The National Research Council (NRC) of the National Academies has been working for several years on the development of a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. On January 25th they released a draft of this strategy, which is available from the National Academies website. This work was commissioned by the Environmental Protection Agency. A coalition of nanotechnology stakeholders, including the NanoBCA, had encouraged additional study of how nano EHS issues are being addressed, and Congress authorized funds for the EPA to sponsor a four-year strategy study.
The study activities leading to the just-released report are directed by the NRC’s Board on Environmental Studies & Toxicology, with contributions from the Board on Chemical Sciences and Technology and the National Materials Advisory Board. A nineteen-person committee was selected to perform the study, chaired by Jonathan M. Samet, a pulmonary physician and epidemiologist from the University of Southern California who is an expert on the health risks of inhaled pollutants. You will see several familiar names on the full list of committee members which appears at the end of this newsletter. Some are members of the nanotechnology community who have participated in earlier Academies nanostudies or who lead major nanotechnology research efforts, while others represent the toxicology and environmental policy communities. The committee met five times between February 2010 and January 2011. The first two meetings included open sessions where they heard from a variety of experts, including our own EHS committee chair Lynn Bergeson.
The result of the committee’s deliberations so far is a suggested overall strategy for nanoEHS research which, the authors claim, would better focus research efforts to identify materials or products likely to cause harm and identify ways to mitigate that risk. The prioritization process would consider both a material’s level of hazard and the likelihood that human or environmental exposure to the material in a hazardous state would occur at some point in the full product lifecycle. They considered strategies and research needs catalogs that have already been developed by various national and international groups, as well as previous critiques of those strategies, but the report does not provide a detailed comparison to other current strategies. Much of the committee’s emphasis, especially in their analysis of available budgetary resources, is on EHS activities funded by U.S. agencies participating in the National Nanotechnology Initiative. But there are frequent mentions of the need for participation by a broad community of stakeholders, nationally and internationally, across academia, industry, government, and non-governmental organizations. The strategy appears to be addressed to all those stakeholders, though its boundaries are not clearly delineated.
Once the final version of the strategy document is released, the committee will move on to the second phase of the study. Phase 2 will consider the extent to which their recommendations have been implemented and will update those recommendations to reflect progress in nanoEHS research or significant changes in needs due to unforeseen developments. A report on that second and final phase is scheduled to be released in about 18 months.
The draft strategy released last week has generated a fair amount of attention, so let’s take a closer look at what the report actually says.
The report includes some broad statements in regard to gaps in our present knowledge and in existing research portfolios:
“First, little research progress has been made on some key topics, such as the effects of ingested ENMs [engineered nanomaterials] on human health. Second, there is little research on the potential health and environmental effects of the more complex ENMs that are expected to enter commerce over the next decade. Third, system-integrative approaches are needed that can address all forms of ENMs based on their properties and an understanding of the underlying biologic interactions that determine exposure and risk.”
We would like to propose a positive spin on the first point. Earlier EHS strategists were nearly unanimous in their expectation that the most likely danger to human health would come from inhalation of nanoparticles, with ingestion the least worrisome of the usual exposure routes. Apparently the committee is satisfied with progress that is being made on understanding inhalation and dermal exposure and believes the time has come to move on to ingestion. As for the second “criticism,” it is again encouraging that the committee feels that research capacity is sufficient to shift some efforts beyond simple materials already in commerce to more complex materials that are not yet widely used. This would seem to be a reasonable, orderly progression of the research agenda.
The committee’s own strategy is based on an integrated systems approach, directly addressing the third point. It emphasizes the use of risk management methods which consider the full lifecycle of both nanomaterials and products in which they are employed. While this strategy is explicitly addressed to EHS aspects of engineered nanomaterials rather than to of all of nanotechnology, its scope is broadened somewhat by layering a value chain analysis on top of the lifecycle analysis. To borrow an example from the report, to evaluate the potential impacts of the use of carbon nanotubes in bicycle frames, you would consider the hazards presented by a particular type of nanotube, the potential for exposure to the nanotubes during production of the frame, and the likelihood that any significant quantity of nanotubes will be released during the bicycle’s useful lifetime or when it is disposed of. They propose three risk properties that should be assessed for any given analysis: emergence, severity, and plausibility. Emergent risks would be risks which are unexpected from basic physical and chemical properties, unusually severe, or resistant to standard management methods – they emerge from the novel properties of the material at the nanoscale. The severity of a risk quantifies the “extent and magnitude of harm that might result” if the use of a nanomaterial was improperly managed. The plausibility of a risk is defined as the overall likelihood that a nanomaterial will pose human or environmental risks, incorporating hazard, exposure, and commercial viability. In the bicycle frame example, they point out that the plausibility of significant exposure during the use phase is low, while it is somewhat higher in the production phase and may rise again at end of life. (We would add that the emergent risk component is also not particularly high in this case, since standard workplace controls are known to be effective in controlling exposure to CNTs.)
In addition to developing a strategy, the committee was charged with estimating the resources needed for its implementation. This part of the report uses the historical investments made by the NNI agencies to benchmark financial resources, starting with $37.7 million in FY 2006 (the first year the NNI separately reported EHS investments) and growing to $123.5M requested in FY 2012. They assume a baseline NNI level of $120M per year for EHS over the next five years, and state that the “predominant challenge to closing the gap” between the current level of research activity and what they feel is required “is one of strategic realignment rather than additional funding.” They do, however, go on to propose new cross-cutting activities that could hasten progress in the field, with “modest” cost of $24M/yr, again for five years, to be spent as follows:
- Informatics: $5 million per year to support the development of robust informatics systems and tools for managing and using information on the EHS effects of ENMs.
- Instrumentation: $10 million per year to translate existing measurement and characterization techniques into platforms that are accessible and relevant to EHS research and to develop new EHS-specific measurement and characterization techniques for assessing ENMs under a variety of conditions.
- Materials: $3-5million per year to develop and distribute benchmark ENMs.
- Sources: $2 million per year to characterize sources of ENM release and exposure throughout the value chain and lifecycle of products.
- Networks: $2 million per year in new funding for the next 5 years should be invested in developing integrated researcher and stakeholder networks that facilitate the sharing of information and the translation of knowledge to effective use.
They explicitly recognize that these increased funding levels “are not likely to be met by the budget requests of any one agency or institute but need to be garnered through a coordinated effort on the part of the nanomaterial community to leverage additional resources from public, private, and international initiatives to support critical cross-cutting research.” This is an aspect of the report the NanoBCA community should consider carefully. The informatics, instrumentation, and materials proposals would seem particularly relevant to us and we should consider how we might facilitate them and ensure that their design is sensitive to the needs of industrial participants.
Equally important is what the report does not say. This report is about research, not regulation. It does not recommend new regulatory approaches for nanomaterials, nor does it suggest that regulatory agencies need to go beyond their current approaches to obtain needed information about individual nanomaterials. While it encourages the development of research protocols based on high throughput screening and predictive modeling, it makes no suggestion for how or when such protocols would be adopted for regulatory purposes. The report does not call for an expansion of the NNI definition of nanomaterials – it quite comfortably accepts the approximate 1-100 nm regime and proposes that risks be prioritized based on the emergence of novel, size-dependent biological or environmental activity within that range. It makes no sweeping statements about the dangers of any particular nanomaterial, class of nanomaterial, or type of nano-enabled product. It identifies no significant risks common to all nanomaterials, stating in fact that “the size range used to describe ENMs – 1-100 nm – has relatively little bearing itself in determining the risk to people or the environment.”
Nonetheless, the report has drawn attention from the media, with several articles adopting a negative tone mirroring the Academies’ own press release, which said “the future of safe and sustainable nanotechnology is uncertain.” Major coverage includes Cornelia Dean’s article in the New York Times and Robert Service’s piece for ScienceInsider, Science Magazine’s online policy blog. Meanwhile the National Nanotechnology Coordination Office has issued a press release emphasizing that the report credits the NNI with effectively moving nanomaterials-related EHS research forward while noting the many commonalities between the NRC strategy and the current NNI EHS research strategy. These include:
- Utilization of lifecycle analysis
- Stakeholder participation and engagement
- Regular reviews in order to adapt to evolving research needs
- Increased research on human exposure, human health effects, and environmental effects
- Development of better characterization tools, exposure monitoring tools, and informatics infrastructure
NNCO has also posted a document providing direct comparisons between the relevant sections of the two strategies. They have not commented as yet on what is sure to be one of the committee’s more controversial recommendations – that the coordination of nanoEHS research among the NNI agencies should not be part of the NNCO’s role but should vest in a separate entity with both budgetary and top-down programmatic authority. We are skeptical about this suggestion for both pragmatic and philosophical reasons:
1. Federal agencies are reluctant to cede budgetary authority and programmatic authority to other entities with distinct missions, and Congress does not like them to do so.
2. In the committee’s own words, “the development and use of new materials cannot be separated from questions of potential risk. Understanding and addressing the EHS implications of ENMs is intricately entwined with their development.”
Agencies whose primary mission is closely aligned with development – for example, the National Institute of Standards and Technology and the National Science Foundation – have been major contributors to NNI’s EHS research portfolio so far. It is difficult to see how their level of interest and investment could be maintained if the coordination of EHS activities was rigidly separated from the rest of the NNI agenda.
But overall there is much to like in this report. We join the committee in noting the substantial progress that has been made in nano-EHS in the last five years, and are in agreement with many of its proposals for continuing to develop our knowledge of nanomaterial interactions in order to accelerate the responsible development of nanotechnology. This is a long and complex document, and we expect the discussion of specific recommendations to evolve as various interest groups identify and analyze parts they find particularly relevant. NanoBCA should be part of that discussion, asking ourselves whether the prioritization methods the committee recommends point to particular questions relevant to our members product development efforts, how we would benefit from participating in coordinated research, and what we have to contribute (knowledge, materials, resources). It will be important to remind many of the other interested parties that while the committee speaks of a knowledge gap, this should not be interpreted as meaning that we are currently incapable of adequately assessing the risks and benefits of individual nano-enabled products. The reference point for this report is not the regulatory review of individual nanomaterials but rather a model for moving beyond case-by-case analysis to assess classes of nanomaterials in a systematic, comprehensive way. The predictive capabilities and rapid evaluation techniques the committee envisions would certainly accelerate the development of safe, high performance nanomaterials and sustainable processes for manufacturing, using, and ultimately disposing of them. This would put our community in an enviable position. The challenge, from the industry perspective, is to get to this new, higher state of knowledge without placing an undue (and unequal) burden on commercial enterprises and without impeding the parallel progress of nanomaterials through the regulatory pathways we have all worked so hard to clarify.
Members of the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials
JONATHAN M. SAMET (Chair), University of Southern California, Los Angeles
TINA BAHADORI, American Chemistry Council, Washington, DC
JURRON BRADLEY, BASF, Florham Park, NJ
SETH COE-SULLIVAN, QD Vision, Inc., Lexington, MA
VICKI L. COLVIN, Rice University, Houston, TX
EDWARD D. CRANDALL, University of Southern California, Los Angeles
RICHARD A. DENISON, Environmental Defense Fund, Washington, DC
WILLIAM H. FARLAND, Colorado State University, Fort Collins
MARTIN FRITTS, SAIC-Frederick, Frederick, MD
PHILIP HOPKE, Clarkson University, Potsdam, NY
JAMES E. HUTCHISON, University of Oregon, Eugene
REBECCA D. KLAPER, University of Wisconsin, Milwaukee
GREGORY V. LOWRY, Carnegie Mellon University, Pittsburgh, PA
ANDREW MAYNARD, University of Michigan School of Public Health, Ann Arbor
GUNTER OBERDORSTER, University of Rochester School of Medicine and Dentistry, Rochester, NY
KATHLEEN M. REST, Union of Concerned Scientists, Cambridge, MA
MARK J. UTELL, University of Rochester School of Medicine and Dentistry, Rochester, NY
DAVID B. WARHEIT, DuPont Haskell Global Centers for Health and Environmental Sciences,
MARK R. WIESNER, Duke University, Durham, NC
We have attempted to provide an unbiased view of the NRC report. Thank you for reading this lengthy analysis and please email any questions.
Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
NanoBusiness Commercialization Association