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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25023.
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GLOBAL HARMONIZATION OF METHODOLOGICAL APPROACHES TO NUTRIENT INTAKE RECOMMENDATIONS PROCEEDINGS OF A WORKSHOP Leslie Pray and Ann L. Yaktine, Rapporteurs Food and Nutrition Board Health and Medicine Division PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 This activity was supported by a contract between the National Academy of Sci- ences and the Bill and Melinda Gates Foundation (#10003263). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: International Standard Book Number-10: Digital Object Identifier: https://doi.org/10.17226/25023 Additional copies of this publication are available for sale from the National A ­ cademies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2018 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Global harmonization of methodological approaches to nutrient intake recommendations: Proceedings of a workshop. Washington, DC: The National A ­ cademies Press. doi: https://doi.org/10.17226/25023. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institu- tion to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the char- ter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and ad- vice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based con- sensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommen- dations based on information gathered by the committee and the com- mittee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

PLANNING COMMITTEE ON THE GLOBAL HARMONIZATION OF METHODOLOGICAL APPROACHES TO NUTRIENT INTAKE RECOMMENDATIONS1 STEPHANIE ATKINSON (Chair), Professor and Nutrition Clinician- Scientist, Department of Pediatrics, McMaster University ROSALIND GIBSON, Professor Emeritus, Department of Human Nutrition, University of Otago ANURA KURPAD, Professor and Head, Department of Physiology and Nutrition, St. John’s Medical College SUZANNE MURPHY, Professor Emeritus and Researcher, Epidemiology Program, University of Hawaii Cancer Center JOHN MUYONGA, Professor, Department of Food Technology and Human Nutrition, Makerere University ANN PRENTICE, Director and Head, Nutrition and Bone Health Research, Medical Research Council Elsie Widdowson Laboratory, University of Cambridge HEE YOUNG PAIK, Director, Center for Gendered Innovations in Science and Technology Research, Korea Federation of Women’s Science and Technology Associations STANLEY ZLOTKIN, Professor, Pediatrics and Nutritional Sciences, Hospital for Sick Children, University of Toronto Health and Medicine Division Staff ANN L. YAKTINE, Study Director AMANDA NGUYEN, Associate Program Officer MEREDITH YOUNG, Senior Program Assistant ANN L. YAKTINE, Director, Food and Nutrition Board 1  The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. ­ The responsibility for the published Proceedings of a Workshop rests with the workshop r ­ apporteurs and the institution. v PREPUBLICATION COPY—Uncorrected Proofs

Reviewers This Proceedings of a Workshop was reviewed in draft form by indi­ viduals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical com- ments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evi- dence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this proceedings: CELINE DUMAS, European Food Safety Authority VALERIE FRIESEN, Global Alliance for Improved Nutrition ALICE LICHTENSTEIN, Jean Mayer-U.S. Department of Agriculture (USDA) Human Nutrition Research Center on Aging SIMIN MEYDANI, Jean Mayer-USDA Human Nutrition Research Center on Aging Although the reviewers listed above provided many constructive com- ments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by DIANE BIRT, Iowa State University. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the N ­ ational Academies and that all review comments were carefully consid- ered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. vii PREPUBLICATION COPY—Uncorrected Proofs

Contents ACRONYMS AND ABBREVIATIONS xv 1 INTRODUCTION 1 Defining the Problem: Partner Panel, 4 Organization of This Proceedings, 7 2 BACKGROUND FOR THE WORKSHOP 9 Overview, 9 Harmonizing the Nutrient Intake Values: Phase 1, 10 Applications and Uses of Nutrient Intake Recommendations, 17 3 HARMONIZATION FRAMEWORKS 21 Overview, 21 Framework Consultation Process: Key Issues and Conclusions, 23 Endpoints: Differences When Considering Deficiency Versus Chronic Disease, 28 Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease: Highlights of the Consensus Report, 35 Discussion, 38 ix PREPUBLICATION COPY—Uncorrected Proofs

x CONTENTS 4 CURRENT MODELS FOR ESTABLISHING INTAKE RECOMMENDATIONS 43 Overview, 43 Dietary Reference Intakes: Harmonized Nutrient Standards for Canada and the United States, 45 South Australia and New Zealand, 46 South Korea: 2015 Dietary Reference Intakes for Koreans, 48 United Kingdom, 50 Discussion, 51 5 EXPLORING APPROACHES TO EVALUATING THE EVIDENCE 57 Overview, 57 Tools for Evaluating Strength and Quality of Evidence, 59 Global Systematic Reviews: How Can It Be Done?, 65 Risk–Benefit Assessment of Foods in a European Perspective, 72 Discussion, 79 6 CONTEXTUAL FACTORS: HOST, DIET/ENVIRONMENT, AND HEALTH STATUS 83 Overview, 83 The Role of the Host: Genetic Variation, 86 The Role of the Host: Physiology Adaptation, 93 The Role of Health Status: Infection, 96 The Role of Health Status: Aging, 100 The Role of Diet and Environment in Setting Nutrient Bioavailability Factors for Estimating Dietary Requirements, 105 The Role of Diet on Nutrient Bioavailability: Issues for Habitual Diets of Asian Countries, 110 Discussion, 113 7 BREAKOUT DISCUSSIONS: APPLICATIONS, FACILITATING QUALITY, AND COST-EFFECTIVENESS 117 Overview, 117 Setting the Stage, 118 Question 1: Advantages of Global Harmonization of Methodologies, 120 Question 2: Additional Resources and Expertise to Facilitate Adoption of a Harmonized Approach, 121 Question 3: Likely Barriers and Challenges to Achieving Global Harmonization, 122 Synthesis of Breakout Discussion, 123 Discussion, 124 PREPUBLICATION COPY—Uncorrected Proofs

CONTENTS xi 8 EXPLORING ADVANTAGES, BARRIERS, AND CHALLENGES TO GLOBAL HARMONIZATION OF METHODOLOGIES FOR NUTRIENT INTAKE RECOMMENDATIONS 127 Overview, 127 EURRECA (European Micronutrient Recommendations Aligned), 130 EFSA (European Food Safety Authority), 132 Africa, 134 Norway, 135 Southeast Asia, 136 Discussion, 138 9 MOVING THE CONVERSATION FORWARD 143 Chair’s Closing Summary, 143 Chair’s Three Strategic Messages, 145 REFERENCES 147 APPENDIXES A Workshop Agenda 155 B Speaker And Facilitator Biographies 161 PREPUBLICATION COPY—Uncorrected Proofs

Boxes, Figures, and Table BOXES 1-1 Statement of Task, 2 2-1 Overview of Points Presented by Individual Speakers, 10 3-1 Overview of Points Presented by Individual Speakers, 22 4-1 Overview of Points Presented by Individual Speakers, 44 5-1 Overview of Points Presented by Individual Speakers, 58 6-1 Overview of Points Presented by Individual Speakers, 84 8-1 Overview of Points Presented by Individual Speakers, 128 FIGURES 2-1 Nutrient intake values (NIVs) framework developed by the 2005–2007 international harmonization initiative, 16 2-2  Risk of inadequacy and risk of excess as a function of observed level of intake, 18 2-3  Group-level intake distribution as a function of intake, 18 xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv BOXES, FIGURES, AND TABLE 3-1  Evidence pyramid describing quality of evidence and risk of bias associated with different types of studies, 30 3-2  Risk of inadequacy and risk of adverse effects as a function of observed level of nutrient intake, 32 3-3  Differences in the risks of chronic diseases versus toxicity with increasing nutrient intake levels, 34 5-1  flow chart of events that occur during a study, with the seven A different types of biases that can occur along the way, 60 5-2  The nutrition-specific QAI developed by Wells and colleagues, for Health Canada, with the same internal validity checklist as in the original SIGN 50 QAI, plus the newly developed nutrition-specific section and a revised overall assessment section, 63 5-3  Generic analytic framework for a systematic review of studies on the associations between a nutrient and health outcomes, 68 5-4  Analytic framework for vitamin D and/or calcium and associated health outcomes, 69 5-5  Analytic framework for vitamin D and/or calcium and associated safety-related (adverse) outcomes, 70 5-6 Population distribution versus intake for a hypothetical nutrient, 75 5-7  Risk–benefit curve showing risk of effects associated with deficient intake, risk of adverse effects associated with excessive intake, and the lack of risk associated with intake at the safe upper limit, 77 6-1  Maps of lactose tolerance phenotype frequencies and predicted lactose tolerance phenotype frequencies based on lactose tolerance- associated allele frequencies, 89 6-2  The Bayesian model used by WHO (2015) to develop its new guidelines for red blood cell folate concentrations for women of reproductive age, 91 6-3 Dose–response curve computed from the Bayesian model used by WHO (2015), overlaid with clinical data from Daly et al. (1995), 92 TABLE 5-1  Predicted public health burden (DALYs) associated with different levels of flour folic acid fortification, 76 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations ADI acceptable daily intake AHRQ Agency for Healthcare Research and Quality AI adequate intake AMDR acceptable macronutrient distribution range ANR average nutrient requirement BMI body mass index BMR basal metabolic rate CACFP Child and Adult Care Food Program CCHS Canadian Community Health Survey CNV copy number variant CV coefficient of variation DAA data abstraction assistant DALY disability-adjusted life year DEXA dual-energy x-ray absorptiometry DFE dietary folate equivalent DRI dietary reference intake DRV dietary reference value EAR estimated average requirement EFSA European Food Safety Authority EPC Evidence-based Practice Centers EURRECA European Micronutrient Recommendations Aligned xv PREPUBLICATION COPY—Uncorrected Proofs

xvi ACRONYMS AND ABBREVIATIONS EVM Expert Group in Vitamins & Minerals FAO Food and Agriculture Organization FNB Food and Nutrition Board FSANZ Food Standards Australia New Zealand GIFT Global Individual Food Consumption Tool GRADE Grading of Recommendations, Assessment, Development, and Evaluation HMD Health and Medicine Division ICN2 Second International Conference on Nutrition INL individual nutrient level IOM Institute of Medicine IUNS International Union of Nutritional Sciences IZiNCG International Zinc Nutrition Collaborative Group JAMA Journal of the American Medical Association JRI Justice Reinvestment Initiative KNS Korean Nutrition Society KRDA Korean recommended dietary allowance LDL low-density lipoprotein LOAEL lowest-observed-adverse-effect-level LRNI lower reference nutrient intake MHW Ministry of Health and Welfare NAM National Academy of Medicine NFCS National Food Consumption Survey NHANES National Health and Nutrition Examination Survey NHMRC National Health and Medical Research Council NIRC Nutrient Intake Recommendation Committee NIV nutrient intake value NOAEL no-observed-adverse-effect-level NOFA nutrients and other food substances NRV nutrient reference value PICO population, interventions/exposures, comparators, and outcomes of interest PUFA polyunsaturated fatty acid PREPUBLICATION COPY—Uncorrected Proofs

ACRONYMS AND ABBREVIATIONS xvii QAI quality assessment instrument RBC red blood cell RCT randomized controlled trial RDA recommended dietary allowance RIVM National Institute for Public Health and the Environment RNI reference nutrient intake SCF Scientific Committee on Food SNAP Supplemental Nutrition Assistance Program SNP single nucleotide polymorphism SRDR Systematic Review Data Repository UK United Kingdom UL tolerable upper intake level UN United Nations UNICEF United Nations Children’s Fund UNL upper nutrient level UV ultraviolet WCRF World Cancer Research Fund WHO World Health Organization WIC Supplemental Nutrition Program for Women, Infants, and Children PREPUBLICATION COPY—Uncorrected Proofs

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The National Academies of Sciences, Engineering, and Medicine convened a public workshop in September 2017 to explore the evidence for achieving global harmonization of methodological approaches to establishing nutrient intake recommendations. Participants reviewed current nutrient intake recommendations, discussed the feasibility of harmonizing approaches to setting such recommendations globally, examined the development of principles by which they may be applied in diverse contexts that relate to individuals or populations, or regulatory purposes, and examined perceptions and acceptance of nutrient intake recommendations by different stakeholders. This publication summarizes the presentations and discussions from the workshop.

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