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Project Information

Project Information


Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants


Project Scope:


An ad hoc committee will address scientific issues and provide guidance on the conduct of controlled human-exposure studies designed to inform policy decisions and set air-pollutant standards to protect public health.  The committee will consider EPA’s Office of Inspector General report titled Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects, which recommends improvements to EPA’s conduct of studies and outlines how the agency intends to address the recommendations.  Relevant issues and questions for the committee to address include the following:

 ·         EPA has performed controlled human-exposure studies to help understand exposure to and potential health effects of common air pollutants, such as particulate matter.  To what extent have such studies been valuable to inform and reduce uncertainties in setting pollutant standards?  Is it warranted to continue to conduct controlled human-exposure studies as part of EPA’s larger research agenda for air pollutants?

·         The committee will assess the potential health risks to test subjects who participated in recent studies of air pollutants at EPA’s clinical research facility and comment on the degree of actual risk imposed by the exposures in those studies.

·         If the committee supports continued conduct of human exposure studies, it will provide further guidance in the following areas:

o   Methods for estimating levels of risk in controlled human-exposure studies, drawing from relevant approaches used in Phase I clinical drug trials.

o   A template to characterize reasonably foreseeable risks, in terms of the nature, frequency, and magnitude of possible risks, which could be used in obtaining informed consent from potential study participants.  The literature on “challenge studies” should be considered in the design of the template, if applicable.

Status: Completed

PIN: DELS-BEST-14-05

Project Duration (months): 18 month(s)

RSO: Wassel, Ray

Topic(s):

Environment and Environmental Studies
Health and Medicine
Policy for Science and Technology



Geographic Focus:

Committee Membership

Committee Post Date: 03/06/2015

Robert A. Hiatt - (Chair)
University of California, San Francisco

Robert A. Hiatt is professor and chair of the Department of Epidemiology and Biostatistics at the University of California, San Francisco (UCSF). He also is the associate director of the UCSF Helen Diller Family Comprehensive Cancer Center. In addition, Dr. Hiatt holds adjunct appointments as professor in the Division of Epidemiology at the University of California, Berkeley School of Public Health and as an adjunct investigator at the Division of Research at Kaiser Permanente Northern California in Oakland. From 1998 to early 2003, he was the first deputy director of the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI), where he oversaw cancer research in epidemiology and genetics, surveillance, and health services research. Dr. Hiatt has been the principal investigator of the Bay Area Breast Cancer and the Environment Research Center that is studying the influence of environmental factors on pubertal maturation as a window to understanding the causes of breast cancer. He is a past president of the American College of Epidemiology and the American Society for Preventive Oncology. He has served on several past Institute of Medicine (IOM) committees including the Committee on Breast Cancer and the Environment: The Scientific Evidence, Research Methodology, and Future Directions. Currently, Dr. Hiatt serves as a member of the IOM Committee on the State of the Science in Ovarian Cancer Research and the National Research Council’s Board on Environmental Studies and Toxicology. He received an M.D. from the University of Michigan and a Ph.D. in epidemiology from the University of California, Berkeley.
A. J. Bailer
Miami University

A. John Bailer is university distinguished professor and chair in the Department of Statistics, Scripps Research Fellow in the Scripps Gerontology Center, faculty affiliate of the Statistical Consulting Center, affiliate member of the Department of Zoology, and affiliate member of the Department of Sociology and Gerontology at Miami University in Oxford, Ohio. His research interests include the design and analysis of environmental and occupational health studies and quantitative risk estimation. Dr. Bailer is a fellow of the American Statistical Association (ASA), a fellow of the Society for Risk Analysis, and a recipient of the ASA Statistics and the Environment Distinguished Achievement Medal. He has served on several National Research Council committees, including the Committee on Improving Risk Analysis Approaches Used by the U.S. EPA, the Committee on Spacecraft Exposure Guidelines, the Committee to Review the OMB Risk Assessment Bulletin, and the Committee on Toxicologic Assessment of Low-Level Exposures to Chemical Warfare Agents. He also has served as a member of the Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee of the Board of Scientific Counselors of the National Toxicology Program. Dr. Bailer received a Ph.D. in biostatistics from the University of North Carolina at Chapel Hill.
Rebecca Bascom
The Pennsylvania State University

Rebecca Bascom is a professor of medicine at the Milton S. Hershey Medical Center at Pennsylvania State University. As a specialist in pulmonary medicine, her primary clinical focus is caring for patients with serious diseases of the lung. Dr. Bascom has conducted research on lung diseases and inhalation toxicology, including a team analysis to evaluate the cardiorespiratory health effects on New York City police officers exposed during the 9/11 terrorist attack. She is committed to multidisciplinary translational research, connecting basic scientists to her lung disease patients, and ensuring consistency with Penn State University research policies and procedures. She has enrolled patients with tobacco-related lung diseases in clinical trials for the past 10 years. Previously, she performed controlled human exposure studies using sidestream tobacco smoke and evaluated mechanisms of injury. She has served on several National Research Council committees, including the Committee on the Evaluation of the Department of Defense Comprehensive Clinical Evaluation Protocol, the Committee on Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, and the Committee on Health Effects of Indoor Allergens. In addition, Dr. Bascom served on the Institute of Medicine Committee on Scientific Standards for Studies on Modified Risk Tobacco Products. She trained in internal medicine, as well as pulmonary and critical care medicine at the Johns Hopkins Hospital. Dr. Bascom earned an M.D. from the University of Oregon Health Sciences Center and an M.P.H. in occupational medicine from the Johns Hopkins Bloomberg School of Public Health.
Larry R. Churchill
Vanderbilt University Medical Center

Larry R. Churchill (IOM) is the Ann Geddes Stahlman Professor of Medical Ethics at the Vanderbilt University Medical Center. Prior to Vanderbilt, Dr. Churchill was at the University of North Carolina at Chapel Hill, where he served as department chair of social medicine. His recent research has turned from policy questions and “big-decision” ethics to the moral dimensions of routine clinical encounters. Dr. Churchill served as a member of the Institute of Medicine (IOM) Committee on the Use of Complementary and Alternative Medicine by the American Public. He received a Ph.D. in religion from Duke University. Dr. Churchill was elected to the IOM in 1991.
Kenny S. Crump
Independent Consultant

Kenny S. Crump is an independent consultant. Previously, he was a principal with Environ Corporation. He has over 35 years of experience in assessing risks related to exposure to toxic materials. He has served on science advisory boards of the Environmental Protection Agency, the National Center for Toxicological Research, the Mickey Leland National Urban Air Toxics Research Center, and the National Institute of Environmental Health Sciences. His research interests are in the areas of biostatistics, health risk assessment, and analysis of epidemiological data. Statistical models for assessing risk developed by Dr. Crump have been widely used by regulatory agencies and private groups. These include the Linearized Multistage Model and the benchmark methodology. Dr. Crump has participated in risk assessments of many substances, including asbestos, benzene, manganese, and mercury. He was previously a member of the National Research Council’s Diesel Impacts Study Committee, the Committee on Risk Analysis Issues and Reviews, the Committee on Risk Assessment Methodology, and the Committee on Institutional Means for Assessment of Risks to Public Health. He recently served on the Institute of Medicine’s Committee to Evaluate Potential Exposure to Agent Orange/TCDD Residue and Level of Risk of Adverse Health Effects for Aircrew of Post-Vietnam C-123 Aircraft. Dr. Crump received a Ph.D. in mathematics from Montana State University.
Margaret Foster Riley
University of Virginia

Margaret Foster Riley is a professor of law in the School of Law, professor of public health sciences in the School of Medicine, and professor of public policy in the Batten School of Leadership and Public Policy at the University of Virginia. Her research focuses on human subjects research law and ethics, biotechnology, health care regulation, and food and drug law. She serves as chair of the university’s Embryonic Stem Cell Research Oversight Committee and as legal advisor to the Health Sciences Institutional Review Board, and is a member of the executive committee of the Center for Health Policy. Prior to joining the University of Virginia, Ms. Riley was an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial, and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. She served on the National Research Council’s Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, and has advised numerous committees of the Institute of Medicine and the Virginia Bar. Ms. Riley received a J.D. from Columbia University.
Daniela B. Friedman
University of South Carolina

Daniela B. Friedman is an associate professor in the Department of Health Promotion, Education, and Behavior at the Arnold School of Public Health of the University of South Carolina. She is also a core faculty member of the university’s Statewide Cancer Prevention and Control Program. Dr. Friedman uses both qualitative and quantitative methods to evaluate how people access, understand, and use information on disease risk and prevention. Her research examines individual and social influences on health comprehension, and she studies a variety of innovative strategies for the development and delivery of accurate, language-appropriate, and culturally sensitive health information. She received a Ph.D. in health studies and gerontology from the University of Waterloo in Canada.
Diane R. Gold
Harvard School of Public Health

Diane R. Gold is a professor in the Department of Environmental Health in the School of Public Health at Harvard University, professor of medicine at Harvard Medical School, and associate physician at Brigham and Women’s Hospital. Dr. Gold’s research focuses on the relationships between environmental exposures and the incidence or severity of respiratory diseases, including asthma. The environmental exposures considered include indoor allergens, such as fungi, smoking, and outdoor ozone and particles. She investigates the environmental exposures that may explain socioeconomic, cultural, and gender differences which have been observed in asthma severity. These include perinatal exposures and family stress as well as exposure to the allergens and pollutants mentioned above. She is also interested in the cardiopulmonary effects of particles on the elderly and she has collaborated in research involving controlled human exposures. Dr. Gold served on the Institute of Medicine’s Committee on an Assessment of Asthma and Indoor Air Quality. She received an M.D. from the University of Connecticut School of Medicine.
Lewis R. Goldfrank
New York University Langone Medical Center

Lewis R. Goldfrank (IOM) is chair and Herbert W. Adams Professor of the Department of Emergency Medicine at New York University, and medical director of the New York City Health Department’s Poison Center. Dr. Goldfrank has worked at the Bellevue Hospital Center and New York University’s Medical Center for more than thirty years. He has served on multiple Institute of Medicine (IOM) committees, including the Committee on Personal Protective Equipment for Healthcare Workers in the Workplace Against Novel H1N1 Influenza A. He currently serves as a member of the IOM’s Board on Health Sciences Policy and IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events. He received an M.D. from the University of Brussels Medical School. He was elected to the IOM in 1996.
Nancy E. Lane
University of California, Davis Health System

Nancy E. Lane (IOM) is an Endowed Professor of Medicine and Rheumatology at the University of California at Davis. She is also director of the Center for Musculoskeletal Health and Aging Research and director of the K12 NIH Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) program. She is principal investigator of the NIH funded Program on Sex Differences in Musculoskeletal Diseases Across the Lifespan at the University of California at Davis School of Medicine. Dr. Lane was president of the board of the United States Bone and Joint Decade and she co-led the International Bone and Joint Decade Conference in Washington, DC. She received an M.D. from the University of California at San Francisco School of Medicine. Dr. Lane was elected to the IOM in 2013.
Morton Lippmann
New York University School of Medicine

Morton Lippmann is a research professor in the Department of Environmental Medicine at New York University’s School of Medicine. Dr. Lippmann’s research has involved a series of studies that seek to identify the physical and chemical components of airborne particles responsible for observed health effects, including subchronic exposures to concentrated fine particles in a mouse model of atherosclerosis, and observational studies of human populations for association of acute and cumulative responses to exposures in the general atmospheric environment. Dr. Lippmann has served on several National Research Council committees, including the Committee on Air Quality in Passenger Cabins of Commercial Aircraft, the Committee on Toxicology, and the Committee on Research and Peer Review in EPA. He received a Ph.D. in environmental health science from New York University.
Murray A. Mittleman
Harvard University

Murray A. Mittleman is an associate professor in the Department of Epidemiology at the Harvard School of Public Health and an associate professor of medicine at the Harvard Medical School. He is the director of the Cardiovascular Epidemiology Research Unit at the Beth Israel Deaconess Medical Center; vice-chair of the Committee on Clinical Investigations, which serves as the Institutional Review Board, at the Beth Israel Deaconess Medical Center; and chair of the Master of Public Health program at the Harvard School of Public Health. Dr. Mittleman’s applied research focuses on behavioral and environmental determinants of acute cardiovascular events and their prognosis. He received an M.D. from McGill University and an M.P.H. and Dr.P.H. in epidemiology from the School of Public Health at Harvard University.
Philip Needleman
Washington University School of Medicine

Philip Needleman (NAS/IOM) was elected to the National Academy of Sciences in1987 and to the Institute of Medicine in 1993. He was a professor and chair of the Department of Pharmacology at Washington University Medical School (1976-1989) and chief scientist and head of R&D for Monsanto/Searle/Pharmacia (1989-2003). He was interim president of the Donald Danforth Plant Science Center (2009-10) and interim president and CEO of the St Louis Science Center (2010-11). He has served on the NAS council, chaired NAS Section 23, and served on the National Research Council’s Division of Earth and Life Studies. Dr. Needleman received a Ph.D. in pharmacology from the University of Maryland at College Park.
Robert F. Phalen
University of California, Irvine

Robert F. Phalen is co-director of the Air Pollution Health Effects Laboratory, professor in the Department of Medicine, and professor in the Center for Occupational and Environmental Health at the University of California, Irvine (UCI) School of Medicine. In 1972, Dr. Phalen joined the College of Medicine at UCI to establish the Air Pollution Health Effects Laboratory, which conducts studies relating to the toxicology of air pollutants. His research areas include lung modeling for predicting doses from inhaled particles, lung morphometry for growing mammals, health effects of inhaled air pollutants, and applied aerosol physics. He chaired the institutional review board (IRB) at UCI for seven years. He served on the National Research Council’s Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents. Dr. Phalen received a Ph.D. in biophysics, with specialization in inhalation toxicology, from the University of Rochester.
Hwashin H. Shin
Health Canada

Hwashin H. Shin is a Research Scientist in the Environmental Health Science and Research Bureau of Health Canada. She is also an adjunct professor in the Department of Mathematics and Statistics of Queen’s University in Ontario, Canada. Previously, she was a research associate at the Institute of Population Health at the University of Ottawa. Her research areas include environmental public health risk models, epidemiology, and experimental optimal design. Dr. Shin’s recent research topics include bias correction in estimation of public health risk attributable to short-term air pollution exposure, and the systematic review and meta-analysis of outdoor fine particles and strokes. Dr. Shin is a member of the Outdoor Air Pollution Committee of Global Burden Disease. She received a Ph.D. in statistics from Queen’s University.

Events



Location:

Teleconference
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
The meeting was held entirely in closed 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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Larry Churchill
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Nancy Lane
Morton Lippmann
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

Input received during public session held on August 24th
Recently received written materials
Development of committee's draft report

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

Meeting agenda
Draft report chapters

Date of posting of Closed Session Summary:
September 18, 2016
Publication(s) resulting from the event:

-


Location:

webinar
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
Information-Gathering Session via Webinar
August 24, 2016

PRELIMINARY AGENDA


OPEN SESSION: Wednesday, August 24th
(Contact Orin Luke at oluke@nas.edu to obtain instructions for joining the session.)

1:00 (EDT) Opening Remarks from Robert Hiatt (Committee Chair) and
Introduction of Committee Members

1:10 Presentation from Steve Milloy, JD
Publisher, JunkScience.com

1:40 Presentation from John Dunn, MD, JD
Civilian Faculty Emergency Medicine
Carl R. Darnall Army Medical Center

2:10 Presentation from Stanley Young, PhD
Fellow, American Statistical Association and the
American Association for the Advancement of Science

2:40 Committee Discussion with Presenters

3:40 Public comment
(Persons wanting to make a comment during this period can sign up in advance by sending an email to oluke@nas.edu. To submit written materials, contact Raymond Wassel at rwassel@nas.edu.)

4:10 End of open session



Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-


Location:

conference call
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
The meeting was held entirely in closed 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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Larry Churchill
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Lewis Goldfrank
Morton Lippmann
Murray Mittleman
Philip Needleman
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

Development of the committee's report

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

Draft chapters of the committee's report.

Date of posting of Closed Session Summary:
April 19, 2016
Publication(s) resulting from the event:

-


Location:

Conference calls
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
The meeting was held entirely in closed 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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Larry Churchill
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Lewis Goldfrank
Nancy Lane
Morton Lippmann
Murray Mittleman
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

Development of the committee's draft report

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

Draft chapters for the committee's report

Date of posting of Closed Session Summary:
March 14, 2016
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
The meeting was held entirely in closed 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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Larry Churchill
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Lewis Goldfrank
Nancy Lane
Morton Lippmann
Murray Mittleman
Philip Needleman
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

1. Written background information provided by EPA;
2. Draft text for the committee's report; and
3. Assignments for committee members and staff.


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

1. Recent written background information from EPA; and
2. Draft chapters of the committee's report.

Date of posting of Closed Session Summary:
December 23, 2015
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:  Orin Luke
Contact Email:  oluke@nas.edu
Contact Phone:  -

Agenda
The meeting was held entirely in closed 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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Nancy Lane
Morton Lippmann
Murray Mittleman
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

1. Controlled-human exposure studies conducted by EPA.

2. Use of controlled-human exposure study results in EPA's integrated science assessments for ozone and particulate matter national ambient air quality standards.

3. Methods for estimating risks to study participants.

4. Foreseeable risks to study participants and risk communication.

5. Development of the committee's report.

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

Draft written documents prepared by committee members.

Date of posting of Closed Session Summary:
September 14, 2015
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:  Orin Luke
Contact Email:  OLuke@nas.edu
Contact Phone:  -

Agenda
NAS Building, Room 125

June 1, 2015 Open Session

12:45 Registration for Open Session

1:00 Opening Remarks from Committee Chair Robert Hiatt and Introduction of Committee Members

1:15 EPA Research Overview
Robert Kavlock (Deputy Assistant Administrator for Science, EPA/ORD)

1:30 Foundations of the NAS Charge: Ethical Issues in Foreseeable Risk
Toby Schonfeld (Director, EPA Program in Human Research Ethics and Oversight; EPA Human Subjects Research Review Official)

2:15 Break

2:30 Conduct, Process, and Outcomes of Exposure Studies,
Wayne Cascio (Director, Environmental Public Health Division, National Health Environmental Effects Research Laboratory, EPA/ORD)
David Diaz-Sanchez (Chief, Clinical Research Branch, National Health Environmental Effects Research Laboratory, EPA/ORD)

3:15 EPA Human Subjects Regulatory Requirements
Dan Nelson (Director, Human Research Protocol Office, National Health Environmental Effects Research Laboratory, EPA/ORD)

3:35 Summary and Wrap-Up
Toby Schonfeld

3:45 Committee Discussion with Presenters

4:30 Open Mic
(Each speaker has a maximum time limit of 5 minutes. Accompanying written materials are encouraged.)

5:00 End of Open Session


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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:

Robert Hiatt (Chair)
A. John Bailer
Rebecca Bascom
Larry Churchill
Kenny Crump
Margaret Foster Riley
Daniela Friedman
Diane Gold
Lewis Goldfrank
Nancy Lane
Morton Lippmann
Murray Mittleman
Philip Needleman
Robert Phalen
Hwashin Shin


The following topics were discussed in the closed sessions:

1. Committee's statement of task
2. Committee's general approach to carrying out its study
3. Open session presentations and written materials from EPA representatives
4. Plans for future meetings
5. Assignments for committee members and project staff

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

1. Printed versions of the visual aids used for EPA presentations in open session.
2. IRB applications and consent forms presented to potential participants for EPA controlled human exposure studies.
3. Relevant materials presented in National Ambient Air Quality Standards (NAAQS) Integrated Science Assessments (ISAs)
4. List of publications of possible relevance to the committee's study
5. EPA Follow Up to OIG Report No. 14-P-0154

Date of posting of Closed Session Summary:
June 03, 2015
Publication(s) resulting from the event:

-

Publications

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