T1-A
Managing uncertain risks for nanotechnology developmentBaltimore A 9:40 AM
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| Chair(s): Jeff Steevens, Igor Linkov linkov@cambridgeenvironmental.com, jeffery.a.steevens@us.army.mil
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| Nanotechnology is a broad and complex area with many decisions that must be made, covering such issues as allocating funding for appropriate projects, predicting which nanomaterials will have favorable chemical characteristics and lower toxicity, identifying important knowledge and technology gaps, and communication with stakeholders and the public. However, there is currently no structured approach for making justifiable and transparent decisions with explicit trade-offs between the many factors that need to be taken into account. Rapid developments in the field of nanotechnology require immediate attention to be focused on assessing environmental and health risks associated with nanomaterials, an also on making regulatory decisions to reduce these risks. This session will present current efforts underway to address the potential risks of nanomaterials while supporting technology development. |
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T1-A.1 9:40 AM Nanotechnology: Integrating risk assessment and decision analysis . Linkov I*, Satterstrom FK, Steevens J, Ferguson E, Kim J, Suedel B; Cambridge Environmental Inc., US Army Engineer Research and Development center linkov@cambridgeenvironmental.com
Abstract: Even though nanotechnology application is widespread, understanding of the environmental effects and risks associated with nanomaterial use is very limited and often contradictory. Regulatory experience with inorganic and organic chemicals may not be directly relevant to nanomaterials since their physical and biological properties are often determined not only by their size or structure, but rather by functionalization that was engineered to achieve specific manufacturing goals. An additional challenge is balancing environmental and societal goods and risks associated with nanomaterials. This presentation combines state-of-the-art research in Multi Criteria Decision Analysis (MCDA) methods applicable to nanotechnology with a hypothetical case study for nanomaterials management. This example shows how MCDA application can balance societal benefits versus unintended side effects and risks, and how it can also bring together multiple lines of evidence to decide on the likely toxicity of nanomaterial given limited information on physical and chemical properties. The essential contribution of MCDA is to link this performance information with decision criteria and weightings elicited from scientists and managers, allowing visualization and quantification of the trade-offs involved in the decision-making process.
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T1-A.2 9:50 AM Nanotechnology decision support needs. Morris J*, Willis J, Gallagher K, Alwood A, Bauer D, Boethling R, Brody M, Burgin D, Chow F, Dreher K, Fairbrother A, Henry T, Karn B, Libelo L, Lingle S, Nabholz J, Prothero S, Savage N, Sayre P, Scalera J, Schoepf W, Street A, Utterback D, Williamson T, Zepp R; United States Environmnetal Protection Agency gallagher.kathryn@epa.gov
Abstract: Nanotechnology offers the potential to create new and better products and to improve how we measure, monitor, manage, and minimize contaminants in the environment. Nanotechnology also presents challenges regarding understanding the potential impacts of nanomaterials on human health and the environment, and making decisions based on limited data. For the past five years, the US EPA has played a leading role in funding research and setting research directions to develop environmental applications for, and understand the potential human health and environmental implications of, nanotechnology. Additionally, a number of specific nanomaterials have come to the Agency's attention, whether as novel products intended to promote the reduction or remediation of pollution or because they have entered one of US EPA's regulatory review processes. In December 2004, US EPA's Science Policy Council formed an intra-Agency Nanotechnology Workgroup to develop a white paper examining potential environmental implications and applications of nanotechnology. The paper provides an extensive description of environmental decision support needs and provides recommendations to begin addressing those needs. Agency managers and staff have been working together to develop an approach to nanotechnology that is forward thinking and informs the risk assessment and risk management activities and decision-making in our program and regional offices. This presentation addresses US EPA's Nanotechnology White Paper and identified environmental decision support needs.
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T1-A.3 10:00 AM The emerging nano regulatory decision-making process: Views from within and outside EPA. Bergeson LL*; Bergeson & Campbell, P.C. lbergeson@lawbc.com
Abstract: Federal regulatory agencies are moving quickly to demonstrate that they are up to meeting whatever health and safety challenges are posed by engineered nanoscale materials. The need to do so is more acute now as the commercialization of products containing some element of nanotechnology or engineered nanoscale component, particularly consumer products, is more widely known, but not in all cases well understood. Federal agencies with product approval authority, particularly US EPA, are developing procedures and appropriate risk paradigms to demonstrate that public health and environmental protection are assured while the benefits of nanotechnologies continue to be realized. This presentation will review these emerging decision-making processes as applied to new or modified industrial and agricultural chemicals under the federal laws intended to manage risks posed by industrial chemicals (TSCA) and pesticides (FIFRA), respectively. Also reviewed will be emerging innovative environment, health, and safety management and accountability mechanisms business and other stakeholders are developing that are augmenting the role the government traditionally has played in assuring public health and environmental protection.
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T1-A.4 10:10 AM FDA and nanotechnology. Canady RA*; US FDA richard.canady@fda.hhs.gov
Abstract: FDA regulatory authority extends to a wide range of products within which nanotechnology might be employed. Regulatory requirements vary across categories of products such as food additives, food packaging, dietary supplements, drugs, cosmetics, and medical devices. FDA generally regulates the products, not the technologies upon which they rely while employing knowledge of the underlying or producing technologies as necessary, to aid in understanding of safety or effectiveness. The emerging nature and uses of nanotechnology and growing hazard identification literature on specific nanoparticles might lead to a sense of uncertainty about risk evaluation approaches or regulatory requirements for products employing any kind of nanotechnology. An undesirable result of that generalized uncertainty may be lost opportunities for health and well-being gains through new products that may have no relationship to the nanoparticles for which hazards have been identified. It is therefore worthwhile to establish lines of communication that can identify challenges early and adapt data requirements and review expectations to both ensure safety and not unduly impede progress. Product developers can, for example, take advantage of early consultation mechanisms that many FDA review programs have developed. Such mechanisms can help developers to benefit in early design and testing decisions from improving understanding of the characteristics of nanotechnology materials relevant to FDA regulation of products made with them.*
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T1-A.5 10:20 AM Managing nanotechnology EHS risks amidst uncertainty: A practical approach. Hull MS*; Luna Innovations Incorporated hullm@lunainnovations.com
Abstract: Despite a growing list of beneficial applications of nanotechnology in areas (e.g., medical imaging, disease therapeutics, energy storage, water purification, and many others) uncertainty surrounding the potentially harmful attributes of engineered nanomaterials pose challenges to widespread acceptance of this emerging industry. Clearly, more information is needed to determine accurately the environmental health and safety (EHS) issues surrounding commercial and federal pursuit of nanotechnology. Of particular interest are applications of nanotechnology that pose the greatest opportunities for human and environmental exposures and exposure-related health impacts. Despite the urgent need for more information and guidance on nanotechnology EHS issues, efforts must be taken now to manage the nano risks we know, while incorporating a sufficient level of protection against those we have yet to fully characterize. This presentation highlights the key elements of a practical and adaptive approach taken by industry to manage nanotechnology EHS risks proactively and amidst uncertainty. The approach emphasizes a number of tools and strategies for minimizing risks including: routine monitoring, cost-efficient process modifications, employee safety training and awareness, open communication with federal research labs and regulators, collaboration with academia, and adaptability amidst emerging findings on nanotechnology EHS.
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T1-A.6 10:30 AM Getting nanotechnology right the first time. Denison RA*; Environmental Defense rdenison@environmentaldefense.org
Abstract: Environmental Defense has identified three key needs to advance responsible development of nanotechnology: A sharp increase in the pace and scope of both federal and private-sector research into potential risks; improvements in regulatory policy to ensure that identified risks are effectively and comprehensively addressed; and proactive development and wide adoption by industry of "standards of care." In this presentation we will provide our perspective on these key needs and on the specific efforts now underway and still needed to meet them.
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T1-A.7 10:40 AM Discussion
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