Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks
Published: 2008-03-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Nanotechnology encompasses a wide range of innovations based on the  Nanotechnology encompasses a wide range of innovations based on the  understanding and control of matter at the scale of nanometers—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  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  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  wide, and 2 gold atoms lying side by side are about 1 nanometer long. At  the nanoscale level, some materials may exhibit electrical, magnetic,  the nanoscale level, some materials may exhibit electrical, magnetic,  biological, and other properties that differ significantly from properties the  biological, and other properties that differ significantly from properties the  same materials exhibit at a larger scale. For example, opaque materials,  same materials exhibit at a larger scale. For example, opaque materials,  such as copper, become transparent at the nanoscale and inert materials,  such as copper, become transparent at the nanoscale and inert materials,  such as platinum and gold, become chemical catalysts. Exploiting the  such as platinum and gold, become chemical catalysts. Exploiting the  differences in the size and properties of materials at the nanoscale level  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  has led to a range of commercial uses and holds the promise for  innovations in virtually every industry from aerospace and energy to  innovations in virtually every industry from aerospace and energy to  health care and agriculture. In 2006, an estimated $50 billion in products  health care and agriculture. In 2006, an estimated $50 billion in products  worldwide incorporated nanotechnology and this figure has been  worldwide incorporated nanotechnology and this figure has been  projected to grow to $2.6 trillion by 2014, according to an industry analyst.  projected to grow to $2.6 trillion by 2014, according to an industry analyst.  The Woodrow Wilson International Center for Scholars’ Project on  The Woodrow Wilson International Center for Scholars’ Project on  Emerging Nanotechnologies has identified over 500 consumer products  Emerging Nanotechnologies has identified over 500 consumer products  that already are available to consumers that may contain nanoscale  that already are available to consumers that may contain nanoscale  materials. For example, nanoscale materials have been embedded into  materials. For example, nanoscale materials have been embedded into  clothing fabric to repel stains. Some nanoscale materials in development  clothing fabric to repel stains. Some nanoscale materials in development  could greatly improve pharmaceuticals because the materials’ size,  could greatly improve pharmaceuticals because the materials’ size,  structure, and behavior can be used, for example, to treat diseases by  structure, and behavior can be used, for example, to treat diseases by  delivering drugs directly to affected cells, such as tumor cells. Food  delivering drugs directly to affected cells, such as tumor cells. Food  companies also are experimenting with nanoscale materials that can be  companies also are experimenting with nanoscale materials that can be  incorporated into food packaging to detect spoilage or pathogens, and  incorporated into food packaging to detect spoilage or pathogens, and  cosmetics companies have developed products with nanoscale materials  cosmetics companies have developed products with nanoscale materials  that reportedly enable sunscreens to perform better.  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. 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. 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. 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. 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.
subsections: section_title: Background
paragraphs: 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.
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.
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.
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. 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.  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. 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.
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.
section_title: Almost 20 Percent of EHS Research Projects Were Not Primarily Focused on Studying the EHS Risks of Nanotechnology
paragraphs: 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.
subsections: section_title: EHS Research Constituted about 3 Percent of Federal Nanotechnology Research Funding in Fiscal Year 2006
paragraphs: 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.
section_title: Current Reporting Structure and Limited Guidance Contribute to Inaccurate Reporting of EHS Risk Research
paragraphs: 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.
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.
section_title: Agencies Conduct Additional Research that Also Helps Advance Scientific Knowledge of Potential EHS Risks
paragraphs: 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.
section_title: Processes to Identify and Prioritize Needed EHS Research Appear Reasonable and Are Ongoing but a Comprehensive Research Strategy Has Not Yet Been Developed
paragraphs: 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.
subsections: section_title: Agencies Have Identified Their EHS Research Priorities
paragraphs: 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.
section_title: NNI’s Efforts to Prioritize Research Needs Are Ongoing
paragraphs: 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. 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. Second, following efforts to obtain public  input on its 2006 report, NEHI released another report in August 2007, in  which it distilled the previous list of 75 unprioritized specific research  needs into a set of five prioritized needs for each of the five general  research categories.
The NEHI working group has used these initial steps to identify the gaps  between the needs and priorities it has identified and the research that  agencies have underway. 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.
section_title: Agencies’ and the NNI’s Prioritization Processes Appear Reasonable
paragraphs: 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.
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.
section_title: Coordination Processes Have Fostered Interagency Collaboration and Information-Sharing
paragraphs: 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. 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.
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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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 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.
section_title: Appendix I: Comments from the Office of Science and Technology Policy
section_title: Appendix II: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.