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Project Information

Project Information


Review of the IRIS Process


Project Scope:

A committee of the National Research Council (NRC) will assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).  Specifically, the committee will review the IRIS process and the changes being implemented or planned by EPA and will recommend modifications or additional changes as appropriate to improve the scientific and technical performance of the IRIS program.  The committee will focus on the development of the IRIS assessments rather than the review process that follows draft development.  Because several reviews of IRIS assessments have expressed concerns about EPA’s weight-of-evidence analyses, the committee will review current methods for evidence-based reviews and recommend approaches for weighing scientific evidence for chemical hazard and dose-response assessments.

Status: Completed

PIN: DELS-BEST-11-04

Project Duration (months): 24 month(s)

RSO: Mantus, Ellen

Topic(s):

Environment and Environmental Studies



Geographic Focus:

Committee Membership

Committee Post Date: 06/18/2012

Jonathan M. Samet - (Chair)
University of Southern California

Jonathan M. Samet (chair) is a pulmonary physician and epidemiologist. He is a professor and Flora L. Thornton Chair of the Department of Preventive Medicine of the Keck School of Medicine of the University of Southern California (USC) and director of the USC Institute for Global Health. Dr. Samet’s research has focused on the health risks posed by inhaled pollutants. He has served on numerous committees concerned with public health: the U.S. Environmental Protection Agency Science Advisory Board; committees of the National Research Council (NRC), including chairing the Biological Effects of Ionizing Radiation VI Committee, the Committee on Research Priorities for Airborne Particulate Matter, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, and the Board on Environmental Studies and Toxicology; the National Cancer Advisory Board; and committees of the Institute of Medicine. He is a member of the Institute of Medicine and he chairs the NRC Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. Dr. Samet received his MD from the University of Rochester, School of Medicine and Dentistry.
Scott Bartell
University of California, Irvine

Scott Bartell is associate professor in public health, statistics, and epidemiology at the University of California, Irvine. His research interest is environmental-health methodology with applications in environmental epidemiology, exposure science, and risk assessment. His recent projects include epidemiologic analysis of particulate-matter exposure and arrhythmia in the Cardiovascular Health and Air Pollution Study, linkage of fate and transport models and a pharmacokinetic model for perfluorooctanoic acid with data from the C8 Health Project, and development of statistical methods for biomarker-based exposure estimation and for epidemiologic analysis of aggregated data. He has served on a variety of scientific advisory committees for the National Research Council, the Environmental Protection Agency, the Centers for Disease Control and Prevention, the National Institute of Environmental Health Sciences, and the Department of Energy. Dr. Bartell earned a PhD in epidemiology and an MS in statistics from the University of California, Davis and an MS in environmental health from the University of Washington.
Lisa Bero
University of California, San Francisco

Lisa Bero is a professor in the Department of Clinical Pharmacy and Institute for Health policy Studies of the University of California, San Francisco. She is also the director of the San Francisco Branch of the United States Cochrane Center. Her research interests include methods for meta-analysis and critical appraisal of research, academic–industry relations, pharmaceutical outcomes assessment, pharmacology, tobacco-control policy, and translation of research into policy. Dr. Bero is a member of the World Health Organization Guideline Review Committee and the Advisory Committee on Health Research of the Pan American Health Organization. In addition, she is a member of the Institute of Medicine Board on Health Care Services. Dr. Bero received a PhD in pharmacology and toxicology from Duke University.
Ann Bostrom
University of Washington

Ann Bostrom is a professor of public affairs at the Daniel J. Evans School of Public Affairs of the University of Washington. Her research focuses on risk perception, communication, and management and on environmental policy and decision-making under uncertainty. Dr. Bostrom has been an author of or contributor to numerous publications, including Risk Assessment, Risk Communication: A Mental Models Approach, Modeling and Decision Support: Strategic Directions, and reports for the Environmental Protection Agency Science Advisory Board and Board of Scientific Counselors. She also serves as an associate editor or a risk communication editor for the journals Risk Analysis, Journal of Risk Research, and Human and Ecological Risk Assessment. Dr. Bostrom is a member of the Policy Council of the Association for Public Policy Analysis and Management and a member of the Society for Judgment and Decision Making, the American Association for the Advancement of Science, and current president and fellow of the Society for Risk Analysis. She has served on several National Research Council committees, including the current Committee on Use of Emerging Science for Environmental Health Decisions. Dr. Bostrom received a PhD in public policy analysis from Carnegie Mellon University.
Kay Dickersin
Johns Hopkins Bloomberg School of Public Health

Kay Dickersin is a professor and director of clinical trials at the Johns Hopkins University Bloomberg School of Public Health. Her major research interests are related to randomized clinical trials, trial registers, systematic reviews and meta-analysis, publication bias, peer review, evidence-based health care, and comparative-effectiveness research. Dr. Dickersin has also conducted studies in such fields as women's health, eyes and vision, and surgery. She is director of the US Cochrane Center, one of 14 centers worldwide participating in the Cochrane Collaboration, which aims to help people to make well-informed decisions about health by preparing, maintaining, and promoting the accessibility of systematic reviews of available evidence on the benefits and risks associated with health care. She has served as a member of several National Research Council committees and is a member of the Institute of Medicine. Dr. Dickersin received a PhD in epidemiology from the Johns Hopkins University School of Hygiene and Public Health.
David C. Dorman
North Carolina State University

David C. Dorman is a professor of toxicology in the Department of Molecular Biosciences of North Carolina State University. The primary objective of his research is to provide a refined understanding of chemically induced neurotoxicity in laboratory animals that will lead to improved assessment of potential neurotoxicity in humans. Dr. Dorman's research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfactory in military working dogs. He served as a member of the National Research Council Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents, as member and chair of two Committees on Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants and the Committee to evaluate Potential Health Risks from Recurrent Lead Exposure to DOD Firing Range Personnel, and as a member of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde. He received his DVM from Colorado State University. He completed a combined PhD and residency program in toxicology at the University of Illinois at Urbana-Champaign and is a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology.
David L. Eaton
University of Washington

David L. Eaton is a professor of environmental and occupational health sciences and associate vice provost for research at the University of Washington (UW). He also serves as the director of the National Institute of Environmental Health Sciences Center for Ecogenetics and Environmental Health at UW. He has previously held several other UW positions, including toxicology program director and associate chairman in the Department of Environmental Health and associate dean for research in the School of Public Health. Dr. Eaton maintains an active research and teaching program that is focused on the molecular basis of environmental causes of cancer and how human genetic differences in biotransformation enzymes may increase or decrease individual susceptibility to chemicals in the environment. He has published over 150 scientific articles and book chapters in toxicology and risk assessment. Nationally, he has served on the Board of Directors and as treasurer of the American Board of Toxicology, as secretary and later as president of the Society of Toxicology, as a member of the Board of Directors and as vice-president of the Toxicology Education Foundation, and as a member of the Board of Trustees of the Academy of Toxicological Sciences. Dr. Eaton is a member of the Institute of Medicine and has served on several National Research Council committees, currently as a member of the Committee on Science for EPA's Future. He is an elected fellow of the American Association for the Advancement of Science and the Academy of Toxicological Sciences. Dr. Eaton earned a PhD in pharmacology from the University of Kansas Medical Center.
Joe G. Garcia
University of Illinois at Chicago

Joe G. Garcia is the vice president for health affairs at the University of Illinois Hospital & Health Sciences. He is internationally recognized for his expertise in the genetic basis of lung disease and the prevention of and treatment for inflammatory lung injury. Dr. Garcia’s research focuses on understanding the biochemical and molecular basis of lung inflammation, especially vascular leak, in which blood cells and fluid escape from the small vessels and cause edema in the surrounding tissues, especially the lungs. He is a past president of the Central Society for Clinical Research and a member of the Board of Directors of the American Thoracic Society and has been a member or chairman of several committees of the National Institutes of Health. In addition, Dr. Garcia is a member of the Institute of Medicine, the Association of American Physicians, and the American Society of Clinical Investigation. He received an MD from the University of Texas Southwestern Medical Center.
Miguel Hernan
Harvard School of Public Health

Miguel Hernán is a professor of epidemiology and biostatistics at the Harvard University School of Public Health and affiliated faculty at the Harvard-MIT Division of Health Sciences and Technology. His research is focused on methods for causal inference, including comparative effectiveness of policy and clinical interventions. Dr. Hernán and his collaborators combine observational data, mostly untestable assumptions, and statistical methods to emulate hypothetical randomized experiments. His research group emphasizes the need to formulate well-defined causal questions and the use of analytic approaches whose validity does not require assumptions that conflict with current subject-matter knowledge. Dr. Hernán in an editor of the journal Epidemiology and has served on the Institute of Medicine Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. He received an MD from the Universidad Autónoma de Madrid in Spain.
James S. House
University of Michigan

James S. House is Angus Campbell Distinguished University Professor of Survey Research, Public Policy, and Sociology at the University of Michigan. His research interests include social psychology, political sociology, social structure and personality, psychosocial and socioeconomic factors in health, survey research methods, and American society. Dr. House has worked in sociology and social epidemiology to understand the effects of broader social structures and processes on people’s attitudes, behavior, well-being, and especially health. His and his colleagues' research has helped to demonstrate the adverse effects of occupational and other forms of stress on health and how social relationships and supports can buffer or mitigate the deleterious health effects of stress and promote health more generally. Over the past two decades he has focused on describing and understanding social disparities in health over time and the life course, especially by socioeconomic position. Dr. House is a member of the American Academy of Arts and Sciences, the National Academy of Sciences, and the Institute of Medicine. He has served on the National Research Council Panel on Race, Ethnicity, and Health in Later Life. Dr. House received a PhD in social psychology from the University of Michigan.
Margaret M. MacDonell
Argonne National Laboratory

Margaret M. MacDonell is a program manager in the Environmental Science Division of Argonne National Laboratory. She conducts integrated environmental health analyses, primarily for federal agencies. She has professional interests in cumulative impact and risk; integrated environmental fate, exposure, and health effect analyses for multiple stressors including chemical mixtures, nanomaterials, and other hazards (including related to energy development); integrated impact analyses for sustainability; and community involvement for environmental health protection. Dr. MacDonell developed risk training workshops for environmental managers and practitioners, including people in state agencies and tribal nations. She collaborated with the Environmental Protection Agency National Homeland Security Research Center to develop acute and short-term exposure advisories for chemical, radiologic, and biologic contaminants released to drinking water and into buildings. She serves on two National Research Council committees: the Committee on Toxicology and the Committee on Acute Exposure Guideline Levels. Dr. MacDonell received a PhD in environmental health engineering from Northwestern University.
Richard P. Scheines
Carnegie Mellon University

Richard P. Scheines is a professor and the head of philosophy at Carnegie Mellon University. His research focuses on causal discovery, specifically the problem of learning about causation from statistical evidence. Dr. Scheines also works in building and researching the effectiveness of educational software, ranging from intelligent proof tutors to virtual causality laboratories to a full-semester course on causal and statistical reasoning. Because of that work, he has a courtesy appointment in the Human-Computer Interaction Institute at Carnegie Mellon. He has served on two National Research Council committees. Dr. Scheines received a PhD in the history and philosophy of science from the University of Pittsburgh.
Leonard M. Siegel
Center for Public Environmental Oversight

Leonard M. Siegel is director of the Center for Public Environmental Oversight, a project of the Pacific Studies Center that facilitates public participation in the oversight of military environmental programs, federal facilities cleanup, and brownfield revitalization. He is one of the environmental movement’s leading experts in military-facility contamination, community oversight of cleanup, and the vapor-intrusion pathway. For his organization, he runs two Internet newsgroups: the Military Environmental Forum and the Brownfields Internet Forum. He is a member of the Interstate Technology and Regulatory Council Munitions Response Work Team, the California Department of Toxic Substances Control External Advisory Group, and the Moffett Field (formerly Moffett Naval Air Station) Restoration Advisory Board. He has served on several committees of the National Research Council, currently as a member of the Committee on the Future Options for Management in the Nation's Subsurface Remediation Effort. Mr. Siegel studied physics at Stanford University.
Robert B. Wallace
The University of Iowa

Robert B. Wallace is a professor and director of the Center on Aging in the Departments of Epidemiology and Internal Medicine at the University of Iowa. His current research interests include the epidemiology and prevention of aging-related chronic conditions, such as disabling illnesses of older persons, including arthritis, cancer, cardiovascular diseases, and dementia; clinical trials; disease prevention; epidemiology; health promotion; preventive medicine; and public health. Dr. Wallace is a member of the Institute of Medicine (IOM), chairs the IOM Board on the Health of Select Populations, and is a member. Dr. Wallace received an MD from Northwestern University.
Yiliang Zhu
University of South Florida

Yiliang Zhu is a professor in the Department of Epidemiology and Biostatistics of the University of South Florida College of Public Health. He is also director of the college’s Center for Collaborative Research. His current research is focused on quantitative methods in health risk assessment, including modeling of biological systems via pharmacokinetics and pharmacodynamics, dose-response modeling, benchmark-dose methods, and uncertainty quantification. He also conducts research in disease surveillance, health-outcome evaluation, and impact assessment of healthcare systems and policies in rural China. Dr. Zhu was a member of the National Research Council Committee on EPA’s Exposure and Human Health Assessment of Dioxin and Related Compounds, Committee on Tetrachloroethylene, and Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde. He received a PhD in statistics from the University of Toronto.

Committee Membership Roster Comments

Note:

7/31/2012: Lauren Zeise was provisionally appointed to the committee but will not be serving

Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  -

Agenda
This meeting will be closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Scott Bartell (via teleconference)
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
Joe Garcia
Miguel Hernán
James House
Margaret MacDonell
Richard Scheines
Leonard Siegel
Robert Wallace
Yiliang Zhu

The following topics were discussed in the closed sessions:

1) The draft report and committee findings and recommendations.
2) Report review process and potential reviewers.
3) Committee assignments and report review schedule.


The following materials (written documents) were made available to the committee in the closed sessions:

60. Email and attachment from Martin Gehlhaus, EPA, to Ellen Mantus, regarding IRIS Activities of Interest, received on September 9, 2013.

61. Comments from Jennifer Sass, NRDC, sent to Ellen Mantus, regarding the NRDC’s comments on the OHAT systematic review process, received on September 16, 2013.

62. Email and two attachments from Ivan Rusyn, University of North Carolina, sent to Ellen Mantus, regarding a manuscript and poster that will be presented on October 29, 2013 at the OpenTox meeting in RTP, received on October 27, 2013.


Date of posting of Closed Session Summary:
November 11, 2013
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  -
Contact Email:  -
Contact Phone:  -

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Scott Bartell
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
James House
Margaret MacDonell
Richard Scheines
Leonard Siegel
and Robert Wallace.

The following topics were discussed in the closed sessions:

1) Draft report materials.
2) EPA materials on revisions to IRIS process.
3) Schedule and agenda for final meeting.
4) Committee assignments and report review schedule.

The following materials (written documents) were made available to the committee in the closed sessions:

52. Email and attachment from Nancy Beck, American Chemistry Council, to Ellen Mantus, regarding EPA’s January 30th 2013 Submission to the National Research Council IRIS Committee. Received on June 24, 2013.

53. Email and attachment from Teresa K. Woodruff, The Endocrine Society, to Ellen Mantus, regarding the Review of EPA's draft paper State of the Science on Nonmonotonic Dose Response PIN: DELS-BEST-12-06, dated July 22, 2013. Received on July 26, 2013.

54. Email and attachment from Vincent Cogliano, EPA, to Ellen Mantus, regarding IRIS: EPA announces new process enhancements, received on July 31, 2013.

55. Email and in press paper from Lorenz Rhomberg, Gradient, titled A Survey of Frameworks for Best Practices in Weight-of-Evidence Analyses, to Ellen Mantus, received on August 6, 2013.

56. Email and three attachments from Vincent Cogliano, EPA, to Ellen Mantus, regarding IRIS: Response to Committee inquiries, received on August 20, 2013.

57. Email and one attachment from Vincent Cogliano, EPA, to Ellen Mantus, regarding IRIS: Response to Committee inquiries, part 2 (Benzo[a]pyrene), received on August 20, 2013.

58. Email and one attachment from Julie Goodman, Gradient Corporation, to Ellen Mantus, regarding Evaluation of NAAQS causal framework, received on August 23, 2013.

59. Email and three attachments from Nancy Beck, American Chemistry Council, to Ellen Mantus, regarding Information for the NAS IRIS committee, received on August 27, 2013.


Date of posting of Closed Session Summary:
September 09, 2013
Publication(s) resulting from the event:

-


Location:

J. Erik Jonsson Woods Hole Center
314 Quissett Ave.
Woods Hole, Massachusetts
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  Craig Philip
Contact Email:  cphilip@nas.edu
Contact Phone:  202-334-1942

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Scott Bartell (via teleconference)
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
Joe Garcia
Miguel Hernán
James House
Margaret MacDonell
Richard Scheines
Leonard Siegel
and Robert Wallace.

The following topics were discussed in the closed sessions:

1) Draft report materials.
2) EPA materials on revisions to IRIS process.
3) Schedule and agendas for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

49. Email and letter from Richard Becker, ACC, to Ellen Mantus. Received on April 11, 2013.

50. Email from Kristina Thayer, NTP, to Ellen Mantus, regarding the posting of draft systematic review protocols. Received on April 9, 2013.

51. Email and letter from Richard A. Becker, ACCl, to Ellen Mantus, regarding Best Practices for Weight of Evidence Evaluations. Received on May 24, 2013.


Date of posting of Closed Session Summary:
June 18, 2013
Publication(s) resulting from the event:

-


Location:

National Academy of Sciences Building
2101 Constitution Ave NW, Washington, DC 20418
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  Craig Philip
Contact Email:  cphilip@nas.edu
Contact Phone:  202-334-1942

Agenda
***We have reached our registration limit. Only teleconference requests are now being accepted. All registrations will close on Tuesday at 4pm***

*If you are not able to attend the workshop in person we have secured a teleconference line for guests to listen in (Please note that presentations/slides will not be available for teleconference guests during the workshop). Please contact Craig Philip - cphilip@nas.edu for teleconference information.

WORKSHOP AGENDA ON WEIGHT OF EVIDENCE
NATIONAL RESEARCH COUNCIL
COMMITTEE TO REVIEW THE IRIS PROCESS

March 27-28, 2013
National Academy of Sciences, Lecture Room
2101 Constitution Ave., N.W.
Washington, DC 20418
PH: 202-334-1578 / FAX 202-334-2752

FIRST DAY OF WORKSHOP – MARCH 27, 2013


8:00 Welcome to Workshop
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


ASSEMBLING THE EVIDENCE

This session will address approaches to identifying evidence on agents being considered in IRIS assessments. It will cover methods for searching literature and other data bases. The session will also consider the complicating issues of publication bias, “the grey literature,” selective publication of model results, and access to primary data. A further major set of topics include the use of systematic approaches for characterizing study quality, methods for qualitatively and quantitatively assessing heterogeneity across studies, and use of quantitative synthesis (meta-analysis). An additional topic, potentially relevant to some assessments, is whether all assessments need a comprehensive review of the literature.

8:15 Introduction and Overview of Session
Lisa Bero
Member, Committee to Review the IRIS Process
Professor, Department of Clinical Pharmacy
University of California, San Francisco

8:25 Systematic Review of Animal Studies and Approaches for Characterizing Study Quality
Malcolm MacLeod
Professor of Neurology and Translational Neuroscience
University of Edinburgh

8:40 Systematic Review of Human Studies and Approaches for Characterizing Study Quality
Karen Robinson
Associate Professor
Medicine, Epidemiology, and Health Policy and Management
Johns Hopkins Medical Institutions

8:55 Development, Maintenance, and Use of an Air Pollution Data Base
Richard Atkinson
Senior Lecturer in Epidemiology
St. George’s University of London

9:10 Panel Discussion with Speakers on Assembling the Evidence

Key Questions

(1) Do IRIS assessments necessarily require full systematic reviews? (2) How might assessment of risk of bias differ between studies of chemicals and studies of other interventions, such as drugs? (3) What are the implications of heterogeneity of findings for risk relationships? (4) What approaches should be used for assembling different types of evidence, such as epidemiological and toxicological? (5) How can mechanistic information be systematically identified?

10:10 BREAK



MECHANISM AND MODE OF ACTION

There is a pressing need to improve efficiency in the risk-assessment process and incorporate high-throughput technology in evaluating the potential health effects of chemicals. Several efforts are underway by EPA to improve chemical risk assessment. For example, EPA’s high-throughput testing program (ToxCast) is designed to identify chemicals with the greatest potential risk to human health. EPA’s IRIS program is charged with evaluating and integrating these and other multiple types of evidence regarding potential adverse effects of environmental contaminants on human health: mechanistic studies, animal bioassays, and human studies. This panel will discuss current and future use of data on mechanism and mode of action in weight-of-evidence considerations. Specific topics of interest are (a) evaluation of strength-of-evidence related to mechanisms, (b) the use and interpretation of high-throughput toxicity screening data, and (c) application of genomic dose-response data to chemical risk assessment. Consideration of application of mechanistic data to cancer and noncancer chemical risk assessment within IRIS assessments is of overarching interest.


10:30 Introduction and Overview of Session
David Dorman
Member, Committee to Review the IRIS Process
Professor of Toxicology, College of Veterinary Medicine
North Carolina State University




10:40 Use of High-Throughput and High-Data-Content Technologies in Chemical Risk Assessment
Rusty Thomas
Director, Institute for Chemical Safety Sciences
The Hamner Institutes for Health Sciences

11:00 Panel Discussion of High-Throughput Data for Determining Mechanism or Mode of Action

Panelists: David Schwartz, Chair of Medicine, Professor of Medicine and Immunology, University of Colorado; George Leikauf, Professor of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh; Rusty Thomas, Director, Institute for Chemical Safety Sciences, The Hamner Institutes for Health Sciences; Joe Rodricks, Principal, ENVIRON; and Thomas Hartung, Professor and Doerenkamp-Zbinden Chair for Evidence-based Toxicology,
Director Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health

Key Questions

Topic 1: How will findings from new high-throughput assays be used? Can data from high-throughput assays replace more traditional apical end points that are examined in animal toxicity studies? How can dose-dependent changes in mechanisms identified from high-throughput assays be incorporated into chemical risk assessments? How can pharmacokinetic and similar data inform the interpretation of high-throughput screening assays?

Topic 2: How should mechanistic information be incorporated into IRIS assessments? How can the science be advanced to improve qualitative and quantitative application of mechanistic information? What are the evidence criteria for concluding that a mechanism is established as relevant to an agent and outcome?

12:00 BREAK FOR LUNCH



INTEGRATION OF DATA

EPA’s IRIS program is charged with evaluating and integrating multiple types of evidence regarding potential effects of environmental contaminants on human health: mechanistic studies, animal bioassays, and human studies. Assessments are often challenging due to sparse evidence, the use of relatively high doses in experimental bioassays, unclear toxicological mechanisms of action, and unmeasured co-exposures and other threats to validity in observational designs. This session will address qualitative and quantitative strategies for integrating evidence of different types in human health risk assessments.

1:00 Introduction and Overview of Session
Scott Bartell
Member, Committee to Review the IRIS Process
Associate Professor, Program in Public Health
University of California, Irvine

1:10 Qualitative and Quantitative Methods for Integrating Evidence
Duncan Thomas
Professor and Verna Richter Chair in Cancer Research, Keck School of Medicine
University of Southern California


1:30 Panel Discussion on Integrating Various Data

Panelists: Steve Goodman, Professor of Medicine and Epidemiology, Stanford University; Kristina Thayer, Director, Office of Health Assessment and Translation, National Toxicology Program; Duncan Thomas, Professor and Verna Richter Chair in Cancer Research, Keck School of Medicine, University of Southern California; Tracey Woodruff, Professor and Director, Program on Reproductive Health and the Environment, University of California, San Francisco; and Lauren Zeise, Deputy Director for Scientific Affairs, Office of Environmental Health Hazard Assessment, California EPA

Key Questions

Topic 1: Hypothetical mechanisms or modes of action have been proposed for some toxicants, largely based on research in animal models. Consequently, it might be difficult to identify or exclude additional mechanisms for toxic effects in humans. Should mechanistic information be used in a qualitative manner, such as in Hill's biological “plausibility” criterion? Can information from observational or clinical studies on intermediate end points related to mechanisms be helpful? How can mechanistic understanding best be reflected in dose-response model selection or parameter estimation?

Topic 2: How should evidence of toxicity from high-dose animal studies be weighed against null findings from one or more epidemiologic studies at lower exposures? What level of epidemiologic evidence would be sufficient to dismiss a toxic effect in animals as irrelevant to humans? How can dose-response relationships be combined from different types of research, for example, animal bioassay and epidemiological?

Topic 3: Should positive epidemiologic studies with weaker designs (for example, ecological studies, or studies with unmeasured known confounders) or with positive but non-significant associations contribute to the weight of evidence, or should they be considered only as hypothesis generating?

2:30 BREAK



CAUSALITY

The IRIS assessments evaluate hazard, specifically whether the chemical of concern is a cause of one or more adverse outcomes. The goal of the causal criteria session is to consider the best methods available for systematically evaluating the evidence from individual studies with respect to whether, and to what degree, a chemical causes a particular health outcome, and for combining the evidence in individual studies into an overall judgment as to the likelihood of a causal relationship. Specific goals of the session include (1) considering the utility of existing causal criteria outlined in the most recent IRIS documents; (2) comparing causal assessment methods used by other national and international organizations, with the potential goals of elaborating new guidelines for assessing strength of evidence for causation and of achieving some harmonization across agencies; and (3) considering whether the Hill “criteria” are still useful as guides to synthesizing the overall evidence for causation, or whether alternative criteria or guidelines might be an improvement on approaches developed almost half a century ago.

3:00 Introduction and Overview of Session
Richard Scheines
Member, Committee to Review the IRIS Process
Professor and Head of Philosophy Department
Carnegie Mellon University

3:10 The Role of Mechanism in Causal Assessments and the State of Bradford-Hill
Steve Goodman
Professor of Medicine and Epidemiology
Stanford University

3:25 Application of Causal Methods to Assess Effects of Chemical Exposures in Practice
Lauren Zeise
Deputy Director for Scientific Affairs
Office of Environmental Health Hazard Assessment
California EPA

3:40 Comparing Weight-of-Evidence Frameworks for Causation
Lorenz Rhomberg
Principal
Gradient

3:55 Panel Discussion with Speakers on Causal Methods

Key Questions

Should the approach to causal inference within EPA guidelines be revised? Are the long-standing causal criteria still useful, given the range of evidence considered in IRIS assessments? How should causal judgments be made in practice? How can they be most useful for practitioners?

4:55 Opportunity for Public Comment

5:30 ADJOURN FIRST DAY OF WORKSHOP




SECOND DAY OF WORKSHOP – MARCH 28, 2013


8:00 Welcome to Concluding Session of Workshop
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

8:15 Putting the Pieces Together: A Case Study
Tracey Woodruff
Professor and Director
Program on Reproductive Health and the Environment
University of California, San Francisco

8:45 Workshop Discussion: From Start to Finish – Systematic Review and Evidence Integration
Speakers, Panelists, and Committee Members


METHODS FOR CHARACTERIZING AND COMMUNICATING UNCERTAINTY

One of the primary aims of systematic reviews is to characterize and communicate the state-of-evidence on a specific topic. Absence of evidence and uncertainties may be characterized using different approaches that range from implicit characterization (qualitative discussion, unexplained variance) to explicit and quantitative characterization. In most cases, communicating uncertainty qualitatively or quantitatively should be an intrinsic element of such efforts. Numerical, verbal, and graphical tools are all widely used to characterize and communicate uncertainty, but with varying success. In this session, methods for characterizing and communicating uncertainties in the IRIS assessment will be considered.

9:15 Introduction and Overview of Session
Ann Bostrom
Member, Committee to Review the IRIS Process
Professor, Daniel J. Evans School of Public Affairs
University of Washington

9:25 Characterizing Uncertainty
Jay Kadane
Leonard J. Savage University Professor of Statistics, Emeritus
Carnegie Mellon University

9:45 How the Public Interprets Uncertainty Communication: Some Lessons from the IPCC
David Budescu
Anne Anastasi Professor of Psychometrics and Quantitative Psychology
Fordham University

10:00 Panel Discussion on Uncertainty

Panelists: Tim Lash, Professor, Rollins School of Public Health, Emory; Chris Frey, Distinguished University Professor, North Carolina State University; David Budescu, The Anne Anastasi Professor of Psychometrics and Quantitative Psychology, Fordham University; Jay Kadane , Leonard J. Savage University Professor of Statistics, Emeritus, Carnegie Mellon University; and Thomas Wallsten, Professor, Department of Psychology, University of Maryland

Key Questions

What approaches would enhance the consideration and presentation of uncertainty in IRIS assessment? What attributes of users and uses of IRIS should guide methods for characterizing uncertainties in IRIS assessments? What do we know about tools that are readily available for use in quantifying uncertainty in IRIS?

10:45 BREAK





USE OF EXPERT JUDGMENT

Expert judgment is used in systematic review processes and throughout IRIS assessments, as discussed in the earlier sessions at this workshop. Expert judgment is also used in risk analysis to fill gaps when data are unavailable. Although it is an inherent component of IRIS assessments, this has not been explicitly acknowledged. In this session, the use of expert judgment in the IRIS assessment will be considered, identifying those points in the review and assessment process where expert judgment is important. The session will consider processes for using expert judgment as discussed throughout the workshop in previous sessions and in risk assessment, including elicitation and Delphi approaches.

11:00 Introduction and Overview of Session
Ann Bostrom
Member, Committee to Review the IRIS Process
Professor, Daniel J. Evans School of Public Affairs
University of Washington

11:15 Panel Discussion on Expert Judgment

Panelists: Tim Lash, Professor, Rollins School of Public Health, Emory; Chris Frey, Distinguished University Professor, North Carolina State University; David Budescu, The Anne Anastasi Professor of Psychometrics and Quantitative Psychology, Fordham University; Jay Kadane , Leonard J. Savage University Professor of Statistics, Emeritus, Carnegie Mellon University; and Thomas Wallsten, Professor, Department of Psychology, University of Maryland

[NOTE: All invited workshop participants are urged to participate in this particular discussion.]

Suggested topics to address by the panel: (a) elicitation techniques (b) understanding the specificity of expertise and to what extent interdisciplinary expertise is required or possible, (c) opportunities (when and where) for the value of expert judgments in IRIS and (d) limitations (including expert bias) on the value of expert judgments in IRIS.

Key Questions

What are best practices for identifying appropriate expertise and eliciting expert judgments, what is the evidence for their effectiveness, and how could they inform the IRIS process? What types of biases in expert judgments might affect IRIS assessments, and how could these be mitigated?

12:15 Opportunity for Public Comment

12:30 ADJOURN WORKSHOP

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Scott Bartell
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
Joe Garcia
Miguel Hernán
James House
Margaret MacDonell
Richard Scheines
Leonard Siegel
Robert Wallace
and Yiliang Zhu.

The following topics were discussed in the closed sessions:

1) Materials presented during the workshop.
2) Need for additional background material and open sessions.
3) Draft report outline.
4) Schedule and agendas for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

25. Letter with appendices submitted by Richard Becker and Kimberly Wise, American Chemistry Council, to Ellen Mantus on December 27, 2012.

26. Letter and book chapter submitted by James W. Conrad, Jr., Conrad Law & Policy Counsel, to Ellen Mantus dated January 14, 2013.

27. Email from Vince Cogliano, EPA, to Ellen Mantus with two attachments regarding Status of Implementation of Recommendations and Chemical Specific Examples, received on January 30, 2013.

28. Email and three references from Lorenz Rhomberg, Principal, Gradient, sent to Ellen Mantus. Received February 26, 2013.

29. Cox Jr., L.A. 2013. Improving causal inferences in risk analysis. Forthcoming in Risk Analysis. From Tony Cox, Cox Associates and University of Colorado. Received March 13, 2013.

30. Email and attachment regarding a request for a public meeting on the January 30, 2013 IRIS submissions sent from Richard Becker and Kimberly Wise, ACC, to Ellen Mantus. Received March 25, 2013.

31. Email and three attachments regarding Data Evaluation of Toxicology Studies sent from Richard Becker, ACC, to Ellen Mantus. Received March 26, 2013.

32. Committee to Review the IRIS Process Workshop on Weight of Evidence Introduction. A PowerPoint presentation at the Workshop on Weight of Evidence by Jonathan Samet, chair, Committee to Review the IRIS Process, on March 27, 2013, in Washington, DC.

33. Mechanism and Mode of Action. A PowerPoint presentation at the Workshop on Weight of Evidence by David Dorman, member, Committee to Review the IRIS Process, on March 27, 2013, in Washington, DC.

34. Causality. A PowerPoint presentation at the Workshop on Weight of Evidence by Richard Scheines, member, Committee to Review the IRIS Process, on March 27, 2013, in Washington, DC.

35. Integrating Toxicity Data from Multiple Species/Endpoints. A PowerPoint presentation at the Workshop on Weight of Evidence by Scott Bartell, member, Committee to Review the IRIS Process, on March 27, 2013, in Washington, DC.

36. Mechanism/Mode of Action (MOA) Information in Risk Assessment. A PowerPoint presentation at the Workshop on Weight of Evidence by Joseph Rodricks, ENVIRON, on March 27, 2013, in Washington, DC.

37. Communicating Uncertainty: Some Lessons from the IPCC. A PowerPoint presentation at the Workshop on Weight of Evidence by David Budescu, Fordham University, on March 28, 2013, in Washington, DC.

38. Qualitative and Quantitative Methods for Integrating Evidence. A PowerPoint presentation at the Workshop on Weight of Evidence by Duncan Thomas, USC, on March 27, 2013, in Washington, DC.

39. Characterizing Uncertainty in Twenty Minutes. A PowerPoint presentation at the Workshop on Weight of Evidence by Joseph (Jay) Kadane, Carnegie Mellon University, on March 28, 2013, in Washington, DC.

40. Comparing Weight-of-Evidence Frameworks for Causation. A PowerPoint presentation at the Workshop on Weight of Evidence by Lorenz Rhomberg, Gradient, on March 27, 2013, in Washington, DC.

41. Systematic Review of Animal Studies and Approaches for Characterising Study Quality. A PowerPoint presentation at the Workshop on Weight of Evidence by Malcolm Macleod, University of Edinburgh, on March 27, 2013, in Washington, DC.

42. Development, Maintenance, and Use of an Air Pollution Data Base. A PowerPoint presentation at the Workshop on Weight of Evidence by Richard Atkinson, St. George’s University of London, on March 27, 2013, in Washington, DC.

43. Assembling Evidence: Systematic Approach to Identification and Evaluation. A PowerPoint presentation made at the Workshop on Weight of Evidence by Karen Robinson, Johns Hopkins University, on March 27, 2013, in Washington, DC.

44. Use of High-Throughput and High-Data-Content Technologies in Chemical Risk Assessment. A PowerPoint presentation made at the Workshop on Weight of Evidence by Russell Thomas, The Hamner Institutes for Health Sciences, on March 27, 2013, in Washington, DC.

45. Bradford-Hill Criteria and Causal Mechanisms. A PowerPoint presentation made at the Workshop on Weight of Evidence by Steven Goodman, Stanford, on March 27, 2013, in Washington, DC.

46. Putting the Pieces Together. Navigation Guide Case Study: A Systematic Review of Human and Non-Human Evidence for PFOA and Fetal Growth. A PowerPoint presentation made at the Workshop on Weight of Evidence by Tracy Woodruff, UCSF, on March 28, 2013, in Washington, DC.

47. Application of Causal Methods to Assess Effects of Chemical Exposures in Practice. A PowerPoint presentation made at the Workshop on Weight of Evidence by Lauren Zeise, California EPA, on March 27, 2013, in Washington, DC.

48. Email from Chris Frey, North Carolina State University, to Ellen Mantus, with 6 attachments. Received on March 30, 2013.


Date of posting of Closed Session Summary:
April 09, 2013
Publication(s) resulting from the event:

-


Location:

Arnold and Mabel Beckman Center
100 Academy Way, Irvine, CA 92617
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  Craig Philip
Contact Email:  cphilip@nas.edu
Contact Phone:  202-334-1942

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
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

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
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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

Contact Name:  Craig Philip
Contact Email:  cphilip@nas.edu
Contact Phone:  202-334-1942

Agenda
*Online registration of the meeting is now closed. If you would like to attend the meeting you will have to register at the Keck Center at the start of the open session meeting.*

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

Open Session: September 17, 2012
National Academies Keck Center, Room 201
500 Fifth Street, NW
Washington, DC 20001
PH: 202-334-2017 / FAX 202-334-2752

AGENDA

1:00 Purpose of Open Session and Introduction of Committee Members
Jon 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

1:15 EPA’s IRIS Program
Kenneth Olden
Director of the National Center for Environmental Assessment
U.S. Environmental Protection Agency

1:30 Recent Changes in IRIS Assessment Development and Anticipated Future Changes
Vincent Cogliano
Acting Director of the Integrated Risk Information System Program
U.S. Environmental Protection Agency

2:00 Workshop on Weight of Evidence – Discussion Session

EPA Staff and Committee to Review the IRIS Process

3:00 Open Microphone – Comments from the Audience

4:00 END PUBLIC SESSION

Note: If you are not able to attend the public session in person and would like to participate via teleconference, please contact Craig Philip at cphilip@nas.edu
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Scott Bartell
Lisa Bero
Ann Bostrom
Kay Dickersin
David Dorman
David Eaton
Joe Garcia
Miguel Hernán
James House
Margaret MacDonell
Richard Scheines
Leonard Siegel
Robert Wallace (via teleconference)
Yiliang Zhu

The following topics were discussed in the closed sessions:

1) Standard NRC discussion of policies, procedures, bias, and conflict of interest.
2) Committee’s statement of task and its approach to its task.
3) Information presented in the open session and submitted to the committee.
4) Schedule and agendas for future meetings and weight-of-evidence workshop.


The following materials (written documents) were made available to the committee in the closed sessions:

1. EPA’s Integrated Risk Information System Program: Progress Report and Report to Congress. Sent to Ellen Mantus from Norman Birchfield, EPA. Received on August 20, 2012.

2. EPA’s Path Forward for the Integrated Risk Information System Program. Sent to Ellen Mantus from Norman Birchfield, EPA. Received on August 20, 2012.

3. Appendix E: Documentation of Implementation of the 2011 National Research Council Recommendations. From EPA 2012: Toxicological Review of Ammonia. Sent to Ellen Mantus from Norman Birchfield, EPA. Received on August 20, 2012.

4. Appendix D: Documentation of Implementation of the 2011 National Research Council Recommendations. From EPA 2012: Toxicological Review of Trimethylbenzene. Sent to Ellen Mantus from Norman Birchfield, EPA. Received on August 20, 2012.

5. Modernizing and Refocusing Human Health Risk Assessment. A PowerPoint presentation to the Committee to Review the IRIS Process by Dr. Kenneth Olden, EPA, on September 17, 2012, in Washington, DC.

6. Recent Changes in IRIS Assessment Development and Anticipated Future Changes. A PowerPoint presentation to the Committee to Review the IRIS Process by Dr. Vincent Cogliano, EPA, on September 17, 2012, in Washington, DC.

7. Letter from Kimberly Wise and Rick Becker, American Chemistry Council, to Ellen Mantus, dated September 13, 2012, with two appendices.

8. Notes for NRC Committee Meeting on IRIS from Richard Belzer, Regulatory Checkbook. Comments made to the Committee to Review the IRIS Process on September 17, 2012, in Washington, DC.

9. Extended Remarks by Charles Elkins made to the Committee to Review the IRIS Process on September 17, 2012, Washington, DC.

10. Comments for Review of the IRIS Process, submitted by Angus Macbeth, Sibley Austin, LLP, to Ellen Mantus on September 24, 2012.


Date of posting of Closed Session Summary:
September 25, 2012
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office