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Project Title: A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials

PIN: BEST-K-08-01-A         

Major Unit:
Division on Earth and Life Studies

Sub Unit:
Board on Environmental Studies & Toxicology
Board on Chemical Sciences and Technology
DEPS National Materials Advisory Board

RSO:
Martel, Susan

Subject/Focus Area:



Environmental, Health, and Safety Aspects of Engineered Nanomaterials Mtg. 7
November 7, 2012 - November 9, 2012
National Academy of Sciences Building
2100 C St. NW
Washington D.C.


If you would like to attend the sessions of this meeting that are open
to the public or need more information please contact:


Contact Name: Tamara Dawson
Email: tdawson@nas.edu
Phone: 202-334-2776
Fax:


Agenda:

PLEASE NOTE: Due to limited space, advanced registration is required to attend this workshop. Send an email to tdawson@nas.edu with the Subject Header "NRC EHS Nanomaterials Workshop" and request to attend in person or by phone conference.

Research Progress on Environmental, Health, and Safety Aspects of Nanotechnology

November 7, 2012 – 8:00-5:45 – National Academies, 2101 Constitution Avenue, NW, Lecture Room

As the nanotechnology sector has expanded, questions regarding the possible environmental and human health risks posed by engineered nanomaterials (ENMs) have been raised, fueled in part by their increased production, realization that adequate methods are not available to detect and characterize many materials, and recognition that many materials are in products or environments where exposures potentially occur. In response to these concerns, there has been an increase in efforts by government agencies, in particular the National Nanotechnology Initiative (NNI); academic institutions; and industry to research, translate, and communicate information on the environmental and health aspects of nanotechnology. As a part of this effort, the National Research Council released a report in January 2012, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. This workshop will examine what research progress has ensued since release of the NRC report, and what other efforts are underway to address the scientific uncertainties and research infrastructure needs for a robust research approach to environmental, health, and safety issues related to ENMs. Information gathered from this workshop will inform a second NRC report that will examine research progress.

8:00 Opening remarks and introductions
Jonathan Samet*, University of Southern California

8:15-9:45 Emerging materials and emerging issues (Moderators: William Farland*, Colorado State University; Seth Coe-Sullivan*, QD Vision, Inc.)
<15 min/speaker, 30 min discussion>

Current and future nanotechnology marketplace
Michael Holman, Lux Research (via conference call)
President’s Council of Advisors on Science and Technology – review of NNI and future directions in EHS research
Maxine Savitz, Honeywell Corporation (retired)
EPA New Chemicals Program – nanomaterials
James Alwood, U.S. Environmental Protection Agency
International perspective
Georgios Katalagarianakis, European Commission (via videoconference)

This session will address public and private sector perspectives regarding ENMs and new issues that will arise as research and data are generated on materials in commerce and those under development, helping to inform future research directions. Both national and international perspectives will be sought. Because the number of products containing nanomaterials is expected to explode, and future exposure scenarios may not resemble those of today, selecting appropriate materials to study is challenging.

Specific questions to consider:

- What is the perspective on the size, character, and direction of the marketplace for nanomaterial-containing products?
- What sources of information can be used by the NNI and others to identify recently developed, novel materials that merit emphasis from exposure, health, and safety research perspectives?
- Are significant new uses for existing materials likely to lead to novel exposure pathways or potential health and safety issues?
- Based on recent experience, are regulatory pre-manufacture/pre-market review processes adequate to flag these emerging materials/issues to permit research to inform their safe use?
- What role will the proprietary nature of much of the information play in limiting the ability to carry out strategic and timely research?
- How can information on emerging materials/issues from public and private sources be effectively conveyed and leveraged to address research needs?


9:45 Break
10:00-12:00 Institutional needs to support the research enterprise (Moderators: William Farland*, Colorado State University, Andrew Maynard*, University of Michigan)
<10 min/speaker, 50 min discussion>

Sally Tinkle, National Nanotechnology Coordination Office
Tina Bahadori, U.S. Environmental Protection Agency
Christopher Weis, National Institute of Environmental Health Sciences
Charles Geraci, National Institute for Occupational Safety and Health
Mike Roco, National Science Foundation
Teresa Croce, U.S. Food and Drug Administration
Scott McNeil, National Cancer Institute

This session will seek input from representatives of key federal agencies concerning recent efforts made at addressing institutional needs to support the research enterprise and what additional efforts would contribute value. Consideration should be given to metrics that can serve as a benchmarks to encourage development of these institutional needs.
Specific questions to consider:
- What additional efforts could help ensure coordination of research between the federal government, academia, the private sector, and internationally?
- What is the best means of ensuring that EHS priority research areas that are identified (either in agency strategies or in other assessments) receive the needed funding to pursue research objectives and that the research objectives are addressed?
- How have recent efforts at increasing stakeholder involvement enhanced research planning? What additional emphases are needed to encourage and foster stakeholder involvement?
- What has been the added value of newly established public-private partnerships? What is needed to encourage additional partnerships?
- What efforts are being done or should be taken to ensure that sufficient attention is given to understanding the potential human and environmental implications of nanotechnology?
12:00 Lunch

1:00 Discussion with researchers (Moderator: Mark Wiesner*, Duke University)
<10 min/speaker, 30 min discussion>

Human health
Martin Philbert, University of Michigan
Toxicology
Robert Tanguay, Oregon State University
Fate, transport, ecosystem
Mark Wiesner*, Duke University

Speakers will discuss research directions and initiatives that they consider to be of the highest priority for addressing uncertainties regarding EHS aspects of ENMs. Consideration should be given to how the research will decrease uncertainty regarding potential ENM risks, and how research outcomes could be used to help address decision-making regarding ENM applications and regulations.
Questions to consider:
- Have you implemented or do you plan to implement informatics/cyber infrastructure tools for synthesizing data sets to generate different questions than those posed using traditional research tools?
- Is there a focus on identifying and studying particular ENMs that are most likely to present a concern regarding exposures?
- Are there initiatives to reallocate resources to focus on fundamental cross-cutting research questions that can inform both exposures and effects?
- How is the information gathered on exposure and effects studies used to inform risk analysis and to support decision making with regard to ENM use and to possible regulations?
- Is research aimed in part at determining ENM behaviors in complex systems (for example, whole organism or ecosystem level)? What approaches are being used?

2:00 Tool development (Moderators: Greg Lowry*, Carnegie Mellon University and Jim Hutchison*, University of Oregon)
<10 min/speaker, 30 min discussion>

Characterization of materials/standard reference materials
Vince Hackley, National Institute of Standards and Technology
Environmental exposure modeling, integration of experimental data and its use in informing models
Jamie Lead, University of South Carolina
Informatics and modeling
Nathan Baker, Pacific Northwest National Laboratory (via conference call)

This session will address progress and innovations in the development of tools needed to address critical research priorities for understanding the EHS aspects of ENMs. Specific tools of interest include informatics, exposure and effects models, methods to measure ENMs in complex media, and standard test and reference materials.
Questions to consider:
- Is there a path towards developing tools needed to characterize ENMs in environmental and
biological matrices at relevant concentrations? Has this been a coordinated effort?
- What progress is being made in developing exposure models and effect models for ENMs? Are initiatives in place to validate such models (for example, exposure models, dosimetry models)?
- Are standard test and reference materials becoming available to the EHS nanomaterial community? What mechanisms are in place to facilitate this?
- Are informatics tools available for nanoEHS research? What mechanisms have been implemented to facilitate the development/use of these tools? Are there efforts to collect and archive metadata in a manner that allows data mining and metadata analysis? Are metadata standards available or are they being developed?
- What progress has been made toward integrating the tools used by the various communities evaluating nanoEHS and nano-enabled devices (for example, nanomedicine; TOXCAST, NCI, exposure modeling; coupling a fate and transport model with an ecotoxicity model)?
- Have standard tests been developed/implemented for toxicity testing of ENMs? What progress has been made toward this goal?

3:00 Discussion with technical program managers (Moderators: Mark Wiesner*, Duke University; Rebecca Klaper*, University of Wisconsin)
<10 min/speaker; 50 min discussion>

Tina Bahadori, U.S. Environmental Protection Agency
Barbara Karn, National Science Foundation
Paul Schulte, National Institute for Occupational Safety and Health
Srikanth (Sri) Nadadur, National Institute of Environmental Health Sciences/National Toxicology Program

Speakers will discuss current and planned research efforts to address priority research needs, including how agency research projects and extramural funding efforts are being shaped by the emerging data.
Questions
- How have recent research progress and findings influenced your research program directions?
- What resources have been made available to enable implementation of informatics/cyber infrastructure tools?
- What efforts have been made and what resources have been allocated to enable data sharing and/or archiving of metadata to ensure that it will be accessible to the broader nanoEHS community and capable of being mined?
- Are there specific populations and exposure routes that are targeted as priorities for research?
- Are there cross-agency/mission requests for cross-cutting research (for example, EPA/NIH) that will inform decisions with respect to both nanomaterial exposure and effects?
- Are there specific models for data integration and generalization of EHS nanomaterial risks that your agency desires to populate through specific calls for research? If so, what are they?
- Is there research aimed at determining ENM behaviors in complex systems (for example, full organism or ecosystem level)? If so, how are you approaching this move away from traditional deductive to inductive research approaches?
- What approaches do you envision for addressing future generations of more complex and active nanomaterials that may not conform to simple dose-response approaches for single component materials?
- Have modifications been made to RfPs or research strategies in light of research priorities articulated by the NNCO, NRC, or other organizations?
4:30 Break
4:45-5:45 Cross-cutting discussion - stakeholders’ perspectives (Moderators: Andrew Maynard*, University of Michigan; Richard Denison*, Environmental Defense)
<5 min/speaker, 40 min discussion>

Carolyn Cairns, Consumers Union
Anna Fendley, United Steel Workers
Skip Rung, Oregon Nanoscience and Microtechnologies Institute (ONAMI)
Seth Coe-Sullivan*, QD Vision, Inc.

The safe and responsible development and use of nanotechnology and its related products affect and are shaped by diverse stakeholders. As such, there is a need to ensure that research strategies are responsive to the interests and concerns of these groups. This session aims to present the perspectives from representatives of academia, industry, labor, and environmental groups on: (1) the extent of progress made to advance research to address the potential health and environmental impacts of nanotechnology; and (2) how effective current mechanisms have been to facilitate and sustain stakeholder engagement in developing and implementing the needed research.
Participants in this panel will provide:
- Reactions to the discussions from the workshop considering the charge of this NRC committee and the needs for the second report.
- Input on stakeholder engagement, specifically responding to two questions:
1. What progress has been made to establish more effective mechanisms of engagement between government agencies and stakeholders?
2. What further action could be taken to enhance existing or establish new mechanisms of engagement?


*member of the NRC Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials


Closed Session Summary Posted After the Meeting

The following committee members were present at the closed sessions of the meeting:
Jonathan Samet (Chair)
Seth Coe-Sullivan
Vicki Colvin
Edward Crandall
Richard Denison
William Farland
Martin Fritts
Philip Hopke
James Hutchison
Rebecca Klaper
Gregory Lowry
Andrew Maynard
Gunter Oberdörster
Kathleen Rest
David Warheit
Mark Wiesner
Mark Utell (via teleconference)

The following topics were discussed in the closed sessions:
1) Additional information needs
2) Development of report outline
3) Assignments and plans for development of the report


The following materials (written documents) were made available to the committee in the closed sessions:
1. Murashov, V. , P. Schulte, J. Howard. 2012. Commentary: Progression of occupational risk management with advances in nanomaterials. J. of Occupational and Environmental Hygiene. 9:D12-D22.

Date of posting of Closed Session Summary: November 13, 2012