GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research

Posted on April 29, 2008 by Lynn L. Bergeson

On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research.

According to NNI, in FY 2006, federal agencies devoted $37.7 million -- or three percent of the $1.3 billion total nanotechnology research funding -- to research primarily focused on the EHS risks of nanotechnology, according to the NNI. GAO found that about 20 percent of this total could not actually be attributed to this purpose, however. GAO states that 22 of the 119 projects identified as EHS in FY 2006 were not primarily related to understanding the extent to which nanotechnology may pose an EHS risk. Instead, many of the projects focused on how to use nanotechnology to remediate environmental damage or detect hazards not related to nanotechnology. GAO states that, at the time of its review, federal agencies and NNI were in the process of identifying and prioritizing EHS risk research needs, and the overall process they were using appeared reasonable. NNI also was engaged in an iterative prioritization effort through its Nanotechnology Environmental and Health Implications (NEHI) working group. NEHI identified five general research categories as a priority for federally funded research. GAO found that most of the research projects that were underway in FY 2006 were generally consistent with agency and NEHI priorities. NEHI released its new EHS research strategy on February 13, 2008. According to GAO, agency and NNI processes to coordinate activities related to potential EHS risks of nanotechnology have been generally effective. In its March 2008 report, GAO recommended better guidance to improve the accuracy of data reported by NNI. Although the Office of Science and Technology Policy (OSTP) asserted that it provides extensive guidance, it agreed to review how the agencies respond to the current guidance. Robinson made no new recommendations in his statement before the Subcommittee.
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NSET Releases Strategy for Nanotechnology-Related EHS Research

Posted on February 21, 2008 by Lynn L. Bergeson

On February 14, 2008, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology released a final document entitled Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, which describes the National Nanotechnology Initiative’s (NNI) strategy for addressing priority research on the environment, health, and safety (EHS) aspects of nanomaterials. The NNI EHS Strategy assigns priority to research and information needs identified by the NSET Subcommittee. NNI released an interim version of the EHS Strategy in August 2007, entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment. NNI incorporated public comments in preparing the final EHS Strategy. The Nanotechnology Environmental and Health Implications (NEHI) Working Group developed the EHS Strategy “to accelerate progress in research to protect public health and the environment, and to fill gaps in, and -- with the growing level of effort worldwide -- to avoid unnecessary duplication of, such research.”

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CRS Report Reviews Possible Risk Management Approaches for Congress to Consider

Posted on February 6, 2008 by Lynn L. Bergeson

According to a January 22, 2008, Congressional Research Service (CRS) report entitled Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, questions about the need for, and ideal form of, nanotechnology regulations are “exceedingly difficult” to address, given the current state of scientific understanding. CRS considered challenges faced by scientists, entrepreneurs, and agency officials involved in the National Nanotechnology Program as they work to define the characteristics of nanomaterials; the environmental, human health, and safety (EHS) risks they might pose; and how any potential risks should be addressed. The report states that challenges include the wide variety of nanomaterials and applications; lack of basic information about their properties; lack of conventions for naming, measuring, and identifying nanomaterials; the proprietary nature of some critical information; the need to prioritize federal resource needs; and a possible lack of clear statutory authority or appropriate regulatory framework to anticipate or respond to any identified risks. CRS states that, should Congress choose to intervene, it might choose any of several approaches: increasing funding for workshops in standardization or other research relevant to identifying and possibly ameliorating any EHS concerns associated with nanomaterials; changing the allocation of research money among agencies or the interagency research management structure; adopting a national or international research strategy; or enacting legislation that authorizes, mandates, or constrains agency actions to require information collection or to restrict production, sale, use, or disposal of nanomaterials.

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DEFRA Publishes Research Report On Manufactured Nanomaterials

Posted on December 26, 2007 by Lynn L. Bergeson

On December 19, 2007, the Department for Environment, Food and Rural Affairs (DEFRA) published a report entitled Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report, which follows up on DEFRA’s 2005 report and 2006 progress report. The report reviews the status of research pertaining to the environmental, health, and safety (EHS) issues relating to engineered nanoparticles, and places the United Kingdom’s (UK) research program in an international context. DEFRA is collaborating with international partners, particularly the Organization for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO), to share data and experiences. In this way, according to the report, DEFRA will be able to maximize the effectiveness and speed with which potential risks may be identified and managed.

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EHS Research Priorities Released for Comment

Posted on August 21, 2007 by Lynn L. Bergeson

On August 16, 2007, the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007.

The document identifies 25 priority research needs across five research categories.  The needs are listed from highest to lowest priority for each category, with the exception of those presented in the category Nanomaterials and Human Health.  The Nanomaterials and Human Health Task Force gave equal weight to identified research needs under an overarching research priority for the category.

Research Category:  Instrumentation, Metrology, and Analytical Methods

  1. Develop methods to detect nanomaterials in biological matrices, the environment, and the workplace.
  2. Understand how chemical and physical modifications affect the properties of nanomaterials.
  3. Develop methods for standardizing assessment of particle size, size distribution, shape, structure, and surface area.
  4. Develop certified reference materials for chemical and physical characterization of nanomaterials.
  5. Develop methods to characterize a nanomaterial’s spatio-chemical composition, purity, and heterogeneity.

Research Category:  Nanomaterials and Human Health

Overarching Research Priority:  Understand generalizable characteristics of nanomaterials in relation to toxicity in biological systems.

Broad Research Needs:

  • Develop methods to quantify and characterize exposure to nanomaterials and characterize nanomaterials in biological matrices.
  • Understand the absorption and transport of nanomaterials throughout the human body.
  • 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.
  • Determine the mechanisms of interaction between nanomaterials and the body at the molecular, cellular, and tissular levels.
  • Identify or develop appropriate in vitro and in vivo assays/models to predict in vivo human responses to nanomaterials exposure.

Research Category:  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.
  2. Understand environmental exposures through identification of principle sources of exposure and exposure routes.
  3. Evaluate abiotic and ecosystem-wide effects.
  4. Determine factors affecting the environmental transport of nanomaterials.
  5. Understand the transformation of nanomaterials under different environmental conditions.

Research Category:  Health and Environmental Exposure Assessment

  1. Characterize exposures among workers.
  2. Identify population groups and environments exposed to engineered nanoscale materials.
  3. Characterize exposure to the general population from industrial processes and industrial and consumer products containing nanomaterials.
  4. Characterize health of exposed populations and environments.
  5. Understand workplace processes and factors that determine exposure to nanomaterials.

Research Category:  Risk Management Methods

Overarching Research Priority:  Evaluate the appropriateness and effectiveness of current and emerging risk management approaches for identifying those nanomaterials with the greatest potential risks.

Broad Research Needs:

  1. Understand and develop best workplace practices, processes, and environmental exposure controls.
  2. Examine product or material life cycle to inform risk reduction decisions.
  3. Develop risk characterization information to determine and classify nanomaterials based on physical or chemical properties.
  4. Develop nanomaterial-use and safety-incident trend information to help focus risk management efforts.
  5. Develop specific risk communication approaches and materials.

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Senate Requests GAO Review of NNI

Posted on March 22, 2007 by Lynn L. Bergeson

In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

To determine the extent to which federal agencies have undertaken EHS research and how they are prioritizing and managing this research, the Committee and Caucus ask GAO to:

  •  Review the extent to which NNI-related resources have been devoted to study the EHS risks of nanomaterials;
  • Identify the key areas of research for which this EHS funding has been used;
  • Determine what processes the Nanotechnology Environmental and Health Implications Working Group uses to prioritize and coordinate these various EHS research efforts; and
  • Review and identify any EHS-related research and regulatory activities, independent of the NNI, that EPA, FDA, CPCS, and OSHA have undertaken, the amount of funding made available for these efforts, and the extent to which information about these efforts has been communicated to the Working Group to ensure that they are considered in the overall research planning processes for the NNI.

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