The Development of DRIs 1994-2004: Lessons Learned and New Challenges: Workshop Summary (2008)

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Appendix A Workshop Agenda and Background Materials AGENDA Institute of Medicine, Food and Nutrition Board Workshop The Development of DRIs 1994–2004: Lessons Learned and New Challenges The NAS Auditorium 2100 C Street, NW Washington, DC September 18–20, 2007 ***** DAY 1 – September 18 ***** 7:30–8:30 am Registration INTRODUCTION 8:30–9:00 Welcome and Opening Remarks John Suttie, Chair, University of Wisconsin 9:00–9:30 Overview of Current DRI Framework and Issues Raised Christine Taylor, Institute of Medicine 9:30–10:00 Break 161 

162 THE DEVELOPMENT OF DRIs 1994–2004 SESSION 1 CONCEPTUAL FRAMEWORK FOR DRI DEVELOPMENT Moderator: Stephanie Atkinson, McMaster University 10:00–10:40 Current Framework for DRI Development: What Are the Pros and Cons? Robert M. Russell, Tufts University 10:40–10:55 Case Study: Applying the DRI Framework to Chronic Disease Endpoints Paula Trumbo, Center for Food Safety and Applied Nutrition, FDA 10:55–11:10 Case Study: Applying the DRI Framework to Non- Chronic Disease Endpoints Allison Yates, Agricultural Research Service, USDA 11:10–11:50 Discussion: Framework Pros/Cons; Case Studies Co-Discussants: Patsy Brannon, Cornell University, and Alice H. Lichtenstein, Tufts University 11:10–11:30 Discussion among co-discussants/presenters 11:30–11:50 Discussion open to all attendees 11:50 am– Two Perspectives: The DRI Framework 12:20 pm Perspective I: George Beaton, University of Toronto Perspective II: Janet King, University of California, Berkeley and Davis 12:20–12:30 Question and Answer Session on Perspectives 12:30–1:30 Lunch 1:30–1:45 Evaluating Evidence for DRI Development: What Are the Issues in Applying Systematic Evidence-Based Review Approaches to DRI Development? Alice H. Lichtenstein, Tufts University 1:45–2:15 Risk Assessment: Is It a Relevant Organizing Structure? Elizabeth A. Yetley, Office of Dietary Supplements, NIH 2:15–2:55 Discussion: Systematic Evidence-Based Review; Risk Assessment Discussant: Sanford Miller, University of Maryland 

APPENDIX A 163 2:15–2:35 Discussion among discussant/presenters 2:35–2:55 Discussion open to all attendees 2:55–3:15 Break 3:15–5:15 Panel Discussion: In What Ways Could the Conceptual Framework Be Enhanced? Panel Members: Cutberto Garza, Boston College; Mary L’Abbé, Health Canada; Irwin Rosenberg, Tufts University; and Barbara Stoecker, Oklahoma State University 3:15–3:35 Opening remarks from panel members 3:35–4:00 Cross-panel discussion 4:00–5:15 Discussion open to all attendees ***** DAY 2 – September 19 ***** SESSION 2 CRITERIA FOR SCIENTIFIC DECISION MAKING Moderator: Robert M. Russell, Tufts University 8:30–8:50 am Selecting Endpoints: What Are the Issues and What Are the Options for Criteria? Irwin Rosenberg, Tufts University 8:50–9:00 Discussion 9:00–9:15 Dose–Response Data: Are There Options for Dealing with Limited Data? Susan Taylor Mayne, Yale School of Public Health 9:15–9:30 Discussion 9:30–9:45 What Are the Challenges in Addressing Extrapolation/ Interpolation for Unstudied Groups? Stephanie A. Atkinson, McMaster University 9:45–10:00 Discussion 10:00–10:30 Break 10:30–10:45 What Are the Challenges in Addressing Adjustment for Data Uncertainty? 

164 THE DEVELOPMENT OF DRIs 1994–2004 Hildegard Przyrembel, Federal Institute for Risk Assessment, Berlin, Germany 10:45–11:00 Discussion 11:00–11:20 Estimating Dietary Intake: What Are the Implications for DRI Development? Amy Subar, National Cancer Institute, NIH 11:20–11:30 Discussion 11:30–11:45 Highlights of Other Important Issues: Physiological, Genomic, and Environmental Factors Cutberto Garza, Boston College 11:45 am– Discussion 12:00 pm 12:00–1:00 Lunch SESSION 3 GENERAL GUIDANCE FOR USERS OF DRIs Moderator: Mary Bush, Health Canada 1:00–1:20 pm Overview: Issues Raised About General Guidance for Users Christine Taylor, Food and Nutrition Board, Institute of Medicine 1:20–1:40 Discussion Discussant: Johanna Dwyer, Office of Dietary Supplements, NIH 1:20–1:30 Discussion between discussant/presenter 1:30–1:40 Discussion open to all attendees 1:40–2:05 Special Challenges: Planning and Assessing the Total Diet—What Are the Issues and What Are the Options for Enhanced Guidance? Suzanne Murphy, University of Hawaii Susan Barr, University of British Columbia 2:05–2:30 Discussion Co-Discussants: Patricia Guenther, Center for Nutrition 

APPENDIX A 165 Policy and Promotion, USDA, and Krista Esslinger, Health Canada 2:05–2:20 Discussion among co-discussants/presenters 2:20–2:30 Discussion open to all attendees 2:30–2:45 Break 2:45–3:10 Special Challenges: What Are the Issues Related to a Framework for Individual-Level and Group-Level Applications? Valerie Tarasuk, University of Toronto 3:10–3:30 Discussion Discussant: Gerard Dallal, Tufts University 3:10–3:20 Discussion between discussant/presenter 3:20–3:30 Discussion open to all attendees 3:30–5:15 Panel Discussion: In What Ways Could the Guidance for Users of DRIs Be Enhanced? Panel Members: Danielle Brulé, Health Canada; Mary Frances Picciano, Office of Dietary Supplements, NIH; William Rand, Tufts University School of Medicine; and Linda Van Horn, Northwestern University 3:30–3:50 Opening remarks from panel members 3:50–4:15 Cross-panel discussion 4:15–5:15 Discussion open to all attendees ***** DAY 3 – September 20 ***** SESSION 4 LOOKING TO THE FUTURE PROCESS FOR DRI DEVELOPMENT Moderator: Paul Coates, Office of Dietary Supplements, NIH 8:30–8:45 am Emerging Issues: What New Challenges Might the Future Hold? Catherine Woteki, Mars, Inc. 8:45–8:55 Discussion 8:55–9:10 Is There a Need to Enhance Transparency of the Decision-Making Process? Robert M. Russell, Tufts University 

166 THE DEVELOPMENT OF DRIs 1994–2004 9:10–9:20 Discussion 9:20–9:35 IOM Overview of Options for Stakeholder Input Linda D. Meyers, Food and Nutrition Board, Institute of Medicine 9:35–9:45 Discussion 9:45–10:00 What Are the Criteria Options for Determining When to Update/Review Existing DRIs? John Suttie, Chair, University of Wisconsin 10:00–10:10 Discussion 10:10–10:25 What Are the Considerations in Specifying “New” Nutrient Substances for DRI Study? Peter Greenwald, National Cancer Institute, NIH 10:25–10:35 Discussion 10:35–10:50 Break 10:50 am– Panel Discussion: Reflections on What We Have Heard 12:45 pm About the Process of DRI Development Panel Members: Mary Bush, Health Canada; Jean- Pierre Habicht, Cornell University; Suzanne Harris, ILSI Research Foundation; Van Hubbard, Division of Nutrition Research Coordination, NIH; and Molly Kretsch, Agricultural Research Service, USDA 10:50–11:15 Opening remarks from panel members 11:15–11:50 Cross-panel discussion 11:50–12:45 Discussion open to all attendees 12:45–1:15 Summary and Closing Remarks Chair’s Summary (John Suttie) Closing Remarks from Sponsor Representative (Paul Coates) Chair’s Close of Workshop WORKSHOP BACKGROUND MATERIALS The following background materials were made available via the IOM web- site to the general public and workshop participants for viewing prior to 

APPENDIX A 167 the workshop. The documents and the comments received can be accessed at www.iom.edu/driworkshop2007. • IOM Publication: How Should the Recommended Dietary Allowances Be Revised? (1994) • Tables: Comparisons of Outcomes/Approaches Among DRI Nutrients • International Documents: Food and Agriculture Organization of the United Nations and the World Health Organization • Paper: Risk Assessment: Is It a Relevant Organizing Structure? (Yetley) • Paper: Selection of Endpoints for Determining EARs/AIs and ULs (Cheney) • Paper: DRI Development Process; Issues Related to Extrapolation and Interpolation for Unstudied Groups (Atkinson) • Paper: DRI Development Process; Issues Related to the Adjustment for Data Uncertainty (Przyrembel) • Paper: DRI Development Process; Issues of Variability (Rand) • Paper: Approximating Dose-Response in the Face of Limited Data (Mayne) • Paper: Uses and Challenges in Applying the DRIs; U.S. Federal DRI Steering Committee • Paper: Uses and Challenges in Applying the DRIs; Health Canada • Paper: Uses and Challenges in Applying the DRIs; American Dietetic Association • Paper: Uses and Challenges in Applying the DRIs; Dietitians of Canada