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Project Title: Guidance for and Review of EPA's IRIS Toxicological Assessment of Inorganic Arsenic

PIN: DELS-BEST-12-01         

Major Unit:
Division on Earth and Life Studies

Sub Unit:
Board on Environmental Studies & Toxicology

RSO:
Martel, Susan

Subject/Focus Area:
Environment and Environmental Studies; Policy for Science and Technology


Workshop on the Toxicologic Assessment of Inorganic Arsenic
April 4, 2013 - April 5, 2013
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:
Fax:


Agenda:

**This Event Will Be Webcast (Visit http://www.tvworldwide.com/events/nas/130404/). Webcast archives will be available after the event on the host site.**

WORKSHOP
Inorganic Arsenic: Scientific Considerations for Hazard Identification and Dose-Response Analysis

April 4, 2013

NATIONAL RESEARCH COUNCIL
2101 Constitution Avenue, NW
Lecture Room
Washington, DC

PLEASE NOTE: Due to limited space, advanced registration is required to attend this workshop. You must request to attend by sending an email to tdawson@nas.edu with the Subject Header "NRC Inorganic Arsenic April Workshop" and request to attend in person or by webcast. All requests must be received by 5PM EDT, March 28, 2013. Confirmations will be sent by 5PM EDT, March 29, 2013.

7:30 am
REGISTRATION

7:45 am
Welcome and Introduction
Joseph Graziano, Committee Chair

8:00 am
Update on EPA's Inorganic Arsenic Activities
Kenneth Olden and Vincent Cogliano, U.S. Environmental Protection Agency

Strengths and Weaknesses of Recent Epidemiologic Studies of Inorganic Arsenic
8:15 am
Cancer Evidence and Dose-Response Relationships
Kenneth Cantor, National Cancer Institute

8:45 am
Noncancer Evidence and Dose-Response Relationships
Craig Steinmaus, California Environmental Protection Agency, University of California at Berkeley


Integration of Metabolism and Mode of Action Information in Hazard Identification and Dose-Response Analyses
9:15 am
Metabolism, Its Consequences, and Implications for Low Dose Assessments
David Thomas, U.S. Environmental Protection Agency

9:40 am
Mode of Action and Mechanism Identification and Implications for Low Dose Assessments
Samuel Cohen, University of Nebraska Medical Center

10:05 am
Interplay Between One-carbon Metabolism, Arsenic Metabolism and Epigenetics
Mary Gamble, Columbia University

10:30 am
BREAK

10:45 am
Mode of Action for Lung and Cardiovascular Effects
R. Clark Lantz, University of Arizona

11:10 am
Impact of In Utero and Whole Life Exposure and Implications for Dose Response
Michael Waalkes, National Institute for Environmental Health Sciences

11:35 am
Panel Discussion:
Moderators: Aaron Barchowsky and Rebecca Fry
1. Are there data that support low dose mechanisms and modes of action?
2. Is there a continuum of common thread in cancer and noncancer mechanisms and modes of action?
3. Are there gender and species differences in metabolism or modes of action that impact dose response and disease susceptibility?
4. Do the kinetics and dynamics of inorganic arsenic and its metabolites in different organs promote organ-specific disease?

12:30 pm
BREAK

Probabilistic Dose-Response and Harmonization Approaches for Cancer and Noncancer Effects
1:30 pm
Lessons Learned from Lead and Particulate Matter
Joel Schwartz, Harvard School of Public Health

2:00 pm
Extrapolation of Mode of Action Data to Dose-Response Modeling of Human Health End Points
Harvey Clewell, The Hamner Institutes of Health Sciences

2:30 pm
Panel Discussion:
Moderators: Gary Ginsberg and Robert Wright
Discussant: Daniel Axelrad, U.S. Environmental Protection Agency
1. Do the available gene expression data define a coherent mechanism for cancer and noncancer effects?
2. Do these data adequately describe the array of effects at low dose?
3. How might the mode of action based dose response be affected by population variability?
4. How would one construct a probabilistic assessment of noncancer dose response from which the probability of an adverse effect can be estimated at any dose?
5. What are the implications of mode of action based and probabilitstic-based assessments for risk-benefit analysis?

3:00 pm
BREAK

Risk Assessment Approaches and Application of IRIS Values
3:15 pm
Systematic Review and Evidence Integration for Literature-Based Environmental Health Assessments
Andrew Rooney, U.S. National Toxicology Program

3:45 pm
Perspectives of Risk Assessors and Users of IRIS Values
Question: Given your experience in risk assessment activities, what aspects of the Toxicological Review of Inorganic Arsenic would be critical for maximizing the utility and credibility of the review for the risk assessments that you undertake?
Barbara Beck, Gradient Corporation
Michael Hansen, Consumers Union
Kate Sande, Minnesota Department of Health
Joyce Tsuji, Exponent, Inc.

4:10 pm
Panel Discussion:
Moderators: Sandra Baird and Hugh Barton
Question 1: Joyce Tsuji and Michael Hansen

1a. “Science and Decisions” (NRC 2009) recommended that EPA adopt a unified dose-response assessment framework for cancer and noncancer end points. It has been suggested that an arsenic IRIS assessment might provide:

a. Risk estimates for noncancer end points (rather than or in addition to a concentration assumed to be health protective, such as an RfD)
b. Nonlinear cancer assessment
c. Multiple risk estimates for a single toxicity end point (e.g., alternative mode of action hypotheses, estimates from different studies, multiple dose-response models fitted to the same data)
d. Risk estimates for many toxicity end points

What recommendations do you have for EPA on use of these approaches?

1b. If the toxicological review of inorganic arsenic contains risk estimates derived from the dose-response approaches described in Question 1a, how would that impact the practice of risk assessment in the activities you are involved in?

Question 2: Barbara Beck and Kate Sande

2a. EPA has been asked by stakeholders to explicitly include consideration of populations that may have increased susceptibility to the adverse effects from arsenic (e.g., life stages, genetics, pre-existing disease, and environmental stressors such as co-exposures and nutritional deficiencies). What type of quantitative estimates of susceptibility would be useful in your risk assessment activities? If quantitative estimates cannot be derived, how do you recommend EPA provide information on susceptibility so that it can be used to inform your risk assessment activities?

2b. What types of documentation (and level of detail) are necessary to assist you and other users of an IRIS assessment if one of these approaches (which are not currently standard methods) were used?

5:00 pm
Additional Questions for Workshop Speakers and Panelists from Committee

5:20 pm
OPEN MICROPHONE
Each speaker has a maximum time limit of 5 minutes. Accompanying written materials are encouraged.

6:00 pm
ADJOURN


Closed Session Summary Posted After the Meeting

The following committee members were present at the closed sessions of the meeting:
Joseph Graziano (Chair)
Habibul Ahsan
Aaron Barchowsky
Hugh Barton
Gary Carlson
Mary Davis
Yvonne Dragan
Rebecca Fry
Chris Gennings
Gary Ginsberg
Margaret Karagas
James MacDonald
Ana Navas-Acien
Marie Vahter
and Robert Wright (via conference call).

The following topics were discussed in the closed sessions:
1. Discuss workshop proceedings and submissions
2. Draft report outline

The following materials (written documents) were made available to the committee in the closed sessions:
IA-9. Michael Waalkes, National Institute for Environmental Health Sciences
March 27, 2013
PowerPoint Presentation
Waalkes, M.P. 2013. Impact of In Utero and Whole Life Exposure in Rodents and Implications for Dose Response.

IA-10. David Thomas, U.S. Environmental Protection Agency
March 29, 2013
PowerPoint Presentation
Thomas, D.J. 2013. Arsenic Metabolism, Its Consequences, and Implications for Low Dose Assessments.

IA-11. Craig Steinmaus, California Environmental Protection Agency, University of California at Berkeley
April 1, 2013
PowerPoint Presentation
Steinmaus, C. 2013. Non-cancer outcomes and ingested arsenic.

IA-12. Samuel Cohen, University of Nebraska Medical Center
April 1, 2013
PowerPoint Presentation
Cohen, S.M. 2013. Mode of Action and Mechanism: Identification and Implications for Low Dose Assessments.

IA-13. R. Clark Lantz, University of Arizona
April 1, 2013
PowerPoint Presentation
Lantz, R.C. 2013. Mode of Action for Lung and Cardiovascular Effects.

IA-14. Kate Sande, Minnesota Department of Health
April 1, 2013
PowerPoint Presentation

IA-15. Joyce Tsuji, Exponent, Inc.
April 1, 2013
PowerPoint Presentation
Brief Comments Regarding a United Dose-Response Assessment for Arsenic Cancer and Noncancer Toxicity.

IA-16. Mary Gamble, Columbia University
April 2, 2013
PowerPoint Presentation
Gamble, M.V. 2013. Interplay Between One-carbon Metabolism, Arsenic Metabolism and Epigenetics.

IA-17. Barbara Beck, Gradient Corporation
April 2, 2013
PowerPoint Presentation
Beck, B.D. 2013. Risk Assessment and Application of IRIS Values: Consideration of Susceptibility and Variability.

IA-18. Michael Hansen, Consumers Union
April 2, 2013
PowerPoint Presentation
Hansen, M. 2013. Aspects of the Toxicological Review of Inorganic Arsenic Critical for Maximizing its Utility and Creditability for Public Interest Risk Assessment.

IA-19. Kenneth Cantor, National Cancer Institute
April 3, 2013
PowerPoint Presentation
Cantor, K.P. 2013. Strengths and Weaknesses of Recent Epidemiologic Studies of Inorganic Arsenic: Cancer Evidence.

IA-20. Joel Schwartz, Harvard School of Public Health
April 3, 2013
PowerPoint Presentation
Schwartz, J. Risk Assessment and Epidemiology.

IA-21. Harvey Clewell, The Hamner Institutes of Health Sciences
April 3, 2013
PowerPoint Presentation
Clewell, III, H. 2013. Extrapolation of Mode of Action Data to Dose-Response Modeling of Human Health End Points.

IA-22. Andrew Rooney, U.S. National Toxicology Program
April 3, 2013
PowerPoint Presentation
Rooney, A. 2013. Systematic Review and Evidence Integration for Literature-Based Environmental Health Assessments.

IA-23. Vincent Cogliano, U.S. environmental Protection Agency
April 4, 2013
PowerPoint Presentation
Cogliano, V. 2013. Materials in Support of NRC’s Review of the IRIS Toxicological Review of Inorganic Arsenic.


Date of posting of Closed Session Summary: April 8, 2013