Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

In an August 7, 2009, letter to the White House Office of Science Technology and Policy (OSTP), the Environmental Council of the States (ECOS) expressed its interest in working with OSTP and other federal agencies regarding the “human health and ecological impacts and lifecycle consequences of intentional and unintentional releases of engineered nanoparticles into the environment.” According to ECOS, state environmental agencies want to participate in national efforts to develop best assessment and management practices. ECOS suggests that one option is for ECOS to join one or more of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee Working Groups within the National Nanotechnology Initiative (NNI) framework. ECOS asked OSTP for a meeting, “preferably this summer,” to obtain feedback on its key areas of interest and to discuss the best opportunities for its involvement in national efforts.

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On February 13, 2009, the National Nanotechnology Coordination Office (NNCO) released a statement regarding the National Research Council’s (NRC) December 10, 2008, report regarding its review of the National Nanotechnology Initiative (NNI) Strategy for Nanotechnology-Related Environmental, Health, and Safety (EHS) Research.  According to the statement, NNI member agencies noted the report’s “substantial and important recommendations for further progress on EHS research,” and “look forward to working with the NRC on achieving the vital and shared goals of clearly, proactively assessing the potential benefits and risks that may be associated with specific nanomaterials in specific applications.”  NNCO notes that it “do[es] not believe that the NRC evaluation recognized the breadth and depth of the NNI commitment to EHS research. . . .  Furthermore, the report drew a number of conclusions with which the NNI member agencies respectfully disagree.” NNCO provided detailed comments to the NRC in a January 5, 2009, letter. On February 24-25, 2009, NNCO held a workshop regarding the science related to EHS aspects of engineered nanoscale materials in the area of human and environmental exposure assessment, one of the five EHS research categories identified in the Strategy for Nanotechnology-Related Environmental, Health, and Safety Research.

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On January 15, 2009, Representative Bart Gordon (D-TN), Chair of the House Science Committee, introduced the National Nanotechnology Initiative (NNI) Amendments Act of 2009 (H.R. 554). The bill is identical to H.R. 5940, which passed the House in the previous Congress with a 407-6 vote. The legislation would reauthorize the multi-agency research program that Congress established in 2003 through the 21st Century Nanotechnology Research and Development Act of 2003 (Pub. Law 108-153). Under the Act, federal agencies would be required to develop a research plan and implementation strategy that specifies near- and long-term goals, sets milestones and time frames for meeting near-term goals, clarifies agencies’ roles in implementing the plan, and allocates sufficient resources to accomplish those goals. The bill would authorize funding for research in areas of national need, such as research to develop renewable energy and batteries that could store energy more efficiently, and would direct agencies to take steps to help private companies commercialize nanotechnology applications.

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On July 17, 2007, Senators Daniel K. Inouye (D-HI), Chair of the Commerce, Science, and Transportation Committee, John Kerry (D-MA), Olympia Snowe (R-ME), Ted Stevens (R-AK), Mark Pryor (D-AR) and Gordon Smith (R-OR) introduced the National Nanotechnology Initiative Amendments Act of 2008. The bill would reauthorize the National Nanotechnology Initiative (NNI) and amend aspects of the program to prioritize better research and development activities.

Specifically, the bill would:

• Establish the National Nanotechnology Advisory Panel, which would be responsible for recommending an appropriate funding level for the environmental, health, and safety (EHS) program component area. The bill would also establish a subpanel focused on the societal, ethical, legal, environmental, and workforce issues related to nanotechnology;
• Provide consistent funding for the National Nanotechnology Coordination Office (NNCO) through the participating federal agencies;
• Require the NNCO to establish a publicly available database of the projects funded in the EHS program component area, the educational and societal dimensions program component area, and the nanomanufacturing program component area;
• Require an Office of Science and Technology Policy official to serve as the Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would be required to develop and annually update a research plan for the EHS program component area;
• Support the development of standards, metrology, and characterization tools for nanotechnology;
• Promote technology transfer through the Small Business Innovation Research Program and the Small Business Technology Transfer Program, and make federally funded nanotechnology facilities available to companies to assist in the development of prototypes of nanoscale products, devices, or processes;
• Promote nanotechnology research and development in areas of national importance, including nano-electronics, energy efficiency, health care, water remediation, instrumentation and characterization, and rapid production nanomanufacturing;
• Require the Government Accountability Office to conduct a comprehensive study of federal codes, standards, and regulations as they relate to the safe production, use, and disposal of engineered nanomaterials and products containing nanomaterials; and
• Require the NNCO to engage the public by convening a national discussion on nanotechnology. This national discussion would include diverse participation and incorporate the views of academia, nongovernmental organizations, and industry to identify priorities and concerns related to nanotechnology research and development, products, and regulatory policy.

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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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On April 24, 2008, the Senate Committee on Commerce, Science, and Transportation will hold a hearing entitled “National Nanotechnology Initiative: Charting the Course for Reauthorization.” The National Nanotechnology Initiative (NNI) currently receives approximately $1.5 billion. The hearing will examine the five-year period since the NNI was initially authorized in 2003 and explore issues the Committee should consider for the next reauthorization.  

Witnesses scheduled to speak at the hearing include:

• Panel 1

• The Honorable Richard M. Russell
  Associate Director and Deputy Director for Technology
  Executive Office of the President 
• Mr. Robert A. Robinson
  Managing Director, Natural Resources and Environment Team
  U.S. Government Accountability Office

• Panel 2

• Mr. Matthew M. Nordan
  President
  Lux Research Incorporated 
• Mr. David Rejeski
  Director, Foresight and Governance Project and Project on Emerging Nanotechnologies
  Woodrow Wilson Center  
• Dr. P. Lee Ferguson
  Assistant Professor, Department of Chemistry and Biochemistry
  University of South Carolina 
• Dr. Anita Goel
  Nanobiosym Incorporated
• Dr. Jim Heath
  Director
  NSB Cancer Center

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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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On January 2, 2008, the National Nanotechnology Initiative (NNI) released its Strategic Plan, which describes NNI’s investment strategy and the program component areas called for by the 21st Century Nanotechnology Research and Development Act of 2003. Under the Act, NNI must update its Strategic Plan every three years, and this plan updates and replaces the December 2004 plan. The Strategic Plan outlines the goals and priorities of NNI and describes approaches for achieving them. NNI states that the Plan supports “leading edge research, sustains the extensive infrastructure of facilities, seeks to facilitate technology transfer, and addresses environmental, health, and societal concerns.”

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On November 19, 2007, Environmental Defense (ED) issued a press release that states that the National Nanotechnology Initiative (NNI) is not effectively addressing the potential risks of nanotechnology, and that a potential model for resolving the conflict between NNI’s dual charges to both promote and oversee the technology could be drawn from the Atomic Energy Commission (AEC). Like the NNI, the AEC, first established in 1946, was tasked with both encouraging the development and use of nuclear power and regulating its safety. Concerns about this dual charge led Congress to abolish the AEC in 1975, and to assign its risk research and oversight functions to a new entity, the Nuclear Regulatory Commission. In the press release, ED suggests that an entity within NNI, “either newly formed or significantly elevated in status,” could be given independent budgetary and management authority, responsibility, accountability, and resources to develop and direct the overall federal nanomaterial risk research strategy.

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On October 31, 2007, the House Committee on Science and Technology’s Research and Science Education Subcommittee held a hearing on the relationship between environmental and health policy and nanotechnology. The Subcommittee examined how the U.S. can stay at the forefront of scientific research and development, while at the same time establishing priorities and a detailed plan for research on the potential environmental and health risks of engineered nanomaterials. The Science and Technology Committee held two previous hearings on this issue -- one in 2005 and another in 2006 -- with the objective of reviewing the importance of risk research for achieving the potential benefits of nanotechnology and the efforts of the interagency National Nanotechnology Initiative (NNI) to put in place a research strategy. Progress in developing the research strategy has been slow, however. The hearing explored the status of the planning efforts and received suggestions from outside witnesses on ways to improve the process.

Witnesses at the hearing included:

• Dr. Clayton Teague, Director of the National Nanotechnology Coordination Office;
• Mr. Floyd Kvamme, Co-Chair of the President’s Council of Advisors on Science and Technology;
• Dr. Vicki Colvin, Executive Director, International Council on Nanotechnology and Professor of Chemistry and Chemical Engineering, Rice University;
• Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars;
• Dr. Richard Denison, Senior Scientist, Environmental Defense; and
• Mr. Paul D. Ziegler, Chairman of the Nanotechnology Panel, American Chemistry Council.

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The National Nanotechnology Initiative (NNI) recently released a brochure entitled “Big Things from a Tiny World.” The brochure is intended for general readers rather than scientists, and describes what nanotechnology is, what nanotechnology-related products are available now, and the potential contributions of nanotechnology to address issues such as clean, renewable energy, clean water, and medical devices and drugs. The brochure also describes potential technological impacts and the research that is under way to identify those impacts.

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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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