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Inorganic Arsenic Public Stakeholder Meeting- Agenda
UPDATE: The presentations and meeting materials are now available on the agenda.
EPA is announcing a public stakeholder workshop on the Integrated Risk Information System (IRIS) Toxicological Review of Inorganic Arsenic. This workshop is designed to inform the planning for EPA’s toxicological review of chronic exposure to inorganic arsenic (iAs) (cancer and non–cancer effects), which EPA intends to post to the Integrated Risk Information System (IRIS) database.
IRIS Inorganic Arsenic Public Stakeholder Workshop
January 8–9, 2013
8:00am–5:00pm
U.S. EPA
Auditorium C111
109 T.W. Alexander Drive
Research Triangle Park, NC 27711
Agenda (as of Jan 8, 2013) in Brief
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| 8:00 am 8:30 am 9:30 am 12:00–1:00 pm 1:00 pm 5:30 pm |
Registration Workshop begins Session 1 Lunch Session 2 Workshop adjourns |
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8:30 am 9:30 am 12:15–1:00 pm 1:00 pm 3:15 pm 5:00 pm |
Workshop begins Session 3 Lunch Session 4 Session 5 Workshop adjourns |
Day 1: Tuesday, January 8 , 2013
8:00am |
Registration |
8:30am |
Welcome and Overview
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8:45am |
Introductory Remarks – Partnerships and Approaches for the Future of IRIS Assessments
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9:15 am |
EPA Draft Planning and Scoping Summary for the Toxicological Review
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| Presentation | iAs Workshop Introduction Slides (PDF, 22 pp, 709Kb) |
SESSION 1: APPLYING SYSTEMATIC REVIEW TO THE iAs ASSESSMENT |
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Co–Chairs: |
Andy Rooney, National Institutes for Environmental and Health Sciences Roberta Scherer, Johns Hopkins University |
Panelists: |
Janice Lee, U.S. EPA National Center for Environmental Assessment Warner North, North Works Inc. Beth Owens, U.S. EPA National Center for Environmental Assessment Craig Steinmaus, CalEPA, University of California–Berkeley, University of California–San Francisco |
| Presentation | iAs Workshop Session 1 Slides (PDF, 30 pp, 1.7MB) |
9:30 am |
Elements of Systematic Review
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9:45 am |
Options for Literature Search Strategies
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10:00 am |
Break |
10:15 am
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Methods for Identifying, Evaluating, and Synthesizing Literature |
1.1 What approaches could EPA use to identify relevant literature for the development of a Toxicological Review of iAs? What approaches could EPA use to transparently communicate results of its literature search and screening strategy? Lead Discussants: Beth Owens, Andy Rooney |
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1.2. What approaches are available to evaluate the quality of individual studies? What aspects of epidemiological studies could be considered in such an evaluation? Lead Discussants: Andy Rooney, Craig Steinmaus |
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1.3. What approaches are available to synthesize the available evidence on iAs? Lead Discussants: Warner North, Roberta Scherer |
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| 11:15 am | Discussion (open to all on–site and virtual participants) |
| 12:00 pm | Lunch |
SESSION 2: APPROACHES FOR HAZARD IDENTIFICATION FOR iAs — NON–CANCER AND CANCER |
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Co–Chairs: |
Ken Cantor, National Cancer Institute David Thomas, U.S. EPA National Health and Environmental Effects Research Laboratory |
Panelists: |
Vasken Aposhian, University of Arizona Rory Conolly, U.S. EPA National Health and Environmental Effects Research Laboratory Craig Steinmaus, CalEPA, University of California–Berkeley, University of California – San Francisco Mirek Styblo, University of North Carolina Mike Waalkes, National Institute of Environmental and Health Sciences Tim Wade, U.S. EPA National Health and Environmental Effects Research Laboratory Doug Wolf, U.S. EPA National Health and Environmental Effects Research Laboratory |
| Presentation | iAs Workshop Session 2 Slides (PDF, 44 pp, 4.7MB) |
1:00 pm
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Noncancer and Cancer Effects – Identifying health effects and susceptible populations for hazard identification |
2.1. What data are available to identify noncancer effects following iAs exposure (oral or inhalation)? Lead Discussants: Mirek Styblo, Tim Wade |
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2.2. What data are available to identify cancer effects of iAs exposure (oral or inhalation)? Lead Discussants: Ken Cantor, David Thomas |
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2.3. What data are available to identify differences in susceptibility to the effects of iAs? Lead Discussant: Craig Steinmaus, Mike Waalkes |
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2:30 pm |
Discussion (open to all on–site and virtual participants) |
3:15 pm |
Break |
3:30 pm |
Mode–of–Action Evidence – Noncancer and cancer effects |
2.4. What data are available to identify mode(s) of action for the health effects of iAs (e.g., key toxicokinetic/toxicodynamic events; inter–species or inter–individual differences)? Lead Discussants: Vasken Aposhian, Doug Wolf |
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2.5. What data are available to identify common toxic moieties and mode(s) of action for multiple health effects (noncancer and cancer) from iAs exposure? Lead Discussants: Rory Connolly, Mirek Styblo |
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| 4:30 pm | Discussion (open to all on–site and virtual participants) |
| 5:30 pm | Day 1 Adjourns |
Day 2: Wednesday, January 9 , 2013 – THIS IS STILL IN DRAFT
8:30am |
Welcome and Overview
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SESSION 3: DOSE RESPONSE |
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| Co–Chairs: | Weihsueh Chiu, U.S. EPA National Center for Environmental Assessment William Cullen, University of British Columbia |
| Panelists: | Karen Bradham, U.S. EPA National Exposure Research Laboratory Ken Cantor, National Cancer Institute Hisham El–Masri, U.S. EPA National Health and Environmental Effects Lab Jeff Gift, U.S. EPA National Center for Environmental Assessment Bill Mendez, ICF International Warner North, North Works Inc. |
| Presentation | iAs Workshop Session 3 Slides (PDF, 54pp, 2.9MB) |
| 8:35 am | Identifying Factors Relevant to Dose Response |
3.1. What types of exposure could contribute to the aggregate dose, and in what ways might this impact how an iAs dose–response characterization is used/applied? How can we estimate impact of drinking water exposure alone vs. aggregate exposure on possible effects of iAs exposure? Lead Discussants: Karen Bradham, Bill Mendez |
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3.2. What kinds of endpoints may be useful for characterizing risk (e.g., precursor key events, clinical disease endpoints)? How are these endpoints linked to estimates of iAs dose or biomarkers (e.g. metabolites) in exposed populations? Lead Discussants: Ken Cantor, William Cullen | |
3.3. What kinds of dose–response characterization may be needed (e.g., reference value, incremental change in risk with dose, probabilistic risk at dose) for aggregate (e.g., urine, blood) and source–specific (e.g., food, water) dose metrics? Lead Discussants: Ken Cantor, Weihsueh Chiu |
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| 9:20 am | Approaches to Dose–Response Analysis |
3.4. What kinds of approaches are available to analyze dose–response data (e.g., statistical models, non–parametric approaches)? Lead Discussants: Weihsueh Chiu, Jeff Gift |
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3.5. What are factors (e.g., toxicokinetics, bioavailability, water consumption rates, background exposure, susceptibility) that can impact the dose response analysis, and how could these factors be transparently accounted for? Lead Discussants: William Cullen, Hisham El–Masri |
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3.6. EPA has traditionally addressed uncertainty in modeling dose-response data by using a statistical lower confidence bound on the benchmark dose. What other approaches are available to address and transparently convey the impact of uncertainty on the dose-response analysis? Lead Discussants: Bill Mendez, Warner North |
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10:20 am |
Break |
| 10:35 am | Extrapolation Approaches |
3.7. What kinds of extrapolations are needed (e.g., interspecies, exposure route, human variability, low–dose/effect)? Lead Discussants: Bill Mendez, Warner North |
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3.8. What approaches are available for such extrapolations (e.g., PBPK modeling, uncertainty factors, probabilistic factors, linear/non–linear dose–response)? Lead Discussants: Hisham El–Masri, Jeff Gift |
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3.9. EPA has traditionally addressed uncertainty via the application of uncertainty factors. What other approaches may be available to address and transparently convey the impact of uncertainty on these extrapolations? Lead Discussants: Ken Cantor, Weihsueh Chiu |
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11:20 am |
Discussion (open to all on–site and virtual participants) |
12:15 pm |
Lunch |
SESSION 4: ROUNDTABLE DISCUSSION ON PLANNING AND SCOPING |
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| Moderator: | Reeder Sams, U.S. EPA National Center for Environmental Assessment |
| Discussants: | Sam Cohen, University of Nebraska Vincent Cogliano, U.S. EPA National Center for Environmental Assessment Suzanne Fitzpatrick, U.S. Food and Drug Administration Deborah McKean, U.S. EPA Region 8 Michele Roberts, Advocates for Environmental Human Rights Mike Waalkes, National Institute of Environmental Health Sciences |
| Presentation | iAs Workshop Session 4 Slides (PDF, 28 pp, 2MB) |
| 1:00 pm | Discussion of Key Themes from Sessions 1-3
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2:30 pm |
Recommendations for Revisions to the Planning and Scoping Summary
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3:30 pm |
Break |
SESSION 5: OPPORTUNITY FOR ADDITIONAL PUBLIC COMMENT |
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| Moderator: | Janice Lee, U.S. EPA National Center for Environmental Assessment |
| 3:45 pm | Discussion (open to all on–site and virtual participants) |
| 4:45 pm | Concluding Remarks and Next Steps
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5:00 pm |
Workshop Adjourns |