On November 7, 2012, the National Institute for Occupational Safety and Health (NIOSH) Nanotechnology Research Center (NTRC) posted a document entitled Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace: A Progress Report from the NIOSH Nanotechnology Research Center, 2004–2011. NIOSH established NTRC in 2004 to address occupational safety and health concerns associated with nanotechnology. The progress report summarizes program accomplishments from the inception of NTRC in 2004 through 2011. It includes an analysis of the progress made toward accomplishing the goals and objectives of the NIOSH Strategic Plan for Nanotechnology Research and toward addressing the goals and research needs identified in the National Nanotechnology Initiative (NNI) environmental, health, and safety (EHS) research strategy. The progress report states that NTRC “continues to support and promote the responsible development of nanotechnology through its ongoing research program and its contributions to the development of guidelines for hazard identification, exposure assessment, and risk characterization that can be used to develop and implement effective risk management practices.”
The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion. Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead “may not be as large as it was for previous emerging technologies.” According to CRS, some research has raised concerns about the safety of nanoscale materials, and “[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation.”
NRC Publishes A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials
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.
ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade. ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS. ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field. According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.
ObservatoryNANO identified and grouped key organizations and projects into seven major areas:
- Knowledge Transfer and Review;
- Public Engagement; and
- Professional Bodies.
The landscaping document provides a short overview of the organizations working within each area, together with links and references to further information.
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.
The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:
- Significant discussion about environmental, health, and safety (EHS) questions for nanotechnology-enabled products;
- Hands-on participation in joint programs of work that will better leverage resources; and
- Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.
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.
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.
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.
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.
Lynn L. Bergeson Included in List of Top Ten Experts in EHS Issues Related to Engineered Nanomaterials
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.
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.
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.
GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research
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
- Develop methods to detect nanomaterials in biological matrices, the environment, and the workplace.
- Understand how chemical and physical modifications affect the properties of nanomaterials.
- Develop methods for standardizing assessment of particle size, size distribution, shape, structure, and surface area.
- Develop certified reference materials for chemical and physical characterization of nanomaterials.
- 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
- Understand the effects of engineered nanomaterials in individuals of a species and the applicability of testing schemes to measure effects.
- Understand environmental exposures through identification of principle sources of exposure and exposure routes.
- Evaluate abiotic and ecosystem-wide effects.
- Determine factors affecting the environmental transport of nanomaterials.
- Understand the transformation of nanomaterials under different environmental conditions.
Research Category: Health and Environmental Exposure Assessment
- Characterize exposures among workers.
- Identify population groups and environments exposed to engineered nanoscale materials.
- Characterize exposure to the general population from industrial processes and industrial and consumer products containing nanomaterials.
- Characterize health of exposed populations and environments.
- 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:
- Understand and develop best workplace practices, processes, and environmental exposure controls.
- Examine product or material life cycle to inform risk reduction decisions.
- Develop risk characterization information to determine and classify nanomaterials based on physical or chemical properties.
- Develop nanomaterial-use and safety-incident trend information to help focus risk management efforts.
- Develop specific risk communication approaches and materials.
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.