Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.

To help guide research, the Committee noted the following four research categories, which it states should be addressed within five years:

• Identify and quantify the nanomaterials being released and the populations and environments being exposed;
• Understand processes that affect both potential hazards and exposure;
• Examine nanomaterial interactions in complex systems ranging from subcellular to ecosystems; and
• Support an adaptive research and knowledge infrastructure for accelerating progress and providing rapid feedback to advance research.

The Committee acknowledged a gap between funding and the level of activity required to support its strategy. The Committee concluded that any reduction in the current funding level of approximately $120 million per year over the next five years for health and environmental risk research by federal agencies would be a setback to nanomaterials risk research. Moreover, according to the Committee, additional “modest resources” from public, private, and international initiatives are needed in critical areas -- informatics, nanomaterial characterization, benchmarking nanomaterials, characterization of sources, and development of networks for supporting collaborative research -- to derive maximum strategic value from the research investments.

The Committee states that implementation of the strategy should also include the integration of domestic and international participants involved in nanotechnology-related research, including the National Nanotechnology Initiative (NNI), federal agencies, the private sector, non-governmental organizations, and the academic community. The Committee noted that the current structure of the NNI, which has no top-down budgetary or management authority to direct nanotechnology-related EHS research, hinders its accountability for effective implementation. In addition, according to the Committee, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. The Committee concluded that, to carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential.

 

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The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group, will serve as the moderator. Panelists will include:

• Dr. Treye Thomas, NEHI Working Group Co-Chair;
• Dr. Shaun Clancy, Evonik DeGussa Corporation;
• Dr. Janet Carter, Occupational Safety and Health Administration (OSHA); and
• Lynn L. Bergeson, Bergeson & Campbell, P.C.

The webinar will include a 20-minute question-and-answer segment following the presentations.

 

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On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. According to NNI, the workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that “knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy.”

Through four separate workshops, experts examined the following areas:

• Nanomaterials and Human Health and Instrumentation, Metrology, and Analytics;
• Nanomaterials and the Environment and Instrumentation, Metrology, and Analytics;
• Human and Environmental Exposure Assessment; and
• Risk Management Methods and Ethical, Legal, and Societal Implications of Nanotechnology.

 

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The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy (Strategy). The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision.  It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision.  It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods) and evaluates the state of the science for each of these topics.  The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area.  The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.

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On July 1, 2010, the NanoBusiness Alliance issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.” The NanoBusiness Alliance is committed to working with governments and nanomaterials stakeholders to manage the sustainable development and use of nanomaterials in a responsible way. The Position Statement states:

As an enabling technology applicable to diverse fields, including alternative energy, medicine, and electronics, among many others, nanotechnology offers tremendous value to society. As with any emerging technology, nanotechnology and nanoscale materials must be managed in a responsible way to identify and minimize any potential adverse effect on human health or the environment. The Alliance is committed to fostering the responsible and sustainable development of nanotechnology, to working with governmental and related nanotechnology stakeholders to develop appropriate scientific testing tools, methodologies, and data to characterize nanoscale materials, and to developing informed, science-based governance policies, laws, standards, practices, and regulations pertinent to nanoscale materials.

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On May 28, 2010, the House passed, by a vote of 262-150, the America COMPETES Reauthorization Act of 2010 (H.R. 5116), which would authorize funding for the National Nanotechnology Initiative (NNI), as well as the National Science Foundation (NSF), National Institute of Standards and Technology (NIST), and Department of Energy (DOE) Office of Science activities. The bill includes language from H.R. 554, the NNI Amendments Act of 2009, which the House passed in February 2009. H.R. 5116 would require NNI to work toward developing “standards related to methods and procedures for detecting, measuring, monitoring, sampling, and testing engineered nanoscale materials for environmental, health, and safety impacts.” The bill would fund research on “green nanotechnology” by creating research centers that would focus on methods and approaches to develop environmentally benign nanoscale products and nanoscale manufacturing processes; foster the transfer of the results of such research to industry; and provide for the education of scientists and engineers through interdisciplinary studies in the principles and techniques for the design and development of environmentally benign nanoscale products and processes. The bill would create a position, within the Office of Science and Technology Policy (OSTP), for a Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would ensure that a research plan for the environmental, health, and safety (EHS) research activities is developed, updated, and implemented.

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We are pleased to announce that Lynn L. Bergeson is included in the Nanotechnology Law & Business list of the top ten experts in environmental, health, and safety (EHS) issues related to engineered nanomaterials. Nanotechnology Law & Business states that they chose ten individuals with “substantial expertise” in EHS issues related to engineered nanomaterials and that they “expect these individuals to play leading roles in nanotechnology law and business.” Nanotechnology Law & Business is a peer-reviewed journal devoted to the legal, business, and policy aspects of small scale technologies.

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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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In its latest Background Paper, entitled Mounting Evidence That Carbon Nanotubes May Be the New Asbestos, Friends of the Earth Australia (FOEA) is calling “for an immediate moratorium on the commercial use of carbon nanotubes and the sale of products that incorporate nanotubes until research can demonstrate whether or not there is any safe level of exposure to them.”   FOEA also is calling for new nanotechnology-specific regulation to protect human health and the environment, as well as for mandatory labeling of all nanoscale materials used in the workplace and in consumer products.

FOEA’s paper summarizes various studies that have been conducted on carbon nanotubes and contends that these studies suggest “strongly that some forms of nanotubes could pose similar health risks to asbestos and that a wide range of nanotubes cause both localised and system toxic effects.” FOEA argues that suitable detection technologies to measure occupational exposure levels to nanotubes do not exist, and it decries the fact that material safety data sheets for carbon nanotubes “remain based on synthetic graphite.”

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On July 28, 2008, the City Council of Cambridge, Massachusetts voted to accept a set of recommendations for a municipal health and safety policy on nanomaterials. The recommendations were set forth in a report prepared by the Cambridge Public Health Department (CPHD) and the Cambridge Nanomaterials Advisory Committee (CNAC). Cambridge now becomes the second city in the United States -- Berkeley, California is the other -- to have taken municipal action on nanomaterials.

The Berkeley City Council approved an ordinance in December 2006 that imposed a reporting obligation on facilities manufacturing or using nanomaterials. Shortly thereafter, the Cambridge City Council directed the City Manager to examine the Berkeley ordinance and recommend an appropriate municipal ordinance for Cambridge. The City Manager convened the CNAC and charged it with developing recommendations for oversight of local nanotechnology activities to protect human health. CNAC proceeded to develop a number of recommendations, all of which were endorsed by CPHD and have now been accepted by the City Council.

The recommendations call for Cambridge to take the following steps:

• Establish an inventory of facilities that manufacture, process, handle, or store engineered nanoscale materials;
• Offer technical assistance to help firms and institutions evaluate their existing health and safety plans;
• Offer up-to-date health information to residents on products containing nanomaterials;
• Track rapidly changing developments in research;
• Track the evolving status of regulations and best practices concerning engineered nanoscale materials; and
• Report back to the City Council every other year on the changing regulatory and safety landscape.

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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 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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On November 19, 2007, the Congressional Nanotechnology Caucus held a briefing on “Nanotechnology and Environment, Health & Safety Issues.” The panel of speakers included Vicki Colvin, Ph.D., Professor of Chemistry and Chemical Engineering, Center for Biological and Environmental Nanotechnology, Rice University; Andrew Maynard, Ph.D., Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars; and Pat Casano, Counsel for Environmental, Legislative, and Regulatory Affairs, General Electric. The panel discussed the environmental, health, and safety (EH&S) implications of nanotechnology.

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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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