxicological Evaluation of Nanoscale Materials
program within the National Toxicology Program.
General Collaborations: * NIOSH and OSHA have collaborated to develop
guidelines for working with engineered nanomaterials.
General Collaborations: * NIH and NIST have collaborated to
characterize properties of nanoparticles commonly used in sunscreen
lotions.
General Collaborations: * Staff from NIST and CPSC have been detailed
to other NNI agencies.
Grant Solicitations: * EPA, NIH, NIOSH, and NSF have issued interagency
competitive grant announcements through EPA's Science to Achieve
Results program to address various environmental and health
implications of nanotechnology.
Grant Solicitations: * EPA, NIH, and NIOSH have developed an
interagency Funding Opportunity Announcement to investigate the
biocompatibility and toxicity of industrial nanomaterials in mammals.
Grant Solicitations: * EPA and NIOSH have funded research on the
dispersion of nanoscale particulate aerosols.
Workshops: * NIOSH and other NNI agencies have sponsored international
conferences on nanotechnology and occupational health in 2005, 2006,
and 2007.
Workshops: * NSF has facilitated meetings for NSF grantees on the EHS
aspects of nanotechnology with participation from other NNI agencies.
Source: GAO.
[End of table]
Furthermore, the NEHI working group has adopted a number of practices
GAO has previously identified as essential to helping enhance and
sustain collaboration among federal agencies.[Footnote 13] For example,
NEHI's 2005 "Terms of Reference" clearly defined its purpose and
objectives and delineated roles and responsibilities for group members.
Furthermore, collaboration through multiagency grant announcements and
jointly sponsored workshops has served as a mechanism to leverage
limited resources to achieve increased knowledge about potential EHS
risks. Despite the general effectiveness of its collaboration efforts,
the NEHI working group has not yet completed an overarching strategy to
help align the agencies' EHS research efforts. A completed strategy,
combined with the results of the research needs prioritization process,
also will serve as a means to monitor, evaluate, and report on the
progress of meeting EHS research needs. In the meantime, the NNI's
annual Supplements to the President's Budget have described the
agencies' activities related to EHS issues, among other things, and
provided a mechanism to reinforce agency accountability and
performance.
Finally, all agency officials we spoke with expressed satisfaction with
their agency's participation in the NEHI working group, specifically,
the coordination and collaboration on EHS risk research and other
activities that have occurred as a result of their participation. Many
officials described NEHI as unique among interagency efforts in terms
of its effectiveness. Given limited resources, the development of
ongoing relationships between agencies with different missions, but
compatible nanotechnology research goals, is particularly important.
NIH officials commented that their agency's collaboration with NIST to
develop standard reference materials for nanoparticles may not have
occurred as readily had it not been for regular NEHI meetings and
workshops. In addition, NEHI has effectively brought together research
and regulatory agencies, which has enhanced planning and coordination.
Many officials noted that participation in NEHI has frequently given
regulators the opportunity to become aware of and involved with
research projects at a very early point in their development, which has
resulted in research that better suits the needs of regulatory
agencies. Participation in NEHI is particularly important for agencies
like CPSC, FDA, and OSHA that do not have dedicated budgets for
nanotechnology research.
Many officials also cited the dedication of individual NEHI working
group representatives, who participate in the working group in addition
to their regular agency duties, as critical to the group's overall
effectiveness. A number of the members has served on the body for
several years, providing stability and continuity that contributes to a
collegial and productive working atmosphere. In addition, because
nanotechnology is relatively new with many unknowns, these officials
said the agencies are excited about advancing knowledge about
nanomaterials and contributing to the informational needs of both
regulatory and research agencies. Furthermore, according to some
officials, there is a shared sense among NEHI representatives of the
need to apply lessons learned from the development of past
technologies, such as genetically modified organisms, to help ensure
the safe development and application of nanotechnology.
Conclusions:
Nanotechnology is likely to affect many aspects of our daily lives in
the future as novel drug delivery systems, improved energy storage
capabilities, and stronger, lightweight materials are developed and
made available to the public. However, for a technology that may become
ubiquitous, it is essential to consider the potential risks of using
nanotechnology in concert with its potential benefits. The first steps
are to identify what is not known about the properties of nanomaterials
and what must be known about how these materials interact with our
bodies and our environment. The NNI, through its NEHI working group,
has begun a process to identify and prioritize both the research needed
to better understand potential EHS risks and the gaps between what
research is underway and the highest-priority needs. Essential to this
process is consistent, accurate, and complete information on the amount
of agency research designed to address and understand EHS risks.
However, this information is not currently available because the totals
reported by the NNI include research that is more closely related to
uses of nanotechnology, rather than the risks nanotechnology may pose.
Furthermore, agencies currently have limited guidance on how to report
projects with more than one research focus across program component
areas, when appropriate. As a result, the inventory of projects
designed to address these risks is inaccurate and cannot ensure that
agencies direct their future research investments appropriately.
Recommendation for Executive Action:
We recommend that the Director, OSTP, in consultation with the
Director, NNCO, and the Director, OMB, provide better guidance to
agencies regarding how to report research that has a primary focus to
understand or address environmental, health, and safety risks of
nanotechnology.
Agency Comments and Our Evaluation:
We provided CPSC, FDA, EPA, NIH, NIOSH, NIST, NSF, OSHA, and OSTP with
a copy of this report for review and comment. OSTP generally concurred
with the report's findings and agreed to review the manner in which
agencies respond to the current guidance at future NSET meetings. In
addition, the Department of Health and Human Services, on behalf of
FDA, NIH, and NIOSH, said that the report clearly addressed the three
charges that GAO was given and they provided technical comments which
we incorporated as appropriate. In its comments, NIST said the report
was fair and balanced. EPA, CPSC, NSF, and OSHA neither agreed nor
disagreed with our report, and EPA and CPSC provided technical comments
that we incorporated as appropriate. See appendices I, II, and III for
agency comment letters from OSTP, HHS, and NIST, respectively.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to interested
congressional committees and Members of Congress, the Secretary of
Commerce, Secretary of Health and Human Services, the CPSC
Commissioner, the EPA Administrator, the FDA Commissioner, the NIH
Director, the NIOSH Director, the NIST Director, the NSF Director, the
OSHA Administrator, and the OSTP Director. We will also make copies
available to others upon request. In addition, the report will be
available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staffs have questions about this report, please contact
me at (202) 512-3841 or mittala@gao.gov. Contact points for our Offices
of Congressional Relations and Public Affairs may be found on the last
page of this report. GAO staff who made key contributions to this
report are listed in appendix IV.
Signed by:
Anu K. Mittal:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Comments from the Office of Science and Technology Policy:
Executive Office Of The President:
Office Of Science And Technology Policy:
Washington, D.C. 20502:
March 3, 2008:
Ms. Anu Mittal:
Director of Natural Resources and Environment:
U.S. Government Accountability Office:
441 G. Street N.W.:
Washington, D.C. 20548:
Dear Ms. Mittal:
Thank you for the opportunity to comment on the GAO's proposed report
on Federally supported nanotechnology-related environmental, health,
and safety research (GAO-08- 402).
Generally, the Office of Science and Technology Policy (OSTP) agrees
with the report's findings and is pleased that the GAO found
interagency coordination and prioritization of nanotechnology EHS
research to be effective and reasonable. OSTP is particularly pleased
that the GAO noted one of the strengths of the government's interagency
coordination lies in the knowledgeable and dedicated Federal employees
that work in this area.
With respect to GAO's finding that a fraction of NNI-identified EHS
research projects is not primarily focused on EHS risks, OSTP
acknowledges that this budget cross-cut is open to reasonable,
different interpretations. These illustrate the challenges associated
with attempting to categorize fundamental, knowledge-creating research
and to determine to what degree such research is related to EHS.
Nonetheless, while GAO's presumption in the process recommendation”that
more accurate reporting will better support program planning and policy
development”is correct in principle, it does not follow that marginal
differences in individual agency reporting negatively affect
interagency coordination and prioritization or agency-level
implementation of nanotechnology EHS research. This is borne out by
GAO's own findings in this report.
OSTP, the Office of Management and Budget (OMB), and the National
Nanotechnology Coordinating Office (NNCO) already provide extensive
detailed guidance for reporting nanotechnology research, particularly
for EHS”more guidance, in fact, than perhaps any other area of
Federally-funded research and development. This guidance is based
directly on program component area designations established in the
National Nanotechnology Initiative Strategic Plan by the interagency
Subcommittee on Nanoscale Science, Engineering, and Technology (NSET)
of the National Science and Technology Council. As with all agency
reporting, we fundamentally rely on the expert judgment of the program
managers at the agency level.
In the aggregate, the data that are currently reported provide
sufficient and clear perspective and are just one of many key inputs to
guide coordination, program planning and future directions. Therefore,
OSTP does not agree that more detailed reporting guidance will result
in better coordination of nanotechnology EHS research. However, given
the GAO's findings, OSTP will discuss the manner in which agencies
respond to current guidance at future NSET meetings.
Thank you for the opportunity to comment. OSTP appreciates GAO's
efforts to fully understand the NNI and NSET interagency coordination
process, and generally agrees with the report's overall assessments.
Sincerely,
Signed by:
John H. Marburger, III:
Director:
[End of section]
Appendix II Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office of the Assistant Secretary for Legislation:
Washington, D.C. 20201:
February 29, 2008:
Ms. Anu Mittal:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Ms. Mittal:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: Nanotechnology:
Better Guidance Is Needed to Ensure Accurate Reporting of Federal
Research Focused on Environmental, Health, and Safety Risks (GAO 08-
402).
The Department appreciates the opportunity to review and comment on
this draft report before its publication.
Sincerely,
Jennifer R. Luong:
for:
Vince Ventimiglia:
Assistant Secretary for Legislation:
General Comments Of The U.S. Department Of Health And Human Services
(HHS) On The U.S. Government Accountability Office's Draft (GAO) Draft
Report Entitled: "Nanotechnology: Better Guidance Is Needed To Ensure
Accurate Reporting Of Federal Research Focused On Environmental,
Health, And Safety Risks "(GAO-08-402):
The report clearly addresses the three charges that GAO was given, but
in finding that there were some misclassifications of "applications"
projects as "implications," the report could have focused more on the
adequacy of funding for research on environmental and occupational
health and safety implications. Additionally, the report does not
distinguish funding derived from NNI allocations and funding resulting
if an agency reprograms non NNI internal funds.
The report does not discuss the activities of OSHA regarding
occupational health risks.
[End of section]
Appendix III: Comments from the National Institute of Standards and
Technology:
United States Department Of Commerce:
National Institute of Standards and Technology:
Gaithersburg, Maryland 20899-0001:
Office Of The Director:
February 21, 2008:
Memorandum For: Anu Mittal:
Director, Natural Resources and Environment:
Government Accountability Office:
From: Signed by: James M. Turner, Ph.D.:
Acting Director:
Subject - Comments on Government Accountability Office (GAO) Draft
Report Entitled "Nanotechnology: Better Guidance is Needed to Ensure
Accurate Reporting of Federal Research Focused on Environmental,
Health, and Safety Risks" (GAO-08-402):
This is in response to your draft report dated March 2008 entitled
"Nanotechnology: Better Guidance is Needed to Ensure Accurate Reporting
of Federal Research Focused on Environmental, Health, and Safety
Risks." Thank you for the opportunity to review and comment on this
draft.
Overall, the draft report is fair and balanced. The report does not,
however, explicitly incorporate changes requested by the National
Institute of Standards and Technology (NIST) to elucidate the
relatively large size of nanotechnology Environmental Health and Safety
(EHS) - enabling NIST research compared to the small size of explicitly
nanotechnology EHS - focused Program Component Area (PCA) 7A research.
The report accurately notes that "Some agencies conduct research that
results in information highly relevant to EHS risks but that this
research was not primarily directed at understanding, or addressing,
those risks and therefore is not captured in the EHS total." Further,
the report gives two detailed examples of research resulting in
information highly relevant to EHS risks, and included NIST in these
examples. I appreciate the recognition of this situation and agree with
the findings. I am committed to ensuring that NIST continues to provide
technically sound and timely standards support to the National
Nanotechnology Initiative (NNI).
We are looking forward to receiving your final report. Please contact
Steve Willett on (301) 975-8707 should you have any questions regarding
this response.
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
Anu Mittal, 202-512-3841 or mittala@gao.gov:
Staff Acknowledgments:
In addition to the contact person named above, Cheryl Williams
(Assistant Director), Nancy Crothers, Elizabeth Erdmann, David Lutter,
and Rebecca Shea made key contributions to this report.
[End of section]
Footnotes:
[1] The creation of the NNI formalized an existing interagency dialogue
on nanotechnology that began in 1998.
[2] For purposes of this report we use the term "research agency" to
mean an agency whose primary mission is to conduct or facilitate
scientific research, and the term "regulatory agency" to mean an agency
whose primary mission is to administer regulatory programs related to
environment, human health, and safety, and which may have a role in
regulating products containing nanomaterials. A small number of
agencies carry out both functions; we will refer to these by their
primary mission.
[3] As of December 2007, a total of four working groups exist within
the NSET subcommittee: (1) Global Issues in Nanotechnology; (2)
Nanotechnology Environmental and Health Implications; (3)
Nanomanufacturing, Industry Liaison, and Innovation; and (4)
Nanotechnology Public Engagement and Communications.
[4] Pub. L. No. 108-153 (2003).
[5] The nine grand challenges were as follows: nanostructured materials
by design; manufacturing at the nanoscale; chemical-biological-
radiological-explosive detection, and protection; nanoscale
instrumentation and metrology; nano-electronics, -photonics, and -
magnetics; healthcare, therapeutics, and diagnostics; efficient energy
conversion and storage; microcraft and robotics; and nanoscale
processes for environmental improvement.
[6] The NNI's four goals are to (1) maintain a world-class research and
development program aimed at realizing the full potential of
nanotechnology; (2) facilitate transfer of new technologies into
products for economic growth, jobs, and other public benefit; (3)
develop educational resources, a skilled workforce, and the supporting
infrastructure and tools to advance nanotechnology; and (4) support
responsible development of nanotechnology.
[7] The seven program component areas are fundamental nanoscale
phenomena and processes; nanomaterials; nanoscale devices and systems;
instrumentation research, metrology, and standards for nanotechnology;
nanomanufacturing; major research facilities and instrumentation
acquisition; and societal dimensions.
[8] NSTC, Committee on Technology, Subcommittee on Nanoscale Science,
Engineering, and Technology, "Environmental, Health, and Safety
Research Needs for Engineered Nanoscale Materials," Sept. 20, 2006.
[9] The Health and Environmental Exposure Assessment category was
initially named Health and Environmental Surveillance.
[10] NSTC, Committee on Technology, Subcommittee on Nanoscale Science,
Engineering, and Technology, NEHI Working Group, "Prioritization of
Environmental, Health, and Safety Research Needs for Engineered
Nanoscale Materials: An Interim Document for Public Comment," Aug. 16,
2007.
[11] The five specific needs for the Nanomaterials and Human Health
category were all afforded the same top priority.
[12] The Nanotechnology Characterization Laboratory is part of NIH's
National Cancer Institute.
[13] GAO, Results-Oriented Government: Practices That Can Help Enhance
and Sustain Collaboration among Federal Agencies, GAO-06-15
(Washington, D.C.: Oct. 21, 2005).
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441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548:
