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Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies Workshop Summary Food Forum Food and Nutrition Board Institute of Medicine National Academy Press Washington, D.C. 1999
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National Academy Press 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and on its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. This project was funded by the U.S. Department of Health and Human Services Food and Drug Administration, U.S Department of Agriculture Food Safety and Inspection Service, U.S. Department of Commerce National Marine Fisheries Service, U.S. Environmental Protection Agency, Frito-Lay, Inc.; Hershey Foods; Kellogg Company; Kraft Foods, Inc.; McDonald's Corporation, Monsanto Company; Nabisco, Inc.; Nestlé USA; Proctor & Gamble; and Ross Products. The opinions expressed herein are those of the workshop participants and do not necessarily reflect those of the funders. International Standard Book No. 0-309-06486-4 Library of Congress Catalog Card Number 99-62305 Additional copies of Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies: Workshop Summary are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area) or visit the NAP's on-line bookstore at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www2.nas.edu/iom. Copyright 1999 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.
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Food Forum FERGUS M. CLYDESDALE (Chair), University Of Massachusetts, Amherst PERRY L. ADKISSON, Texas A&M University, College Station DIANE FEICKERT BIRT, Iowa State University, Ames MARSHA N. COHEN, Hastings College Of The Law, University Of California, San Francisco JOHN M. CONNOR, Purdue University, West Lafayette, Indiana MICHAEL P. DOYLE, University Of Georgia, Griffin ROBERT DROTMAN, Frito-Lay, Inc., Plano, Texas CHARLES DUNCAN, Hershey Foods, Hershey, Pennsylvania VICTOR FULGONI, Kellogg Company, Battle Creek, Michigan MICHAEL J. GOLDBLATT, Mcdonald's Corporation, Oak Brook, Illinois EDWARD GROTH III, Consumers Union, Yonkers, New York RICHARD L. HALL, Consultant, Baltimore, Maryland ARTHUR L. HECKER, Ross Products Division, Abbott Laboratories, Columbus, Ohio JERRY HJELLE, Monsanto Company, Deerfield, Illinois WILLIAM KELLY JONES, Nabisco Foods Group, East Hanover, New Jersey EILEEN MADDEN, Nestlé Usa, Inc., Purchase, New York RICHARD A. MERRILL, University Of Virginia School Of Law, Charlottesville SANFORD A. MILLER, Graduate School Of Biomedical Sciences, University Of Texas Health Science Center, San Antonio M. JAYE NAGLE, Kraft Foods, Glenview, Illinois MICHAEL W. PARIZA, University Of Wisconsin, Madison KEITH TRIEBWASSER, Procter & Gamble, Cincinnati, Ohio Ex-Officio Members E. SPENCER GARRETT, National Marine Fisheries Service, Pascagoula, Mississippi LYNN GOLDMAN, U.S. Environmental Protection Agency, Washington, DC DAVID A. KESSLER, Food And Drug Administration, Rockville, Maryland DAVID R. LINEBACK, University Of Idaho, Moscow GEORGE PATERSON, Health Canada, Ottawa, Ontario DONNA V. PORTER, Library Of Congress, Washington, DC MICHAEL TAYLOR, United States Department Of Agriculture, Washington, DC Forum Staff SANDRA SCHLICKER, Director KATHERINE J. GORTON, Policy Intern GERALDINE KENNEDO, Project Assistant
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Food And Nutrition Board CUTBERTO GARZA (Chair), Division of Nutrition, Cornell University, Ithaca, New York JOHN W. ERDMAN, JR. (Vice Chair), Division of Nutritional Sciences, College of Agriculture, University of Illinois at Urbana-Champaign BENJAMIN CABALLERO, Center for Human Nutrition, The Johns Hopkins School of Hygiene and Public Health, Baltimore, Maryland FERGUS M. CLYDESDALE, Department of Food Science, University of Massachusetts, Amherst ROBERT J. COUSINS, Center for Nutritional Sciences, University of Florida, Gainesville JOHANNA T. DWYER, Frances Stern Nutrition Center, New England Medical Center Hospital and Departments of Medicine and Community Health, Tufts Medical School and School of Nutrition Science and Policy, Boston, Massachusetts SCOTT M. GRUNDY, Center for Human Nutrition, University of Texas Southwestern Medical Center at Dallas CHARLES H. HENNEKENS, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts ROSS L. PRENTICE, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington A. CATHARINE ROSS, Department of Nutrition, Pennsylvania State University, University Park ROBERT E. SMITH, R. E. Smith Consulting, Inc., Newport, Vermont VIRGINIA A. STALLINGS, Division of Gastroenterology and Nutrition, The Children's Hospital of Philadelphia, Pennsylvania Ex-Officio Member STEVE L. TAYLOR, Department of Food Science and Technology and Food Processing Center, University of Nebraska, Lincoln Staff ALLISON A. YATES, Director GAIL E. SPEARS, Administrative Assistant
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PREFACE The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop. The workshop began with Professor Noah's overview of the Food Additives Amendment Act of 1958 and how the U.S. Food and Drug Administration (FDA), over the period of the law's existence, has interpreted and applied the law. This overview was followed by a panel of reactors who spoke about their expectations and perceptions of the congressional and administrative decisions. Members of this panel were lawyers with experience in the legal aspects of the food ingredient approval process and represented consumers, industry, and government. The afternoon session began with an overview of the changes in science and technology and related policy factors that have impacted the FDA's decision-making since the passage of the Food Additives Amendment Act of 1958. Generic lessons learned from experience and case studies about direct food additives were presented. Individuals from government, industry, and consumer groups reacted to the lessons learned from the case studies. An open discussion among speakers and the audience ended the first day's program.
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The second day of the workshop focused on the opportunities for reform of the current food ingredient approval system. Speakers from the FDA, industry, Congress, and consumer groups presented their views on the causes of the problems and possible remedies. Open discussion among all participants followed this panel. An agenda and list of participants can be found at the end of the workshop summary. The purpose of a Forum at the IOM is to foster dialogue and discussion across sectors and institutions. Public forums offer a mechanism for convening individuals from a variety of government, academic, industry, and citizen groups and provide a structured opportunity for open communication among representatives of these groups. The objective, however, is to illuminate issues, not to resolve them. Unlike study committees of the IOM, Forums cannot provide advice or recommendations to any government agency or other organization. Similarly, workshop summaries or other products resulting from forum activities are not intended to reach conclusions or recommendations but, instead, are to reflect the variety of opinions expressed by the participants. The comments in this report represent the views of the workshop participants, as indicated generically in the text. The identification of a speaker as an "industry representative" or a "FDA representative" is not intended to suggest that the individual speaks for that organization or others who work there. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The content of the final report is the responsibility of the Institute of Medicine and the study committee and not the responsibility of the reviewers. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The forum wishes to thank the following individuals, who are neither officials nor employees of the Institute of Medicine, for their participation in the review of this report: Caroline Smith DeWaal, J.D., Center for Science in the Public Interest; Peter Barton Hutt, LL.M., Covington & Burling; Franklin M. Lowe, D.V.M., Ph.D., Becker College; Judith Stern, Ph.D., University of California at Davis; and Donna U. Vogt, M.A., Congressional Research Service. While the individuals listed above have provided many constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the Institute of Medicine.
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CONTENTS Workshop Summary 1 Appendixes A Legal Aspects of the Food Additive Approval Process 13 B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug, and Cosmetic Act of 1938 107 Technological and Social Factors that Have Affected Introduction of New Direct Food Ingredients and Processes 111 Cyclamate 117 Irradiated Poultry 120 Olestra 123 FD&C Red No. 2 (Amaranth) 125 FD&C Red No. 3 (Erythrosine) 127 TCE and DCM 129 d-Limonene 132 Benzyl Acetate 133 iso-Amyl Acetate 135 Furfural 136 Pulsed Light 138 Chymosin 139 C Workshop Agenda 141 D Participant List 143 Acronyms 149
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