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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press. doi: 10.17226/25148.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age Committee on the Application of Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations for Young Children and Women of Reproductive Age Food and Nutrition Board Health and Medicine Division A Consensus Study Report of 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 Sciences and the Bill & Melinda Gates Foundation (Grant OPP1150751) and by the Kellogg Endowment Fund of the National Academy of Sciences’ Health and Medicine Division. 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: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25148 Additional copies of this publication are available for sale from the National Academies 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. Harmonization of approaches to nutrient reference values: Applications to young children and women of reproductive age. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25148. 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 institution 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 charter 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 advice 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 consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’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

COMMITTEE ON THE APPLICATION OF GLOBAL HARMONIZATION OF METHODOLOGICAL APPROACHES TO NUTRIENT INTAKE RECOMMENDATIONS FOR YOUNG CHILDREN AND WOMEN OF REPRODUCTIVE AGE ROBERT E. BLACK (Chair), Edgar Berman Professor, Director, Institute for International Programs, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland LINDSAY ALLEN, Center Director, ARS Western Human Nutrition Research Center, U.S. Department of Agriculture, Davis, California ZULFIQAR A. BHUTTA, Noordin Noormahomed Sheriif Endowed Professor and Founding Chair, Division of Women and Child Health, Aga Khan University, Toronto, Ontario SUSAN FAIRWEATHER-TAIT, Professor, Human Nutrition, Norwich Medical School, University of East Anglia, Norwich, United Kingdom WAFAIE FAWZI, Richard Saltonstall Professor of Population Sciences, Professor of Nutrition, Epidemiology, and Global Health, Chair, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts MARY L’ABBÉ, Earle W. McHenry Professor, Chair, Department of Nutritional Sciences, University of Toronto, Ontario, Canada LAURA MARTINO, Senior Statistician, Systematic Review and Experimental Design Team, Assessment and Methodological Support Unit, European Food Safety Authority, Parma, Italy HILDEGARD PRZYREMBEL, Professor, Director, Federal Institute for Risk Assessment, Berlin, Germany EMORN UDOMKESMALEE, Senior Advisor, Institute of Nutrition, Mahidol University, Nakhon Pathom Province, Thailand Study Staff GILLIAN BUCKLEY, Study Director AMANDA NGUYEN, Associate Program Officer MEREDITH YOUNG, Senior Program Assistant ANN L. YAKTINE, Director, Food and Nutrition Board Consultants JANET KING, Professor Emeritus, University of California, Berkeley, and Davis; Senior Scientist, Children’s Hospital Oakland Research Institute, Oakland, California LESLIE PRAY, Science Writer PREPUBLICATION COPY: UNCORRECTED PROOFS v

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 thank the following individuals for their review of this report: Stephanie A. Atkinson, McMaster University Patsy M. Brannon, Cornell University Kathryn G. Dewey, University of California, Davis Susan Krebs-Smith, National Cancer Institute, National Institutes of Health Joseph Lau, Brown University School of Public Health Amanda MacFarlane, Health Canada Suzanne P. Murphy, Emerita, University of Hawaii at Manoa Patrick J. Stover, Texas A&M University System Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by M. R. C. Greenwood, University of California, Davis, and Santa Cruz, and Susan C. Scrimshaw, Tufts University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. PREPUBLICATION COPY: UNCORRECTED PROOFS vii

Preface The establishment of reference values for nutrient intakes of populations is essential for making recommendations for appropriate, safe dietary intakes and for designing nutritional interventions, such as nutrient fortification of foods. Traditionally these efforts have been directed at preventing nutrient deficiencies. Additionally, with the increasing globalization of information and identification of factors that influence the specific nutritional needs of different population groups (e.g., young children and women of reproductive age), there has been a growing appreciation for the need to develop nutrient reference values that are applicable across countries and that take into account the varying needs of different population subgroups. In recognition of this expanding range of concerns regarding the nutritional needs of populations, the United Kingdom and the United States, in the 1990s, convened a group of experts who proposed a new approach to setting nutrient intake recommendations to address these concerns. The outcome of those efforts was the development of new methodologies for setting nutrient intake values that were adopted initially in the United States in collaboration with Canada, and in the United Kingdom. Similar approaches were developed and adopted by many European and other middle- and high-income countries. In spite of these advances, the methods are challenging for countries to apply, and there has been limited guidance on when and how to adapt the values from high-income countries for use in more resource- constrained countries. While the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) have published nutrient reference values with some consideration of diverse dietary and environmental conditions, these recommendations have not been updated regularly and have not employed recent advances in methods for synthesis and analysis of evidence. In 2009, the Department of Nutrition for Health and Development of WHO established a new process and approach for developing and updating nutrition guidelines, and in 2010 a WHO Nutrition Guidance Expert Advisory Group (NUGAG) was formed to strengthen the role of WHO in providing science-based advice, evidence-informed policy, and program guidance in support of the WHO Nutrition Program. Simultaneously, the Global Network of Institutions for Scientific Advice on Nutrition was formed to provide scientific advice on nutrition and to establish nutrition recommendations and guidelines. The Global Network met in Geneva, Switzerland, in 2010 to share information about nutrition guidance and explore opportunities for collaboration as a step toward harmonization of diet- and nutrition-related recommendations and guidelines. An important outcome of the meeting was recognition of the need to synergize efforts and examine approaches for developing nutrition guidance, including the harmonization of methods for (1) assessing the evidence underpinning nutrition science and (2) developing nutrient intake recommendations and guidance to steer national policy development. Today there is greater consistency across high-income countries in the methodological approach used to derive an average nutrient requirement (AR) and safe upper intake level (UL), the two fundamental values needed for establishing nutrient intake recommendations. However, there remains considerable inconsistency across other national and international bodies, particularly in low- and middle-income countries, in the approaches used to derive nutrient intake recommendations for their populations. Moreover, there are no consistent processes in place to ensure that any such intake recommendations remain current and relevant to those population subgroups. With these activities as a backdrop, the Bill & Melinda Gates Foundation recognized the need for action toward developing a uniform and consistent basis for setting nutrient intake recommendations across countries. The foundation therefore asked the National Academies of Sciences, Engineering, and PREPUBLICATION COPY: UNCORRECTED PROOFS ix

Medicine to do two things: first, to convene a workshop to explore questions about the uses of nutrient intake recommendations, the frameworks used for their development, the status of nutrient intake recommendations globally, and experiences and expertise in methodological approaches; and, second, to convene a consensus study committee to assess methodological approaches that could be applied uniformly across countries in setting nutrient intake recommendations. The workshop provided a backdrop and a resource for the consensus study committee’s task. Specifically, the Bill & Melinda Gates Foundation asked the committee to focus on young children and women of reproductive age and to apply its findings to these target population subgroups using case scenarios informed by workshop presentations and further review of global evidence and opportunities. This committee’s work builds on the previous work of WHO, FAO, and other relevant authoritative bodies to bring international stakeholders together to exchange data, experience, and ideas in an open setting, and then to examine the current evidence, conceptualize candidate methodologies, and develop recommendations for ways to move toward the goal of standardizing methodologies for establishing nutrient intake recommendations. The committee’s analyses, findings, and recommendations are presented in this report. The report provides a framework for how stakeholders can, within the context of a country or a region’s needs and abilities, generate a uniform approach for establishing nutrient intake recommendations that take into account culturally and context-specific food choices and dietary patterns. The Committee on the Application of Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations for Young Children and Women of Reproductive Age was supported in its task by the invaluable contributions of a number of individuals. First, many thanks are owed to the members of the committee who volunteered their time and expertise to a complex and challenging task and to the preparation of this report. Their dedication to the project was commendable. Special thanks go to the contributions of Janet King, who served as a consultant to the committee. Additional thanks go to WHO and FAO for facilitating the workshop, as well as the many individuals who gave presentations at the workshop hosted at FAO headquarters in Rome, Italy. Finally, the committee wishes to acknowledge the contributions of the study staff: Gillian Buckley, study director; Amanda Nguyen, associate program officer; and Meredith Young, senior program assistant. Finally, this project benefited from the general guidance and assistance of Ann Yaktine, director of the Food and Nutrition Board. Robert E. Black, Chair Committee on the Application of Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations for Young Children and Women of Reproductive Age PREPUBLICATION COPY: UNCORRECTED PROOFS x

Contents ACRONYMS AND ABBREVIATIONS xiii SUMMARY S-1 1 Introduction Statement of the Problem 1-1 Background for the Study, 1-1 The Committee’s Task, 1-2 The Study Process, 1-3 Organization of the Report, 1-4 References, 1-4 2 Conceptual Foundations of Nutrient Reference Value Development 2-1 Background, 2-1 Nutrient Reference Values, 2-4 Guiding Principles in Setting Nutrient Reference Values, 2-6 Conclusions and Recommendations, 2-13 References, 2-13 3 A Harmonized Process for Nutrient Reference Value Development 3-1 Key Steps in the Process for Deriving Nutrient Reference Values, 3-1 Other Uncertainties to Consider When Estimating a UL, 3-17 A Framework for Deriving Nutrient Reference Values, 3-19 Findings and Conclusions, 3-20 Chapter Summary, 3-23 References, 3-23 4 Applying Methodological Approaches to Nutrient Intake Recommendations for Young Children and Women of Reproductive Age: An Assessment of Exemplar Nutrients 4-1 Harmonizing the Process for Nutrient Reference Values Using Exemplar Nutrients, 4-1 Zinc Case Analysis, 4-3 Findings and Conclusions for Zinc, 4-13 Iron Case Analysis, 4-15 Findings and Conclusions for Iron, 4-22 Proposed Solutions for Iron, 4-23 Folate Case Analysis, 4-23 Findings and Conclusions for Folate, 4-29 Proposed Solutions for Folate, 4-30 Conclusions, 4-30 Applications of Nutrient Reference Values in Low- and Middle-Income Countries, 4-31 References, 4-31 PREPUBLICATION COPY: UNCORRECTED PROOFS xi

5 Future Directions and Data Gaps 5-1 Advantages of Harmonizing Methodologies to Derive Nutrient Reference Values, 5-1 Steps Required to Encourage Commitment to the Guidelines, 5-2 Moving Forward Toward Harmonization, 5-3 References, 5-4 APPENDIXES A Glossary A-1 B Workshop Agenda B-1 C Agree II Instrument C-1 D Tools and Methods to Evaluate the Risk of Bias in Individual Studies D-1 E Scaling Methods to Extrapolate from Reference Values of One Age Group to Another E-1 F European Food Safety Authority’s Scientific Opinion on Dietary Reference Values for Protein: Growth Factors for Children 6 Months to 17 Years F-1 G Committee Member Biographies G-1 PREPUBLICATION COPY: UNCORRECTED PROOFS xii

Acronyms and Abbreviations AFSSA Agence Française de Sécurité Sanitaire des Aliments AGP acid glycoprotein AHRQ Agency for Healthcare Research and Quality AI adequate intake AMDR acceptable macronutrient distribution range ANR average nutrient requirement ANSES Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement, et du Travail AR average requirement ASEAN Association of Southeast Asian Nations COMA United Kingdom Committee on Medical Aspects of Food Policy CRP c-reactive protein CV coefficient of variation CVD cardiovascular disease D-A-CH Germany, Austria, Switzerland DH United Kingdom Department of Health DRI Dietary Reference Intake DRV dietary reference value EAR estimated average requirement EDTA ethylenediaminetetra-acetic acid EFSA European Food Safety Authority EFZ endogenous fecal zinc EURRECA European Micronutrient Recommendations Aligned FAO Food and Agriculture Organization FNB Food and Nutrition Board FZA fractional zinc absorption GRADE Grading of Recommendations, Assessment, Development, and Evaluation HMD Health and Medicine Division IDR ingestión diaria recomendada PREPUBLICATION COPY: UNCORRECTED PROOFS xiii

IDS ingestion diaria sugerida INL individual nutrient level IOM Institute of Medicine IUNS International Union of Nutritional Sciences IZiNCG International Zinc Nutrition Consultative Group LOAEL lowest observed adverse effect level LRNI lower reference nutrient intake LSC límite superior de consume LTI lowest threshold intake NHANES National Health and Nutrition Examination Survey NIV nutrient intake value NL Netherlands Food and Nutrition Council NNR Nordic Nutrition Recommendations NOAEL no observed adverse effect level NRV nutrient reference value OHAT Office of Health Assessment and Translation PICO population, interventions/exposures, comparators, and outcomes of interest PRI population reference intake PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analysis RCT randomized controlled trial RDA recommended dietary allowance RI recommended intake RN promedio de los requerimientos nutrimentales RNI reference nutrient intake SAARC South Asian Association for Regional Cooperation SADC Southern African Development Community SRDR Systematic Review Data Repository SUL safe upper level TAZ total absorbed zinc UF uncertainty factor UK United Kingdom UL tolerable upper intake level UN United Nations UNICEF United Nations Children’s Fund UNL upper nutrient level VNR valores nutrimentales de referencia PREPUBLICATION COPY: UNCORRECTED PROOFS xiv

WHO World Health Organization PREPUBLICATION COPY: UNCORRECTED PROOFS xv

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Recommended intake levels for nutrients and other dietary components were designed initially to prevent nutrient deficiency diseases in a given population, and the original methodological approach used to derive intake values did not include consideration for other applications. However, with the increasing globalization of information and the identification of a variety of factors specific to different population subgroups (e.g., young children and women of reproductive age) that influence their nutritional needs, there has been increasing recognition of the need to consider methodological approaches to deriving nutrient reference values (NRVs) that are applicable across countries and that take into account the varying needs of different population subgroups.

There is a need for guidance and recommendations about methodological approaches, as well as their potential for application to an international process for the development of NRVs, and particularly for young children and women of reproductive age. Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age examines these issues and makes recommendations for a unified approach to developing NRVs that would be acceptable globally.

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