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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
THE DEVELOPMENT OF DRIS 1994–2004
Lessons Learned and New Challenges
Workshop Summary
Marla Sheffer and Christine Lewis Taylor, Rapporteurs
Food and Nutrition Board
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
THE NATIONAL ACADEMIES PRESS
500 Fifth Street, N.W. Washington, DC 20001
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.
This study was supported by Contract No. HHSP2332004509XI TO #8 between the National Academy of Sciences and U.S. Department of Health and Human Services; Contract No. AG-0202-P-06-0014 between the National Academy of Sciences and U.S. Department of Agriculture; and Contract No. 4500164550 between the National Academy of Sciences and Health Canada. Additional support came from the Canadian Institutes of Health Research. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
International Standard Book Number-13: 978-0-309-11562-9
International Standard Book Number-10: 0-309-11562-0
Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.
Copyright 2008 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.
Suggested citation: Institute of Medicine (IOM). 2008. The development of DRIs 1994–2004: Lessons learned and new challenges—workshop summary. Washington, DC: The National Academies Press.
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
www.national-academies.org
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
PLANNING COMMITTEE FOR DIETARY REFERENCE INTAKES REVIEW WORKSHOP
JOHN W. SUTTIE (Chair),
Department of Biochemistry, University of Wisconsin, Madison
STEPHANIE A. ATKINSON,
Nutrition and Metabolism Research Laboratory, Department of Pediatrics, McMaster University, Hamilton, Ontario
JANET C. KING,
University of California at Berkeley and Davis, Children’s Hospital Oakland Research Institute, Oakland
SUSAN TAYLOR MAYNE,
Division of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT
HUGUETTE TURGEON O’BRIEN,
Department of Food Sciences and Nutrition, Laval University, Quebec City, Quebec
WILLIAM M. RAND,
Department of Public Health and Family Medicine, Tufts University School of Medicine, Boston, MA
ROBERT M. RUSSELL,
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA
Staff
CHRISTINE LEWIS TAYLOR, Study Director and Scholar
HEATHER DEL VALLE, Research Associate
SANDRA AMAMOO-KAKRA, Program Associate
MARLA SHEFFER, Consultant Writer,
Orleans, Ontario
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
FOOD AND NUTRITION BOARD*
DENNIS M. BIER (Chair),
Children’s Nutrition Research Center, Baylor College of Medicine, Houston, TX
MICHAEL P. DOYLE (Vice Chair),
Center for Food Safety, University of Georgia, Griffin
DIANE BIRT,
Center for Research on Dietary Botanical Supplements, Iowa State University, Ames
YVONNE BRONNER,
School of Public Health and Policy, Morgan State University, Baltimore, MD
FERGUS M. CLYDESDALE,
Department of Food Science, University of Massachusetts, Amherst
GORDON L. JENSEN,
Department of Nutritional Sciences, Pennsylvania State University, University Park
REYNALDO MARTORELL,
Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA
SUSAN TAYLOR MAYNE,
Division of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT
SANFORD A. MILLER,
Center for Food, Nutrition, and Agriculture Policy, University of Maryland, College Park
J. GLENN MORRIS, JR.,
Emerging Pathogens Institute, University of Florida, Gainesville
SUZANNE P. MURPHY,
Cancer Research Center of Hawaii, University of Hawaii, Honolulu
JOSE M. ORDOVAS,
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA
MARTIN A. PHILBERT,
School of Public Health, University of Michigan, Ann Arbor
JIM E. RIVIERE,
College of Veterinary Medicine, North Carolina State University, Raleigh
REBECCA J. STOLTZFUS,
Division of Nutritional Sciences, Cornell University, Ithaca, NY
PATRICK J. STOVER,
Institute for Nutritional Genomics, Division of Nutritional Sciences, Cornell University, Ithaca, NY
WALTER C. WILLETT,
Department of Nutrition, Harvard School of Public Health, Boston, MA
Staff
LINDA D. MEYERS, Director
GERALDINE KENNEDO, Administrative Assistant
ANTON L. BANDY, Financial Officer
*
IOM boards do not review or approve individual reports and are not asked to endorse conclusions and recommendations. The responsibility for the content of the summary rests with the rapporteurs and the institution.
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
Reviewers
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 institution in making its 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 review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Frances Seligson, Hershey, PA
John W. Suttie, Department of Biochemistry, University of Wisconsin
John E. Vanderveen, Food and Drug Administration, Rockville, MD
Susan Whiting, College of Pharmacy and Nutrition, University of Saskatchewan, Canada
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Hugh Tilson, M.D., Dr.P.H., M.P.H., University of North Carolina, who was appointed by the Institute of Medicine. He was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the author and the institution.
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
Contents
ACRONYMS
xiii
PREFACE
xv
1
WORKSHOP INTRODUCTION
1
Welcome and Opening Remarks,
John Suttie
1
Overview of Current DRI Framework and Issues Raised,
Christine Taylor
3
2
CONCEPTUAL FRAMEWORK FOR DRI DEVELOPMENT: SESSION 1
11
Current Framework for DRI Development: What Are the Pros and Cons?,
Robert M. Russell
13
Case Study: Applying the DRI Framework to Chronic Disease Endpoints,
Paula Trumbo
19
Case Study: Applying the DRI Framework to Non-Chronic Disease Endpoints,
Allison Yates
25
Discussion: Framework Pros/Cons; Case Studies,
Patsy Brannon and Alice H. Lichtenstein
29
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Two Perspectives: The DRI Framework,
32
Perspective I,
George Beaton
32
Perspective II,
Janet King
37
Evaluating Evidence for DRI Development: What Are the Issues in Applying Systematic Evidence-Based Review Approaches to DRI Development?,
Alice H. Lichtenstein
40
Risk Assessment: Is It a Relevant Organizing Structure?,
Elizabeth A. Yetley
46
Discussion: Systematic Evidence-Based Review; Risk Assessment,
Sanford Miller
54
Panel Discussion: In What Ways Could the Conceptual Framework Be Enhanced?,
Cutberto Garza, Mary L’Abbé, Irwin Rosenberg, and Barbara Stoecker
56
3
CRITERIA FOR SCIENTIFIC DECISION MAKING: SESSION 2
63
Selecting Endpoints: What Are the Issues and What Are the Options for Criteria?,
Irwin Rosenberg
64
Dose–Response Data: Are There Options for Dealing with Limited Data?,
Susan Taylor Mayne
68
What Are the Challenges in Addressing Extrapolation/ Interpolation for Unstudied Groups?,
Stephanie A. Atkinson
77
What Are the Challenges in Addressing Adjustment for Data Uncertainty?,
Hildegard Przyrembel
81
Estimating Dietary Intake: What Are the Implications for DRI Development?,
Amy Subar
87
Highlights of Other Important Issues: Physiological, Environmental, and Genomic Factors,
Cutberto Garza
93
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
4
GENERAL GUIDANCE FOR USERS OF DRIs: SESSION 3
99
Overview: Issues Raised About General Guidance for Users,
Christine Taylor
100
Discussion,
Johanna Dwyer
102
Special Challenges: Planning and Assessing the Total Diet—What Are the Issues and What Are the Options for Enhanced Guidance?,
104
Assessing the Total Diet,
Suzanne Murphy
105
Planning the Total Diet,
Susan Barr
107
Discussion,
Patricia Guenther and Krista Esslinger
110
Special Challenges: What Are the Issues Related to a Framework for Individual-Level and Group-Level Applications?,
Valerie Tarasuk
114
Discussion,
Gerard Dallal
117
Panel Discussion: In What Ways Could the Guidance for Users of DRIs Be Enhanced?,
Danielle Brulé, Mary Frances Picciano, William Rand, and Linda Van Horn
119
5
LOOKING TO THE FUTURE PROCESS FOR DRI DEVELOPMENT: SESSION 4
123
Emerging Issues: What New Challenges Might the Future Hold?,
Catherine Woteki
124
Is There a Need to Enhance Transparency of the Decision-Making Process?,
Robert M. Russell
128
Opportunities for Stakeholder Input in IOM Activities,
Linda D. Meyers
133
What Are the Criteria Options for Determining When to Update/Review Existing DRIs?,
John Suttie
136
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
What Are the Considerations in Specifying “New” Nutrient Substances for DRI Study?,
Peter Greenwald
138
Panel Discussion: Reflections on What We Have Heard About the Process of DRI Development,
Mary Bush, Jean-Pierre Habicht, Suzanne Harris, Van Hubbard, and Molly Kretsch
145
6
SUMMARY AND CLOSING REMARKS
John Suttie Paul Coates
151
REFERENCES
155
APPENDIXES
A
Workshop Agenda and Background Materials
161
B
Workshop Presenters, Discussants, Panelists, and U.S./Canadian Sponsor Representatives
169
C
Brief List of Reoccurring Workshop Discussions
175
D
Schematic Used by Workshop Planning Committee: Activities Associated with DRI Development
179
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
Acronyms
AI Adequate Intake
ALA α-linolenic acid
AMDR Acceptable Macronutrient Distribution Range
AROI Acceptable Range of Oral Intake
ATBC Alpha-Tocopherol Beta-Carotene
BMI body mass index
BMR basal metabolic rate
BW body weight
CDC Centers for Disease Control and Prevention
CHD coronary heart disease
CV coefficient of variation
CVD cardiovascular disease
DHA docosahexaenoic acid
DNA deoxyribonucleic acid
DRI Dietary Reference Intake
EAR Estimated Average Requirement
EC European Commission
EER Estimated Energy Requirement
EFSA European Food Safety Authority
EPA eicosapentaenoic acid
EU European Union
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FACA Federal Advisory Committee Act
FDA U.S. Food and Drug Administration
FFQ food frequency questionnaire
FNB Food and Nutrition Board
IOM Institute of Medicine
ISU Iowa State University
LDL low-density lipoprotein
LOAEL lowest-observed-adverse-effect level
NAS National Academy of Sciences
NCI National Cancer Institute
NHANES National Health and Nutrition Examination Survey
NIH National Institutes of Health
NOAEL no-observed-adverse-effect level
NRC National Research Council
OPEN Observing Protein and Energy Nutrition
PICO population, intervention, comparator, outcome
RAE retinol activity equivalent
RDA Recommended Dietary Allowance
RNI Recommended Nutrient Intake
SD standard deviation
SEBR systematic evidence-based review (also abbreviated in some documents as SR)
TSH thyroid stimulating hormone
UF uncertainty factor
UK United Kingdom
UL tolerable upper intake level
USDA U.S. Department of Agriculture
WHO World Health Organization
WIC Special Supplemental Nutrition Program for Women, Infants and Children
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The Development of DRIs 1994–2004: Lessons Learned and New Challenges - Workshop Summary
Preface
In what ways can the process for developing Dietary Reference Intakes (DRIs) be enhanced? The workshop entitled “The Development of DRIs 1994–2004: Lessons Learned and New Challenges” offered a valuable window into the issues and challenges inherent in the development of nutrient reference values. The dialogue—carried out under the auspices of the Institute of Medicine (IOM), Food and Nutrition Board (hereafter referred to jointly as the IOM)—was enriched by the 10 years of experience in deriving the expanded set of values known as the DRIs, plus the decades of experience that grounded the earlier Recommended Dietary Allowances for the United States and the Recommended Nutrient Intakes for Canada. The lessons learned and the knowledge gained will guide decisions about the next phase of the DRIs. To paraphrase one participant, we are now asking better questions.
In 2006, the IOM, with support from the United States and Canadian governments, undertook an effort to synthesize the research needs identified during the 10 years of DRI development. While the workshop summarized here was predicated on the fact that the development of DRIs is improved by better data, its focus was different. Its goals were to examine the framework1 and conceptual underpinnings for developing DRIs and to identify issues important for enhancing the process of DRI development.
1
Agreement is lacking as to whether the preferred or appropriate term is “framework,” “approach,” “model,” or “paradigm.” The term generally used in this summary is “framework.” However, given the lack of consensus, no efforts were made to change speakers’ or discussants’ remarks to universally refer to a single term.
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The United States and Canadian governments again served as sponsors for this important effort.
The process for developing nutrient reference values in the United States and Canada has evolved over time. For example, the earliest editions undertaken by the National Research Council, dating back to the 1940s and 1950s, included fewer nutrients and less background than did later editions. Beginning in 1994, efforts overseen by the IOM resulted in DRIs that specified several kinds of reference values and provided more volumes of accompanying explanation as well as guidance for users. These changes, of course, were a function of the increasing knowledge base in the field of nutrient requirements as well as evidence of the consequences of excessive intake. However, they were also due to the increasing interest in providing transparency for the decision-making process and in communicating better with those responsible for making the public health policy that depends on the reference values.
The workshop was designed to use the existing framework for DRI development as a basis for the discussions and to consider the components of the framework in sequence. Consideration of the pros and cons of the current conceptual underpinnings of the framework opened the workshop, followed by the general “road map” for decision making and the needed scientific criteria. Next, the challenges associated with providing guidance for users were explored. The workshop concluded with an array of issues germane to the future process for developing DRIs, including strategies for updating and revising existing DRIs and opportunities for stakeholder input.
Many topics were interrelated and common themes often emerged during different discussions. Transparency and the need for more information on the rationale behind the decisions made were important themes sounded during the workshop. There was also interest in determining a method whereby the uncertainty surrounding the reference values could be better articulated and made known to users. In looking to the future, the advantages of focusing on single nutrients or groups of similar nutrients were highlighted. Appendix C of this summary contains a brief listing of reoccurring workshop discussions and may be useful to readers.
Given the history that many participants brought with them to the workshop, it was not surprising that the discussions were rich and focused. Nor was it surprising that the numerous successes of the DRI process were readily acknowledged. What was remarkable and very gratifying was the willingness of those close to the DRI process to openly discuss newer options and to readily acknowledge the appropriateness of some changes.
Although many presenters, discussants, and panelists expressed viewpoints and recommended specific strategies, their perspectives and recommendations should not be viewed as workshop conclusions or rec-
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ommendations. The workshop was designed to identify issues and foster discussion, not to identify consensus recommendations. The discussions will be useful in planning the next stage of DRI activities, and clearly such planning activities will benefit greatly from the workshop conversations.
Christine Lewis Taylor, IOM Scholar and Study Director
Linda D. Meyers, Director, Food and Nutrition Board
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