National Academies Press: OpenBook

Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues (2004)

Chapter: Appendix F: Combined Registrants List for All Meetings

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Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Appendix F
Combined Registrants List for All Meetings

Stanley Abrahamson

Partner

Arent Fox Kintner Plotkin & Kahn, PLLC

John Adgate

Assistant Professor

School of Public Health

University of Minnesota

Diane Allemang

Director, Regulatory Affairs

Cheminova

Alan Ayers

Head-State Affairs/Stewardship

Bayer CropScience

Rhoda Barnat

Managing Director

Abernathy MacGregor

Craig Barrow

Dow Chemical

Nancy Beck

Toxicologist/Risk Assessor

Office of Information and Regulatory Affairs

Office of Management and Budget

Sharon Begley

Reporter

Wall Street Journal

Richard B. Belzer

President

Regulatory Checkbook

Karin Bentley

Global Regulatory Toxicologist

DuPont Crop Protection

Richard Bissell

Executive Director

Policy and Global Affairs Division

The National Academies

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Ann Bleacker

Head, Regulatory Toxicology

Bayer CropScience

Elizabeth Boa

Senior Manager

Regulatory/Technical Center for Expertise

American Chemistry Council

Daniel Botts

Director

Florida Fruit and Vegetable Association

Environmental and Pest Management Division

W. Stephen Brimijoin

Professor and Chair

Department of Molecular Pharmacology and Experimental Therapeutics

Mayo Clinic

Angus Cameron

BCG-Europe

Roslin BioCentre

Lisa Campbell

Bergeson & Campbell, P.C.

Arthur Caplan

Chair, Department of Medical Ethics

Director, Center for Bioethics

University of Pennsylvania

John Carley

U.S. Environmental Protection Agency

Wayne Carlson

Bayer CropScience

Neil Carmichael

Global Director of Toxicology

Bayer CropScience

Barry Castleman

Gail Charnley

Health Risk Strategies

Ian Chart

Vice President

Director of Regulatory Affairs

AMVAC Chemical Corporation

Ethel Chase

Peg Cherny

Bayer CropScience

Margaret Chu

Office of Research and Development

U.S. Environmental Protection Agency

David Clarke

American Chemistry Council

Greg Coffey

Bayer CropScience

James W. Conrad, Jr.

American Chemistry Council

Roger Cortesi

Senior Science Advisor

U.S. Environmental Protection Agency

Shelley Davis

Co-Executive Director

Farm Worker Justice Fund

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

John D. Doherty

U.S. Environmental Protection Agency

Larry Dorsey

U.S. Environmental Protection Agency

Michael L. Dourson

Director

Technology Excellence for Risk Assessment

Sidney Draggan

Senior Science and Science Policy Advisor

Office of Research and Development

U.S. Environmental Protection Agency

Angelina Duggan

Science Policy Director

Science and Regulatory

CropLife America

Monty Eberhart

Director, Product Safety Management

Product Safety Management

Bayer CropScience

Ernest Falke

U.S. Environmental Protection Agency

William Farland

Acting Deputy Assistant Administrator for Science

Office of Research and Development

U.S. Environmental Protection Agency

Daniel D. Federman

Senior Dean for Alumni Relations and Clinical Teaching

Carl W. Walter Distinguished Professor of Medicine and Medical Education

Harvard Medical School

Penny Fenner-Crisp

Executive Director

Risk Science Institute International Life Science Institute

Christina Geisert

Intern

Office of Pesticide Programs

U.S. Environmental Protection Agency

Pat Getter

CropLife America

Steven Gibb

Reporter

FDA Weekly

Lynn Goldman

Chairman of the Board, Children’s Environmental Health Network

Professor, Environmental Health Sciences

Johns Hopkins Bloomberg School of Public Health

Denise Grady

Reporter

The New York Times

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Linda E. Greer

Program Director

Health & the Environment

National Research Defense Council

Dawn Grodsky

Managing Editor

Clean Air Report

Inside EPA

Ephi Gur

Manager of Regulatory and Scientific Affairs

Makhteshim Agan of North America Inc.

Steven G. Gurney

Geologist

Health & the Environment Program

National Research Defense Council

Barry M. Hartman

Kirkpatrick & Lockhart, LLP

Andrew Hawkins

Reporter

Blue Sheet

John Heilprin

Reporter

Associate Press

Bette Hileman

Reporter

Chemical & Engineering News

Larry Hodges

Registration Manager

Regulatory Affairs

Bayer CropScience

David Hrdy

Biologist

Health Effect Division

Office of Pesticide Programs

Leslie J. Hushka

Scientific Associate

Business Support

ExxonMobil Biomedical Sciences, Inc.

Susan Ildstad

Director, Institute for Cellular Therapeutics

Professor of Surgery, Jewish Hospital

University of Louisville

Stephen Johnson

Assistant Administrator

Office of Prevention, Pesticides and Toxic Substances

U.S. Environmental Protection Agency

William Jordan

Senior Policy Adviser for Pesticides

Office of Pesticide Programs

U.S. Environmental Protection Agency

Jeffrey Kahn

Director and Professor

Center for Bioethics

University of Minnesota

Jocelyn Kaiser

Reporter

Science Magazine

Hannah Kamenetsky

Freelance Reporter

The Scientist

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Nancy Kass

Director

Program in Law, Ethics, and Health

Johns Hopkins University Bloomberg School of Public Health

William Kelly

Western Representative

Center for Regulatory Effectiveness

Jim Kling

Reporter

Web MD

David Kramer

Editor

Science and Government Report, Technical Insights

Frost and Sullivan

Steven Lamm

Consultants in Epidemiology and Occupational Health, Inc.

Philip J. Landrigan

Ethel H. Wise Professor of Community Medicine

Mt. Sinai School of Medicine

Patrick Linehen

Abernathy MacGregor

Alan Hebert Lockwood

Professor of Neurology, Nuclear Medicine

School of Medicine and Biomedical Sciences

State University of New York, Buffalo

Joan Lowry

Reporter

Scripps Howard News Service

Judith MacGregor

Toxicology Consulting Services

Susan Makris

Toxicologist

Office of Pesticide Programs

U.S. Environmental Protection Agency

Ann Manley

Director of Toxicology

AMVAC Chemical Corporation

Karen Martin

Group Leader, Health and Ecosystems Effects Group

Office of Air Quality Planning and Standards

U.S. Environmental Protection Agency

Ray McAllister

Vice President, Science and Regulatory Affairs

CropLife America

Ernest McConnell

President

ToxPath

Elizabeth Mendez

Toxicologist

Human Health Effects Division

U.S. Environmental Protection Agency

David E. Menotti

Shaw Pittman LLP

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Richard Merrill

Daniel Caplin Professor of Law

School of Law

University of Virginia

Michael Metzger

Chief, RRB1

Health Effects Division

U.S. Environmental Protection Agency

David Miller

Office of Pesticide Programs

U.S. Environmental Protection Agency

Deirdre Murphy

Emissions Standards Division

Office of Air Quality Planning & Standards

U.S. Environmental Protection Agency

Herber L. Needleman

Professor of Pediatrics

Member, Research Group on Lead

University of Pittsburgh Medical School

George Oliver

Science Policy Leader

Government and Public Affairs

Dow AgroSciences

Eric Olson

Senior Attorney

Natural Resources Defense Council

Jacqueline Patterson

Environmental Scientist

Toxicology Excellence for Risk Assessment

Pat Phibbs

Reporter

Daily Environment Report

BNA, Inc.

Mary Beth Polley

Assistant Editor

Pesticide and Toxic Chemical News

CRC Press LLC

Andrew Pope

Director, Health Science Policy Program

Institute of Medicince

The National Academies

Christopher Portier

Director

Environmental Toxicology Program

National Institute of Environmental Health Sciences

Peter Preuss

Director

National Center for Environmental Research

U.S. Environmental Protection Agency

Vivian Prunier

U.S. Environmental Protection Agency

Tony Reichhardt

Reporter

Nature

Jean Reimers

Bayer CropScience

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Bruce Rodan

Medical Officer (Research)

U.S. Environmental Protection Agency

Chad Sandusky

Senior Toxicologist

Physicians Committee for Responsible Medicine

Jennifer Sass

Senior Scientist

Natural Defense Resources Defense Council

Scott Schang

Associate

Environmental, Land, and Resources Department

Latham & Watkins

Rita Schoeny

Senior Science Advisor

Office of Water

U.S. Environmental Protection Agency

Rick Schwabacher

Washington Representative

The Cousteau Society

Mark Seaton

U.S. Environmental Protection Agency

Vera Hassner Sharav

President

Alliance for Human Research Protection

Virginia Ashby Sharpe

Project Director, Integrity in Science

Center for Science in the Public Interest

Karen Shearer

Bayer CropScience

Robert L. Sielken, Jr.

Sielken & Associates Consulting, Inc.

Burleson Smith

U.S. Department of Agriculture

Carol Stroebel

Health Policy Consultant

Children’s Environmental Health Network

Lauren E. Sucher

Environmental Working Group

Christina Swartz

Senior Scientist

Office of Pesticide Programs

U.S. Environmental Protection Agency

Abraham Tobia

Toxicology Fellow

Toxicology Department

Bayer CropScience

Dennis Utterback

Office of Science Policy

U.S. Environmental Protection Agency

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

Kenneth Weinstein

Partner

Environment, Land, and Resources Department

Latham and Watkins

Paul Whatling

Senior Product Manager

Cheminova, Inc.

Richard Wiles

Vice President for Research

Environmental Working Group

Chris F. Wilkinson

Principal

C. Wilkinson, LLC

Eric Wintemute

President

AMVAC Chemical Corporiation

Liesel Wolff

Congressional Liaison

People for the Ethical Treatment of Animals

Alison Young

Reporter

KR Washington

Susan Hunter Youngren

Bergeson & Campbell, PC

Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 201
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 202
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 203
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 204
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 205
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 206
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 207
Suggested Citation:"Appendix F: Combined Registrants List for All Meetings." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 208
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The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following:

  • The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can’t be answered with animal studies or nondosing human studies;
  • The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and
  • All recognized ethical standards and procedures for protecting the interests of study participants are observed.

In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies – both at the beginning and upon completion of the experiments – if they are carried out with the intent of affecting the agency's policy-making.

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