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Meeting Information



Project Title: Review of the IRIS Process

PIN: DELS-BEST-11-04         

Major Unit:
Division on Earth and Life Studies

Sub Unit:
Board on Environmental Studies & Toxicology

RSO:
Mantus, Ellen

Subject/Focus Area:
Environment and Environmental Studies


2nd Review of the IRIS Process Meeting
December 13, 2012 - December 14, 2012
Arnold and Mabel Beckman Center
100 Academy Dr.
Irvine, California


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: Craig Philip
Email: cphilip@nas.edu
Phone: 202-334-1942
Fax: 202-334-2752


Agenda:

NOTE: For those unable to travel to Irvine, CA, for the upcoming meeting of the Committee to Review the IRIS Process, we will provide a video conference room at the National Academies Keck Center (Room 201) in Washington, DC that will link to the open session and allow guests to interact at the appropriate times. Please RSVP to Craig Philip at cphilip@nas.edu, if you would like to participate via the Keck Center.

Board on Environmental Studies and Toxicology


NATIONAL RESEARCH COUNCIL
SECOND MEETING OF THE COMMITTEE TO REVIEW THE IRIS PROCESS

Open Session: December 13, 2012
National Academies Beckman Center
Huntington Room
100 Academy Way
Irvine, CA 92617
PH: 949-721-2200 / FAX: 949-721-2288



AGENDA (Times below are PST)


10:00 Purpose of Open Session and Introduction of Committee Members
Jonathan Samet
Chair, Committee to Review the IRIS Process
Professor and Flora L. Thornton Chair, Department of Preventive Medicine
Keck School of Medicine, University of Southern California

10:15 Overview of Current Process for Development of IRIS Drafts
Vincent Cogliano
Acting Director, IRIS Program
U.S. Environmental Protection Agency

Current (and Anticipated Future) Process for Development of IRIS Drafts

10:45 Step 1 – Identify Evidence
Glinda Cooper
IRIS Program
U.S. Environmental Protection Agency

11:25 Step 2 – Evaluate Evidence
Samantha Jones
IRIS Program
U.S. Environmental Protection Agency

12:05 BREAK FOR LUNCH

1:00 Step 3 – Evidence Integration
Lynn Flowers
Associate Director, National Center for Environmental Assessment
U.S. Environmental Protection Agency

1:40 Steps 4 and 5 – Select Studies and Calculate Reference Values
Weihsueh Chiu
IRIS Program
U.S. Environmental Protection Agency

2:20 Committee Discussion with EPA on Methods for IRIS Draft Development

EPA Staff and Committee to Review the IRIS Process

3:00 BREAK

3:30 Approaches for Conducting Health Assessments at the National Toxicology Program

Kristina Thayer
Director, Office of Health Assessment and Translation
National Toxicology Program

4:30 Workshop on Weight of Evidence – Discussion Session

EPA Staff and Committee to Review the IRIS Process

5:30 Open Microphone – Comments from the Audience

6:00 END PUBLIC SESSION


Closed Session Summary Posted After the Meeting

The following committee members were present at the closed sessions of the meeting:
Jonathan Samet (chair)
Scott Bartell
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
Joe Garcia
Miguel Hernán
James House (via teleconference)
Margaret MacDonell
Richard Scheines
Leonard Siegel
Robert Wallace
and Yiliang Zhu.

The following topics were discussed in the closed sessions:
1) Information presented in the open session and submitted to the committee.
2) Committee’s approach to its task and possible report structure.
3) Draft agenda for the weight-of-evidence workshop and possible speakers.
4) Schedule and agendas for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:
11. Letter and two articles—Linear low-dose extrapolation for noncancer health effects is the exception, not the rule and Practical risk assessment and management issues arising were we to adopt low-dose linearity for all endpoints—from Lorenz R. Rhomberg to Ellen Mantus. Received on November 5, 2012.

12. Letter and two workshop discussion drafts from the American Chemistry Council to Ellen Mantus dated November 6, 2012.

13. Revised workshop discussion draft from the American Chemistry Council sent to Ellen Mantus on November 15, 2012.

14. Letter submitted by Kimberly Wise on behalf of the American Chemistry Council’s Chlorine Chemistry Division to Ellen Mantus dated November 26, 2012.

15. Letter submitted by Michael Dourson on behalf of the Alliance for Risk Assessment Dose Response Advisory Committee to Ellen Mantus dated November 30, 2012.

16. Preamble to IRIS Toxicological Reviews. Received from Norman Birchfield, EPA, on December 7, 2012.

17. Research Integrity Roundtable. Press Release and Report – Improving the Use of Science in Regulatory Decision-Making: Dealing with Conflict of Interest and Bias in Scientific Advisory Panels, and Improving Systematic Scientific Reviews. Received from Colleen Briley Daywalt, The Keystone Center, on October 1, 2012.

18. Overview of the Current Process for Development of IRIS Assessments. A PowerPoint presentation to the Committee to Review the IRIS Process by Vincent Cogliano, EPA, on December 13, 2012, in Irvine, CA.

19. Improvements to the Developments of the IRIS Health Assessments – Step 1. Literature Search Strategy and Identification of Evidence. A PowerPoint presentation to the Committee to Review the IRIS Process by Vincent Cogliano (for Glinda Copper), EPA, on December 13, 2012, in Irvine, CA.

20. Improvements to the Developments of the IRIS Health Assessments – Step 2. Evaluation of Evidence. A PowerPoint presentation to the Committee to Review the IRIS Process by Samantha Jones, EPA, on December 13, 2012, in Irvine, CA.

21. Improvements to the Developments of the IRIS Health Assessments – Step 3. Synthesis and Integration of Evidence. A PowerPoint presentation to the Committee to Review the IRIS Process by Lynn Flowers, EPA, on December 13, 2012, in Irvine, CA.

22. Improvements to the Developments of the IRIS Health Assessments – Steps 4 and 5. Selection of Studies and Derivation of Toxicity Values. A PowerPoint presentation to the Committee to Review the IRIS Process by Weihsueh A. Chiu, EPA, on December 13, 2012, in Irvine, CA.

23. Systematic Review and Evidence Integration for Literature-Based Assessments. A PowerPoint presentation to the Committee to Review the IRIS Process by Kristina Thayer, NTP, on December 13, 2012, in Irvine, CA.

24. Retooling of IRIS: What Progress Has Actually Been Made Over the Last 20 Months? Unfinished Business: Recommendations for the Path Forward to Success. A PowerPoint presentation at the Society for Risk Analysis Annual Meeting by Rick Becker, ACC, on December 12, 2012. Received on December 13, 2012.


Date of posting of Closed Session Summary: December 27, 2012