Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 1 Dietary Guidelines Advisory Committee Meeting Date: October 30, 2008 Time: 8:42 a.m. Location: USDA South Building Jefferson Auditorium 1400 Independence Avenue, SW Washington, D.C. Meeting Conducted By: Dr. Van Horn Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 2 1 P R O C E E D I N G S 2 MS. HOUSTON: Good morning. 3 ALL: Good morning, by all. 4 MS. HOUSTON: Welcome to the Department of 5 Agriculture. I am Kate Houston, the Deputy Under 6 Secretary for Food, Nutrition, and Consumer Services. 7 It is my pleasure to welcome you today to the first 8 meeting of the 2010 Dietary Guidelines Advisory 9 Committee. Bringing you all together here today marks 10 the official beginning of one of the most important 11 responsibilities that we have in government, and as a 12 nation, to promote the health of Americans and reduce 13 risk for major chronic diseases associated with diet 14 and physical activity. As members of the 2010 Dietary 15 Guidelines Advisory Committee, you represent leading 16 medical and scientific researchers from distinguished 17 universities and scientific institutions across 18 America. We have brought you here today for something 19 much bigger than an academic exercise, however. The 20 Dietary Guidelines for Americans are the foundation for 21 federal food and nutrition policy. Simply put, your 22 work will have real impact on real people. The Dietary Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 3 1 Guidelines are the basis for the school meals programs 2 that serve more than 31 million school children every 3 day. The Guidelines help parents who want to ensure 4 that their children have the nutrition they need to be 5 healthy and strong. They help seniors, who want to 6 live active and productive lives well into their later 7 years. The Dietary Guidelines have been issued jointly 8 by the United States Departments of Agriculture and 9 Health and Human Services every five years since 1980. 10 We have a longstanding partnership and a commitment to 11 our two departments, to ensure that the development of 12 the guidelines are pursued with the highest integrity 13 and can achieve the highest impact on the health of our 14 nation. 15 With that, it is my distinct pleasure to welcome 16 the Secretary of Agriculture, Ed Schafer. 17 Secretary Schafer hails from the great state of 18 North Dakota, where he grew up spending summers on his 19 grandfather’s wheat and livestock farms. He was 20 elected Governor of North Dakota in 1992. During his 21 eight years in office, he worked to diversify and 22 expand North Dakota’s economy, reducing the cost of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 4 1 government, upgrading the state’s schools and 2 communication infrastructure, and advancing agriculture 3 were his top priorities. Secretary Schafer was sworn 4 in here, at the Department, in January of last year. 5 Since then, he has represented the Administration in 6 the final negotiations with Congress over the 2008 Farm 7 Bill, and has begun working on implementing programs 8 that will commit over $300 billion dollars over the 9 next five years, to support America’s farmers, 10 ranchers, conservation programs and nutrition. He has 11 also strengthened our food safety system with targeted 12 regulations, and has worked to advance renewable fuels, 13 expand access to foreign markets for America’s 14 agricultural producers, and encourage community efforts 15 to fight hunger. Please join me in welcoming the 16 Honorable Ed Schafer. 17 SECY SCHAFER: Thank you, Kate. Thanks for the 18 kind introduction. It’s a great day in America, ladies 19 and gentlemen. It’s a great day to gather here in the 20 Jefferson auditorium. Thank you for being with us, and 21 welcome one and all. 22 Kate, thank you also for leading this opening Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 5 1 session this morning that will begin the very important 2 work of the new Dietary Guidelines Advisory Committee. 3 And also, thank you, Kate, for your continued good 4 work. 5 I would also like to thank and recognize Under 6 Secretary Nancy Johner, for outstanding work in the 7 Food, Nutrition, and Consumer Services Mission area 8 here, at USDA. 9 It is my honor to welcome to the Jefferson 10 Auditorium Health and Human Services Director Secretary 11 Mike Leavitt. Thank you, Mike, for being with us. 12 Mike and I served as governors back in the 1990s. Now 13 we have the pleasure of serving the people of the 14 United States of America through the President here 15 today and for a few more months, but also, I mostly 16 appreciate Mike being with us here this morning, 17 because he is a very dear friend. So, thanks once 18 again to Mike for being with us. 19 The Dietary Guidelines for Americans has been 20 issued jointly by the United States Department of 21 Agriculture and the Department of Health and Human 22 Services every five years since 1980. It is important Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 6 1 work that draws on the respective expertise of both 2 Departments and helps show all Americans the way to 3 build a healthier life. Obesity rates in the United 4 States remain high, and related health problems, like 5 Type 21diabetes, hypertension and heart disease also 6 remain prominent health concerns. In fact, you know, 7 and I find this particularly disturbing, but research 8 indicates that one in three boys and two in five girls 9 born in 2000 will develop diabetes at some point in 10 time in their lives, if we don’t develop better health 11 and eating habits in our country. And this is 12 particularly important to me as well, because I have a 13 13-year-old grandson, who is a Type 1 diabetic, and 14 through good exercise and eating regimens he has been 15 able to keep it in check. But, you know, this is a 16 very disturbing statistic and something that we very 17 much have to start working on; that nutrition and 18 exercise plan. 19 Our Dietary Guidelines provide a way for the 20 Government to speak with one voice on nutrition and 21 promoting good health. The guidelines are the 22 cornerstone of our federal nutrition policy. They are Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 7 1 the basis of our federal food and nutrition programs, 2 and an invaluable source of science-based nutrition 3 advice for consumers. And they also translate 4 scientific and medical knowledge on what makes up a 5 healthful diet into messages and guidance that can be 6 easily disseminated to the public. The guidelines 7 advise Americans from ages two to 102 about how to make 8 food choices that will promote their health and help 9 reduce their risk of chronic disease. Nutrition and 10 health professionals actively promote the Dietary 11 Guidelines as a way to encourage Americans to focus on 12 their healthful diet; and USDA promotes the Guidelines 13 through many programs that serve Americans, including 14 My Pyramid, which is USDA’s interactive on-line 15 guidance system. 16 Beginning in 1985, the USDA and HHS have appointed 17 a series of Dietary Guidelines Advisory Committees made 18 up of nationally recognized experts on nutrition and 19 health. The new Dietary Guidelines Advisory Committee 20 sitting before us today will determine whether a fresh 21 review of the scientific literature is warranted, and 22 if so, they will recommend revisions needed for the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 8 1 2010 Dietary Guidelines for Americans. Based on their 2 recommendations, our Departments will work together to 3 update the data and to get the word out to consumers. 4 You know, I believe that helping Americans eat 5 right and live better is one of the most important 6 things that we do here at the United States Department 7 of Agriculture. And to help assure our efforts there, 8 the very first step to health and well-being, of 9 course, is making sure that our fellow Americans are 10 not fighting a daily battle with hunger. And that is 11 the mission that underpins the Food Stamp Program. 12 That Food Stamp Program I guess has now been renamed 13 the Supplemental Nutrition Assistance Program -- as 14 snappy name out there -- but -- as well, as the 15 National School Lunch and the School Breakfast 16 Programs, we also have a dozen or so other programs 17 that make up this Nation’s nutrition safety net. In 18 fact, we feed more people in the United States of 19 America today than the top two fast food companies 20 combined. I think we have reached a situation, as a 21 matter of fact, with our distribution programs where we 22 touch one in five American’s lives every year. But, we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 9 1 also know that the rising food and fuel costs this year 2 have made it harder for our food banks and others to 3 provide for the needy here at home. So, at USDA, we 4 have created what we call the Secretary’s Hunger 5 Initiative. I kind of thought we should call it the 6 Schafer Hunger Initiative, but we thought for 7 longevity’s sake we would call it the Secretary’s Fight 8 Hunger Initiative. But it is focused on hands-on ways 9 to fight hunger at the grass roots level. We have 10 posted a tool kit on the Secretary’s page on our 11 website: USDA.gov that tells you how to organize a 12 food drive; start a community garden; find a volunteer 13 opportunity where you live; and many other 14 opportunities on ways to help in your community to help 15 fight hunger. And I encourage you, all of you, to take 16 a look at that webpage: USDA.gov, and the Secretary’s 17 page, and think about what you could do in your 18 community to help; because this is an area where all of 19 us can make a difference. 20 So, after that brief public service announcement, 21 let me return to the business at hand and get this 22 Committee initiated. I am pleased to introduce the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 10 1 appointed members of the 2010 Dietary Guidelines 2 Advisory Committee. I would like to welcome the Chair 3 of our Committee, Dr. Linda Van Horn. Linda is a 4 Professor and Interim Chair of the Department of 5 Preventive Medicine, at the Feinberg School of 6 Medicine, at Northwest University in Chicago. Linda, 7 thank you. 8 I am also pleased to introduce our Vice Chair, Dr. 9 Naomi Fukagawa. She is a Professor of Medicine at the 10 University of Vermont in Burlington, Vermont. Thank 11 you, Naomi. 12 Thank you both for accepting these 13 responsibilities. 14 Also serving on the Committee, Dr. Cheryl 15 Achterberg, Dean and Professor of the College of 16 Education of Human Ecology, at Ohio State University in 17 Columbus, Ohio. Thank you, Cheryl. 18 Dr. Larry Apple, Professor of Medicine, at the 19 Johns Hopkins University School of Medicine in 20 Baltimore. Thank you, doctor. 21 Dr. Roger Clemens, Associate Director of 22 Regulatory Science, at the University of Southern Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 11 1 California School of Pharmacy in Los Angeles. 2 Dr. Miriam Nelson, Founder and Director of the 3 John Hancock Center for Physical Activity and 4 Nutrition, at Tuft University. Thank you, doctor. 5 Dr. Shelly Nichols-Richardson, Associate Professor 6 at the Department of Nutritional Sciences, at the 7 Pennsylvania State University, in University Park, 8 Pennsylvania. 9 Dr. Thomas Pearson, Sr. Associate Dean for 10 Clinical Research and Professor of Medicine at the 11 University of Rochester School of Medicine, in 12 Rochester, New York. Thank you, doctor -- Tom, for 13 being with us. 14 Dr. Rafael Perez-Escamilla, Professor of Nutrition 15 and Public Health at the University of Connecticut. 16 Thank you. 17 Gee, I’m feeling kind of light. I don’t have a 18 Doctor’s Degree here today. 19 But, Dr. Xavier Pi-Sunyer is with us as well. 20 There he is. Thank you. 21 Dr. Eric Rim, Associate Professor -- 22 Oh, Dr. Xavier, or Xavier is a Professor of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 12 1 Medicine at the Columbia University of Physicians and 2 Surgeons, in New York City. 3 Dr. Eric Rim, Associate Professor of Medicine at 4 the Harvard Medical School, in Boston. Thank you for 5 being with us again. 6 Dr. Joanne Slavin, Professor in the Department of 7 Food, Science, and Nutrition at the University of 8 Minnesota, in Minneapolis. 9 Dr. Christine Williams, former Professor of 10 Clinical Pediatrics, at the Columbia University College 11 of Physicians and Surgeons, in New York. 12 I want to thank you all for volunteering your 13 valuable time and expertise here to assist our 14 Departments, both the USDA and HHS, for helping 15 Americans live healthier lives. We look forward to 16 your independent review of the science and the report 17 that you will be submit to us after your work is done. 18 It is now my pleasure to ask the Chair and the 19 Vice Chair to come forward and stand with me for 20 administering the oath of office. 21 Drs. Van Horn and Fukagawa are here with us. Will 22 you please place your left hands on the Bible, and all Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 13 1 of you please raise your right hand and repeat after me 2 -- you as well, right hand up. 3 (All Members Sworn In). 4 SECY SCHAFER: I want to again thank you all for 5 your willingness to serve on this very important 6 committee, and I know your work will be instrumental, 7 as we move forward to healthier lives of the people of 8 the United States of America. Thank you one and all. 9 The Dietary Guidelines supports the President’s 10 goals as well, and that I know that both Secretary 11 Leavitt and I share that commitment, in building a 12 healthier nation. And now I will turn the podium back 13 to Deputy Under Secretary Kate Houston. 14 MS. HOUSTON: Thank you, Secretary Schafer. I am 15 now very pleased to introduce Secretary Mike Leavitt, 16 from the Department of Health and Human Services. 17 Secretary Leavitt directs the Nation’s efforts to 18 protect the health of all Americans, and provide 19 essential human services to those in need. He manages 20 one of the largest departments in the federal 21 government, more than 67,000 employees, and a budget 22 that accounts for almost one out of every four federal Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 14 1 dollars. 2 Under his leadership during the past four years, 3 the Department of Health and Human Services has 4 implemented the Medicare Prescription Drug Benefit, 5 developed health information technology standards, and 6 progressed towards transparency of price and quality in 7 health care. 8 In addition, HHS has mobilized the Nation’s 9 Pandemic Preparedness and Medical Emergency Plans; 10 developed a new strategy for the safety of imported 11 products; and globalized the efforts of the Food and 12 Drug Administration. 13 USDA and HHS have a long history of collaboration 14 on the Dietary Guidelines, and really a whole host of 15 other activities. We are honored to have the 16 Secretaries of both Departments here together, to 17 welcome the new members of the Dietary Guidelines 18 Advisory Committee. I am very honored to welcome 19 Secretary Leavitt to the stage. 20 SECY LEAVITT: Thank you very much, Secretary 21 Schafer and members of the Committee. I would like to 22 first begin by noting that we are convening on the day Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 15 1 before Halloween and I do not think there is any irony 2 lost on us about the Dietary Guidelines. Ed mentioned 3 his grandson. My daughter called me last night to 4 report that while she was bathing her three-year-old 5 son they were having a discussion about what he should 6 be for Halloween, and he had originally planned to be a 7 dinosaur, but his mother was proposing that he be 8 pumpkin. As he dried off, he grabbed his cowboy hat 9 and said, I want to be a naked cowboy. I think he has 10 changed his mind since with his mother’s help. You 11 know, Ed and I both have grandchildren and I have -- 12 Ed, I had a friend of mine describe for me why it is 13 that grandparents have such a close relationship with 14 their grandchildren, and it’s because they have a 15 common enemy. You can think about that one. 16 The Dietary Guidelines are not about keeping 17 Americans from enjoying Halloween or Thanksgiving, for 18 that matter; but they are a very important cornerstone 19 in our federal nutrition policy, and I would like to 20 suggest that it’s more than just nutrition policy. 21 This is a volley for health care reform. Compared to 22 25 years ago, as the Secretary mentioned, there are Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 16 1 roughly now three times as many overweight children. 2 There is something particularly troubling about so many 3 young Americans being overweight, but the problem is, 4 by no means, limited to children. There is an amazing 5 statistic on obesity in American adults. In 1997, only 6 three states had obesity levels that were over 20 7 percent. In 2007, just ten years later, 49 states now 8 have obesity rates over 20 percent. So, in 1997, there 9 were only three states which had 20 percent population 10 that was obese; in 2007, there was only one state that 11 didn’t have a population that was obese over 20 12 percent. Now, I would like to claim North Dakota or 13 Utah as being among those, but unfortunately they were 14 -- both fall into the category of over 20 percent. 15 The only holdout I might add is the state of Colorado, 16 which neighbors for both of us. We’ve got to start 17 getting states to cross the line the other way, and I 18 think that’s, in large measure, what this is about. I 19 want to emphasize that that statistic that I just gave 20 you is not the result of some kind of radical 21 reclassification that’s been made. In fact, if you 22 look at the CDC website, you will see a color-coded Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 17 1 map, and it actually is timed by year. It looks like 2 election night, as they go from one color to the next. 3 The only problem is here this is a clear victory for 4 obesity, and we’ve got to change that. It’s becoming a 5 serious chronic health problem, and it’s leading to a 6 lot of chronic diseases. The types of foods that we 7 eat, as well as the amount of food that we eat is 8 having a profound impact on the health of this country. 9 More and more Americans are suffering from chronic 10 conditions, such as coronary heart disease, strokes, 11 high blood pressure, Type 2 diabetes. The cost of 12 treating chronic conditions is enormous. It makes up 13 75 percent of the $2 trillion dollars that we spend as 14 a country. I had a startling statistic presented to me 15 yesterday. Among our Medicare population, which makes 16 up more than 40 million Americans, who are seniors or 17 disabled, we have found that there are 23 percent of 18 that population that has multiple chronic diseases; 19 more than five. Of that amount they make up 67 percent 20 of the total expenditures. So, if five percent -- or 21 rather, 23 percent, making it 68 percent -- I might add 22 that these people have 37 doctor appointments every Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 18 1 year, on average, and they have as many as 50 2 prescriptions a year. This is right at the heart of 3 our health care reform issues. And, as I say, this is 4 not just a -- this is a volley in health care reform 5 that we are launching today. To bring it down to a 6 more personal level, it means that the average American 7 is spending about $10,000 a year, whether directly or 8 through taxes, to treat chronic diseases. 9 So the work of this Committee and others that will 10 be done in the development of these guidelines is a 11 very important work, and there are changes in American 12 lifestyles in the past 25 years that have resulted in 13 this overweight and the change in diets, and we need to 14 identify them. Eating well and being active is very 15 important; not just to eat well, but we need to be 16 physically fit. Earlier this month, at HHS, through 17 the good work of Penny Royall, who is part of this 18 group, we announced the 2008 Physical Activity 19 Guidelines. We encourage Americans to find something 20 active they can do; something that they are willing to 21 do, and then just to do it. The Guidelines’ central 22 message is be active in your own way. Pick an activity Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 19 1 that’s easy, fits into your lifestyle and do it at 2 least 10 minutes a day or 10 minutes at a time. More 3 is better, but some is certainly better than none. The 4 Dietary Guidelines will be complimentary to the 5 Physical Activity Guidelines, and they will incorporate 6 aspects of both of them. 7 Nearly five years ago, when Agriculture and HHS 8 last released the Dietary Guidelines we made three 9 changes to previous versions. We included more 10 comprehensive physical activity recommendations and we 11 focused on making dietary guidelines more evidence- 12 based, and we developed more consumer-friendly ways to 13 communicate the recommendations. Those were clear 14 steps in the right direction. Now these Physical 15 Activity Guidelines go hand-in-hand with a good diet, 16 and the more we can ultimately communicate both of them 17 to the public, the more useful they will be. Those of 18 you who are serving on the Committee are well aware of 19 how challenging it is to get people to change the way 20 they eat; and with that in mind, I would like to make a 21 specific suggestion to you. If you can, I think it 22 would be very useful, if you could identify the two or Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 20 1 three dietary changes that Americans can make 2 immediately that would likely have the greatest benefit 3 to their health. If you could help identify the two 4 or three, those two or three things can make the most 5 difference and it would be very helpful. 6 Now, I would like to perform my official task here 7 today, which is to make a formal charge to each of you 8 as Committee members. The Dietary Guidelines for 9 Americans provide science-based advice for Americans 10 ages two and older. In order to promote health and to 11 reduce the risk of major chronic diseases through diet 12 and physical activities, the Dietary Guidelines for 13 Americans form the basis of federal nutrition policy, 14 nutrition standards, nutrition programs and nutrition 15 education for the general public that are published 16 jointly by USDA and HHS every five years. The Dietary 17 Guidelines Advisory Committee shall advise the 18 Secretaries of HHS and USDA if revisions to the Dietary 19 Guidelines for Americans of 2005 are warranted on the 20 preponderance of scientific and medical knowledge 21 currently available. The Committee, whose duties are 22 time-limited and solely advisory in nature, will inform Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 21 1 the Secretaries of the Departments if no changes to the 2 Dietary Guidelines of 2005 are warranted. This action 3 will disband the Dietary Guidelines Advisory Council. 4 You would inform the Secretaries of both the 5 Departments if the changes are warranted based on the 6 preponderance of the current scientific and medical 7 knowledge, to determine the issues of change that need 8 to be addressed. They shall also place their primary 9 focus on the review of scientific evidence published 10 since the last Guidelines were deliberated; place their 11 primary emphasis on the development of food-based 12 recommendations; and prepare and submit a report of 13 technical recommendations with rationales to the 14 Secretaries. The Guidelines Advisory Committee’s 15 responsibilities do not include translating the 16 recommendations into a policy or a communications 17 document. And, if you are wondering when you are 18 released, you may disband upon the submittal of the 19 Committee’s recommendation via report of the Guidelines 20 Advisory Committee on Dietary Guidelines for Americans 21 2010. Now that concludes your official charge. So may 22 I with that wish you your very -- we wish for your best Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 22 1 work. We express our appreciation for your service and 2 look forward to a collaboration that will produce 3 better health for all Americans. Thank you. 4 MS. HOUSTON: With that, we are going to have an 5 official picture taken with the two Secretaries and the 6 sworn-in Committee members. So, do we have a staging 7 area for the picture? They are going to come to the 8 front. Okay. Great. 9 I am now pleased to introduce Dr. Gayle Buchanan, 10 who is USDA’s chief scientist and the Under Secretary 11 for our Research, Education, and Economics mission 12 area. This mission area includes four agencies: the 13 Agricultural Research Service; the Cooperative State 14 Research Education and Extension Service; the Economic 15 Research Service; and the National Agricultural 16 Statistic Service. Most of these include research 17 activities that are directly relevant to the 18 development of the Dietary Guidelines for Americans. 19 Dr. Buchanan will describe some of these activities in 20 his presentations this morning. I want to personally 21 thank Dr. Buchanan for his leadership at the 22 Department, and for his partnership with Food Nutrition Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 23 1 Consumer Services, in putting together the Advisory 2 Committee. Thank you, Dr. Buchanan. 3 DR. BUCHANAN: Well thank you very much for that 4 introduction and it’s certainly a pleasure to be here 5 this morning. And I think that having both Secretaries 6 here to share this opening session is a reflection of 7 the importance that both of our Departments hold for 8 this effort, so that, I think, is not lost on any of 9 us. 10 Well, on behalf of the -- 11 (Discussion off the record). 12 Well I’ll go ahead. On behalf of the Research, 13 Education, Economics Mission Agencies, I would like to 14 also welcome each of the members of the Committee and 15 also express my appreciation for the effort that you 16 make on behalf of our effort, in accomplishing the 17 goals as outlined by the two Secretaries. 18 I think you know that ensuring that all Americans 19 have access to safe, nutritional foods is the primary 20 part of the mission of the U.S. Department of 21 Agriculture. We carry out this responsibility by 22 administering numerous food assistance and nutrition Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 24 1 programs, such as food stamps, WIC, various child 2 nutrition programs and other areas. The Research, 3 Education, Economics Mission area carries out this 4 mission by both conducting intramural research in human 5 nutrition, as well as economic research related to 6 nutrition, and by supporting nutrition research and 7 education programs. Primarily, the Nation’s land grant 8 universities and other universities have nutrition 9 research and efforts. 10 The REE Mission area includes the Agricultural 11 Research Service, the USDA’s primary in-house research 12 agency that conducts research on a broad range of food 13 and agricultural issues, including human nutrition. 14 The Economic Research Service, which conducts 15 economic research for the USDA and policy makers. 16 The Cooperative States Research and Education and 17 Extension Service, which will soon become the National 18 Institute for Food and Agriculture, provides extramural 19 research support and extension support funding to the 20 land grant universities and other universities around 21 the country. 22 (Discussion off the record). Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 25 1 DR. BUCHANAN: I apologize. But anyway, the 2 Cooperative States Research Education Extension Service 3 provides extramural funding for universities, and we 4 have extension offices in every county, almost in every 5 county in the United States, which has a nutrition 6 responsibility, along with all other responsibilities 7 for supporting agricultural interests. 8 The National Agricultural Statistic Service does 9 not have a direct responsibility in nutrition, but also 10 collects a lot of data information that can be used in 11 support of the nutrition effort. 12 Moving on to the Agricultural Research Service is 13 a program that provides for intramural research and is 14 somewhat different than other federal agencies engaged 15 in nutrition research. ARS takes a food-based approach 16 to improving with emphasis on the needs of normal 17 healthy adults and children and not the biomedical 18 aspects of food. ARS has the capacity for long-term 19 studies, and has projects based on five-year plans of 20 work. ARS laboratories have state-of-the-science 21 equipment and facilities for human research across the 22 life cycle. We also have multidisciplinary research Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 26 1 approaches and tie nutrition with agriculture research, 2 to improve the American food supply. 3 The components of ARS Nutrition Research Program 4 includes nutrition monitoring and the food supply; the 5 scientific basis for dietary guidance for health 6 promotion; disease prevention; provision of obesity and 7 related diseases; life stage nutrition and metabolism. 8 I would like to emphasize that ARS also conducts food 9 safety research as a separate program in our research 10 effort; however, food safety cuts across all program 11 areas, including nutrition from farm to table, and I 12 think we all recognize that that’s an important part of 13 the food picture. 14 ARS carries out much of its nutrition research at 15 USDA’s six human nutrition research centers around the 16 country. These centers provide research that covers 17 all phases of the life cycle from infancy through old 18 age. ARS celebrated the 30th anniversary of this 19 network of Human Nutrition Research Centers last year. 20 In fact, I am leaving today for a visit to the center 21 that’s located down in Houston at the Children’s 22 Hospital, in conjunction with Baylor University. Three Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 27 1 of the centers focus on nutritional needs of adults; 2 the Western Human Nutrition Research Center at the 3 University of California Davis; the Grand Forks Human 4 Nutrition Center at Grand Forks, North Dakota; and the 5 Beltsville Human Research Nutrition Center in 6 Beltsville, Maryland. Two of the centers focus on 7 nutritional needs of children: the Children Nutrition 8 Research Center at the Baylor College of Medicine in 9 Houston, where I am going this afternoon; and the 10 Arkansas Children’s Nutrition Center at Little Rock, 11 Arkansas. And, the Jean Mayer Human Nutrition Research 12 Center on Aging at Tuft University, Boston, 13 Massachusetts addresses the needs of older Americans. 14 This year ARS initiated its first full multi- 15 center nutrition study focusing on barriers and 16 facilitative to adhering to the Dietary Guidelines for 17 Americans. They will study this in children and adults 18 at locations near the Human Nutrition Research Centers. 19 Additionally, areas have smaller projects at other 20 locations around the country; several of these address 21 different aspects of human nutrition. 22 I had the opportunity the first year I was -- the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 28 1 first month I was in office as Under Secretary for 2 Research, Education, and Economics, of meeting with all 3 of the Directors of the Human Nutrition Research Centers, 4 and I can tell you, I have never seen a more dedicated 5 group of laboratory directors, because they take their 6 work seriously. In fact, they commented we have more 7 ARS laboratories devoted to production of food than we 8 have for nutrition. It should be equal. I said, well 9 that’s not quite possible. But, they certainly are a 10 dedicated group of laboratory directors who believe in 11 the work that they are doing. 12 ARS’ role in establishing the Dietary Guidelines 13 for Americans can be summarized as finding out how food 14 nutrition promote health and prevent diseases by 15 conducting research for the scientific basis for 16 dietary guidance. This research accounts for about 70 17 percent of nutrition research programs. We also are 18 concerned about finding out what foods Americans eat 19 and finding out what’s in foods; nutrients and other 20 food components that benefit human health. Certainly 21 all of these are very important parts of the research 22 portfolio of the Agriculture Research Service. In Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 29 1 addition to the in-house nutrition research that USDA 2 carries out and ARS, the USDA funds many more 3 research projects through the Cooperative States Research 4 Education Extension Service, and that’s the agency that 5 I mentioned that will be transitioned according to the 6 passed Farm Bill into the National Institute of Food 7 and Agriculture. 8 We fund programs at the Nation’s land grant 9 universities and other universities through competitive 10 programs, and we provide federal extramural research 11 and extension funding primarily to the land grant 12 institutions, but other institutions that have research 13 efforts. The Dietary Guidelines for Americans are an 14 integral part to the work of the CSRES and the 15 Cooperative Extension System, as it relates to human 16 health, food safety, food security, and nutrition. 17 Currently, about 20 active projects directly address 18 the implementation of the Dietary Guidelines. 19 The largest source of competitive through CSRES is 20 the National Research Initiative. Under the NRI there 21 are two focus areas for nutrition research; health 22 benefits of nutrients and other bioactive food Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 30 1 components; obesity prevention, including development 2 of successful intervention. For fiscal year 2008, 3 CSRES awarded 30 NRI grants totaling $15.9 million 4 dollars related directly to the Dietary Guidelines and 5 its implementation. 6 Another program that I am very fond of and one 7 that I had a very specific involvement in, in the state 8 before I left Georgia, which is Expanded Food Nutrition 9 Program. CSRES manages this program, which operates in 10 all 50 states and six U.S. territories. This program 11 is designed to teach our low income people with the 12 knowledge, skills, and attitudes, and change behavior 13 necessary for a nutritionally sound diet. The program, 14 which has both adult and youth components, also helps 15 people in their personal development and improved 16 nutrition within the entire family. This program is 17 administered through the County program with leadership 18 provided at the state level and the land grant 19 universities in the respective states. 20 I am also pleased that, in a number of states, 21 this is a cooperative leadership program between the 22 1890s and 1862 programs, because this is a program that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 31 1 touches all segments of our society. Power 2 professionals usually live and work in the respective 3 counties and the areas in which these program are 4 administered. It is a very challenging program, 5 because you are working with some of the people that 6 have some of the greatest needs, but I can tell you 7 that the benefits and the effort that people make in 8 making this program successful is very, very 9 impressive. The program reaches young people. It 10 provides nutrition, education in schools and after- 11 school programs through 4-H day camps, residential 12 camps, community centers, neighborhood groups, home 13 gardening workshops, and all other ways in which we can 14 reach people. The Dietary Guidelines for Americans 15 provides a foundation for essentially all of the 16 nutritional educational programs that we administer 17 through the Cooperative States Research Education 18 Extension Service. 19 The Economic Research Service conducts economic 20 analyses on many aspects of food and agriculture in 21 support of USDA’s mission. The ERS has a large 22 intramural research program that focuses on food Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 32 1 consumption, food safety, food security and diet health 2 outcomes. Economic Research Service also publishes in- 3 house peer reviewed articles and also sitting articles 4 for the Journal of Nutrition, Journal of American 5 Dietetic Association, and other journals that are 6 appropriate. The Economic Research Service also 7 conducts studies and evaluations of the Nation’s 15 8 different food and nutrition programs. These programs 9 include food stamps, WIC, child nutrition programs, 10 such as school lunch and breakfast program, et cetera. 11 And these reports really give us the assurance that the 12 money that we are allocating for these programs is 13 going to the right places and doing the right job, and 14 having a definitive analysis by the Economic Research 15 Service is a very important part of accountability of 16 these programs. 17 This research provides the Administration and 18 Congress, and other program managers, assurance that 19 the food assistance we are providing is reaching the 20 right people and doing the job that we expect. 21 These are just a few of the examples of the 22 Economic Research Service projects that have examined Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 33 1 important policy-related topics in the area of 2 nutrition, food safety and health. All of these 3 projects result in ERS research reports available on 4 the ERS website and is available to anyone that would 5 like to have them. 6 I hope I have given you just a very, very brief 7 introduction to the role of the various agencies in the 8 Research, Education, and Economic mission area at 9 the U.S. Department of Agriculture, and about our 10 commitment to the federal nutrition research and support 11 of the Dietary Guidelines for Americans. The USDA is 12 committed to ensuring that all Americans have access to 13 the highest quality, safest and most nutritious food 14 supply anywhere, and REE is committed to providing the 15 best science to support those efforts. I want to once 16 again thank all members of the Dietary Guidelines 17 Committee for your time and effort in helping us 18 improve the nutrition and diets of all Americans. 19 Thank you very much. 20 MS. HOUSTON: With USDA’s distinct honor of being 21 the lead agency for the 2010 Dietary Guidelines, it 22 gives me great pleasure and we have great faith in the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 34 1 process in the hands of the Center for Nutrition Policy 2 and Promotion, which is part of our mission area in the 3 food, nutrition and consumer services area of USDA. 4 I am going to turn over the podium to Dr. Robert 5 Post. We are honored to have Dr. Post as the Deputy 6 Director for the Center for Nutrition Policy and 7 Promotion. Dr. Post has done a tremendous job and has 8 shown great leadership in putting together this 9 committee, and I am now going to turn the podium over 10 to him. 11 I think this is the end of my remarks here. So, 12 in closing, I just want to say again, thank you to the 13 Committee for your willingness to serve in such an 14 honorable capacity. Food is such a basic human need 15 and it sounds so simple on one hand, but on another, 16 it’s also a very complex issue. It brings out other 17 issues dealing with personal health and well-being, and 18 issues of academic success and of economic and 19 individual productivity, and even issues of national 20 security. I think we have heard today how incredibly 21 important the Dietary Guidelines can be in an 22 investment of an activity that can make such a profound Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 35 1 effect on reducing health care costs and improving the 2 lives of so many Americans. So, the job before you is 3 a great one and we thank you so much for your service. 4 With that, I will turn it over to Dr. Post, who will 5 continue to be your Master of Ceremonies for the 6 remainder of the day. Thank you very much. 7 DR. POST: Well, good morning, and thank you, 8 Deputy Under Secretary Houston and also Under Secretary 9 Buchanan, for your remarks this morning. I am very 10 glad to be here and personally welcome you to the first 11 meeting of the 2010 Dietary Guidelines Advisory 12 Committee, and review some important points related to 13 the operations of the Dietary Guidelines Advisory 14 Committee. I suppose there is always one of us rules 15 people in every crowd and I happen to be that person, 16 and I don’t take that lightly. With the expertise from 17 Advisory Committees, such as this one, federal 18 officials and the Nation have access to information and 19 advice on a broad range of issues affecting federal 20 policies and programs. The public, in return, is 21 afforded an opportunity to participate actively in the 22 federal government’s decision-making process. Federal Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 36 1 advisory committees, such as this one, are governed by 2 the Federal Advisory Committee Act or FACA. 3 FACA was established by Congress in 1972, to 4 assure that advisory committees provide advice that is 5 relevant, objective and open to the public; act 6 promptly to complete their work; and comply with 7 reasonable cost controls and recordkeeping 8 requirements. Consistent with FACA rules, each public 9 meeting will be announced in the Federal Register 10 through a public notice. As part of the open, 11 transparent process, the meetings of the full committee 12 are open to the public, and any deliberations that 13 occur between meetings, such as those in topic-specific 14 subcommittees, are brought back to the full committee 15 at a public meeting. 16 The public also has opportunities to participate 17 in the process by providing written comments to the 18 Committee through our on-line public comment database, 19 and that’s located at www.dietaryguidelines.gov, as 20 well as they are given the opportunity to present brief 21 oral testimony before the Committee at one public 22 committee meeting. And likely, this will be the second Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 37 1 Dietary Guidelines Advisory Committee meeting. The 2 public can submit written comments for the Committee 3 throughout the time period that the Committee is 4 operating. Generally, however, in order for comments 5 to be handled efficiently for the committee members 6 before a meeting, the Federal Register notices will 7 advise on a date by which comments should be submitted, 8 to be considered for the next Dietary Guidelines 9 Advisory Committee meeting. The public will also have 10 an opportunity to submit comments to the Federal 11 Government, in response to the release of the 12 Committee’s Advisory Report. 13 Now, in addition to these rules of the FACA, I 14 would also like to review some rules of engagement. 15 The Dietary Guidelines Advisory Committee members need 16 to refer any individuals who contact them personally to 17 solicit information about their work on the Committee 18 to the Dietary Guidelines Management Team, and I’ll 19 have an opportunity to recognize them a little later 20 on. Committee members have been advised that they 21 should not give presentations as a member of the 22 Committee about the Committee’s work, or speak as a Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 38 1 representative of the Committee, as this would be 2 inconsistent with Advisory Committee operations, and 3 would preclude the transparency, the requirement that 4 the Committee’s work be transparent to the public. 5 And lastly, I would also like to thank you for 6 your willingness to serve on this Committee. Its work 7 has critical importance in advising the federal 8 agencies on the best and most current nutrition 9 guidance for all Americans, and I am certainly honored 10 to be part of this process. 11 And, at this point, I would like to turn the 12 meeting over to the Chair, Dr. Van Horn. 13 DR. VAN HORN: My task now is, first of all again 14 to welcome everyone on the Committee. It’s wonderful 15 to officially have this opportunity to launch, and my 16 job now is just to review the agenda that lay before 17 us. 18 This morning we’ll have several presentations that 19 will provide background on the Dietary Guidelines for 20 Americans. Robert Post, our Deputy Director of the 21 Center for Nutrition Policy and Promotion of USDA will 22 provide a brief historical overview of the Dietary Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 39 1 Guidelines. Brian Wansink, Executive Director of the 2 Center for Nutrition Policy and Promotion will discuss 3 the role of the Dietary Guidelines in nutrition 4 programs and policy within USDA. Penny Royall, Deputy 5 Assistant Secretary for Health for the Office of 6 Disease Prevention and Health Promotion of HHS, will 7 discuss the role of the Dietary Guidelines in health 8 promotion programs and policy within HHS. We will then 9 hear an overview of the state of the American diet 10 based on healthy people 2010 data from Cliff Johnson, 11 Director of the Division of Head and Nutrition 12 Examination Service -- Health and Nutrition Examination 13 Services at the National Center for Health Statistics 14 of HHS, and also healthy eating index data from 15 Patricia Guenther, from the Center for Nutrition Policy 16 and Promotion of USDA. After lunch, Joan Lyon, from 17 the Center for Nutrition Policy and Promotion will 18 discuss the nutrition evidence library followed by two 19 areas of scientific discussion by the Committee; 20 nutrient adequacy and fluid and electrolytes. 21 Now, Dr. Robert Post, Deputy Director of the 22 Center for Nutrition Policy and Promotion, has some Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 40 1 additional introductions of individuals and will go 2 over some housekeeping items, then we’ll be taking a 3 brief break. 4 DR. POST: I’d like to thank Secretary Schafer and 5 Secretary Leavitt, and the Under Secretary of Research 6 Education and Economics for their participation this 7 morning. And, also I’d like to thank Deputy Under 8 Secretary Houston for leading the opening session. 9 At this time I’d like to introduce a few other 10 individuals who are critical to the operations of the 11 Committee, and in order to see them I stepped up here 12 to the podium. I’d like to first introduce our Co- 13 Executive Secretaries to the Dietary Guidelines 14 Advisory Committee. Carole Davis is the Director of 15 the Nutrition Guidance and Analysis Division of the 16 Center for Nutrition Policy and Promotion, and is also 17 the designated federal officer for the Dietary 18 Guidelines Advisory Committee. Shanthy Bowman, who is 19 out here, if you’d like to stand -- is a nutritionist 20 at the Beltsville Human Nutrition Research Center of 21 the Agricultural Research Service of USDA. Kathryn 22 McMurry is a Senior Nutrition Advisor at the Office of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 41 1 Disease Prevention and Health Promotion in the 2 Department of HHS. And, Holly McPeak is a nutrition 3 advisor also in the office of Disease Prevention and 4 Health Promotion at the Department of HHS. There are 5 also other members of the Dietary Guidelines’ 6 management team staff and the nutrition evidence 7 library staff, who are instrumental in this process, 8 and I would like for them to stand as well. Obviously, 9 we are -- we take it seriously and devote resources to 10 this. 11 Well, at this time, I would like to take a moment 12 to talk about a few housekeeping announcements. Just 13 as you need a rules person, you need a housekeeping 14 person as well. And before we take a 15-minute break, 15 let me remind you of some things. Before you forget, 16 please remember to turn off cell phones during the 17 meeting. The badges you received, when entering 18 through security must be worn while in the building, 19 and must be left at security when exiting the building. 20 If you leave the building for any reason, you will need 21 to leave your badge behind and retrieve it at re-entry. 22 You will repeat this process, if you are joining us, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 42 1 and I hope you will be, for the meeting tomorrow. 2 Audio, videotaping and photographing are not allowed, 3 as they are disruptive to the meeting proceedings. 4 Following the meeting, the meeting Minutes will be 5 posted on the Dietary Guidelines’ .gov website. This 6 time I didn’t use the www. This is also where you can 7 submit and view public comments. When entering and 8 exiting the building, please use wing 7. Wheelchair 9 accessibility is available at the wing 1 entrance. And 10 perhaps of most importance for a full-day meeting, I am 11 advised that non-government individuals here today 12 should use the restrooms at wings 5 and 6 outside of 13 this auditorium. And, on that note, we will reconvene 14 promptly at 10:00 a.m., according to our schedule. 15 Thank you. 16 (Whereupon, at 9:40 a.m., a brief recess is 17 taken). 18 DR. POST: Could I please ask everybody to take 19 your seats? We are almost ready to start. Thank you. 20 DR. VAN HORN: it’s my pleasure to formally 21 welcome Dr. Robert Post. Dr. Post is the Deputy 22 Director of USDA Center for Nutrition Policy and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 43 1 Promotion. Dr. Post came to the Center with over 26 2 years of industry, government and academic experience 3 in food and nutrition research, food processing, public 4 health communications and education in food policy. 5 Prior to joining the Center, he led USDA’s Labeling 6 Policy Program, where he established the rules on 7 nutrition labeling, and he created and directed the 8 Department’s Joint Food Additive Approval Program with 9 the Food and Drug Administration. Dr. Post is also an 10 adjunct faculty member of the Nutrition and Food 11 Science Department at the University of Maryland, and 12 it’s my pleasure to introduce Dr. Rob Post. 13 DR. POST: Thank you. Not only am I a rules 14 person; I am also a perspectives person, and my 15 presentation is intended to provide some perspective in 16 terms of the history of the Dietary Guidelines. 17 Now, from the start, the Dietary Guidelines for 18 Americans were intended to establish the direction and 19 standards for all government nutrition programs, 20 including research, education, food assistance, 21 labeling, and nutrition promotion. And since 1980, in 22 their first iteration, they have become more Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 44 1 comprehensive, as the science research on which they 2 are based has evolved. 3 So you might be asking, what are the Dietary 4 Guidelines? They represent federal nutrition policy 5 set by both USDA and HHS that provides science-based 6 advice for Americans two and older, to help promote 7 health and prevent chronic diseases related to diet. 8 The Dietary Guidelines serve as the cornerstone of the 9 federal nutrition policy and education, and advocate 10 that Americans choose a more healthful lifestyle that 11 balances nutrition and physical activity. The Dietary 12 Guidelines provide nutrition policy for federal 13 programs, as we heard this morning; such as the 14 National School Lunch Program, WIC, and the 15 Supplemental Nutrition Assistance program formerly 16 known as food stamps. They are also the core of 17 federal nutrition education initiatives, as we’ll hear 18 later; such as My Pyramid, Eat Smart Play Hard, and 19 also the Small Steps Program at HHS. Working jointly, 20 USDA and HHS ensure that messages and materials are 21 consistent throughout the Federal Government, and that 22 the Federal Government speaks with one nutrition voice. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 45 1 Before the 1970s, public health and nutrition was 2 primarily concerned with preventing deficiencies. As 3 deficiency diseases became less common, it led to a 4 growing recognition of diseases related to dietary 5 excesses. 6 Some points of interest in time, in 1977, the U.S. 7 Senate Select Committee on Nutrition and Human Needs 8 issued Dietary Goals for the United States. These 9 goals were the focus of controversy among some 10 nutritionists and others concerned with food nutrition 11 and health. And later, in 1979, the American Society 12 for Clinical Nutrition formed a panel to study 13 relationships between dietary practices and health 14 outcomes and the findings were reflected in Healthy 15 People, the Surgeon General’s Report on health 16 promotion and disease prevention. Now this early work 17 pointed to the need for national guidelines that were 18 regularly updated and based on the preponderance of 19 current science and medical knowledge. 20 The Dietary Guidelines were first published in 21 1980. Section 301 of the National Nutrition Monitoring 22 and Related Research Act of 1990 was promulgated later Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 46 1 by Congress mandating the Secretaries of the USDA and 2 HHS to jointly publish the Dietary Guidelines for 3 Americans at least every five years. Once the Dietary 4 Guidelines Advisory Committee is appointed, it meets to 5 review the science and draft a scientific advisory 6 report, which is submitted to the Secretaries of Health 7 and Human Services and USDA. During the deliberations 8 of the Dietary Guidelines Advisory Committee, the 9 public has opportunities to provide comments through an 10 on-line database and also in person at one of the 11 upcoming meetings. There will be about four or five 12 meetings of the Dietary Guidelines Advisory Committee, 13 plus substantial work conducted between the meetings. 14 The meetings occur over a two-year process, and the 15 Dietary Guidelines Advisory Committee’s work is done 16 once they submit their Advisory Report to the 17 Secretaries. 18 The Advisory Report contains nutrition information 19 for the general public based on current scientific and 20 medical knowledge, and this will be a rather large 21 document, in our view, and the Report that was used to 22 write the Dietary Guidelines Policy was about 350 Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 47 1 pages. USDA and HHS use the Advisory Report to 2 establish the Federal Dietary Guidelines Policy. 3 The Dietary Guidelines for Americans were first 4 issued, or first released in 1980 and revised 5 subsequently in 1985, 1990, 1995, 2000, and of course, 6 2005, and these are the various printed versions of the 7 policy documents from the past. 8 I mentioned earlier that the Dietary Guidelines 9 have become more comprehensive over time. The 1995 10 Dietary Guidelines were the first to include the 11 concept of balancing dietary intake with physical 12 activity to maintain a healthy weight, which was 13 supported by various tools; such as, the Food Guide 14 Pyramid, nutrition facts, and a healthy weight chart. 15 In 2000, new concepts were addressed. These were 16 the first Dietary Guidelines to expand to 10 guidelines 17 and three focus areas built on the concepts aiming for 18 fitness through balancing intake and physical activity; 19 building a healthy base by consuming enough of certain 20 foods; and choosing foods sensibly in moderation. The 21 areas of food safety and physical activity were new 22 additions to these guidelines. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 48 1 The current Dietary Guidelines, published in 2 January 2005, expanded to 41 recommendations, and there 3 are nine topic areas, which are listed here, with 23 4 specific messages for the general public and 18 for 5 special population groups. And in terms of the weight 6 or the volume of the document, the 2005 edition of the 7 policy was about 70 pages in length. And you can see 8 here the focus area is focused on adequate nutrients 9 within calorie needs; weight management; physical 10 activity; food groups to encourage -- the five food 11 groups to encourage; fats -- those that are beneficial 12 and others that might be of concern; carbohydrates; 13 added sugar; sodium and potassium and electrolytes in 14 general; alcoholic beverages; and certainly food 15 safety. 16 If you wanted a snapshot of the Dietary Guidelines 17 2005 and the recommended food pattern changes, it’s 18 probably easily seen as a matter of recommending 19 changes to food consumption that generally require more 20 of certain things and less of others. So, in this 21 case, more fruits, dark green vegetables, orange 22 vegetables, legumes, whole grains -- make at least half Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 49 1 your grains whole, low fat milk and milk products and 2 physical activity. These are in the more list. And 3 certainly then recommendations related to less intake 4 with regard to saturated fats, trans fats, cholesterol, 5 added sugars, refined grains and sodium. 6 Now questions in topic areas that Committee 7 decided were in need of review were identified by the 8 previous committee. The revision process to the 2000 9 Dietary Guidelines was led by Health and Human Services 10 in 2005. There were 13 members on that Dietary 11 Guidelines Advisory Committee; five public meetings 12 were held; and eight sub-committees evaluated data on 13 scientific questions. And, in this area, a systematic 14 review of the literature was used to determine the 15 preponderance of nutrition and medical knowledge to 16 respond to the Committee’s specific scientific 17 questions. 18 The resources on which the 2005 Dietary Guidelines 19 Advisory Committee based its report included these 20 inputs: Institute of Medicine Reports on Dietary 21 Reference Intakes related to macronutrients, 22 electrolytes, antioxidant vitamins and micronutrients; Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 50 1 and also considered was the 2003 International Agency 2 for Research on Cancer Handbook for cancer prevention 3 on fruits and vegetables. And also, making a point 4 that I made previously, other literature was compiled 5 using an evidence-based review approach. 6 Some other features of the 2005 Dietary Guidelines 7 relate to how they were implemented. A policy guide 8 and a brochure targeted at consumers were developed 9 subsequent to the policy document publication. The 10 process for their development involved an evidence- 11 based review of current science; a 2000 calorie 12 reference diet created consistency between the 13 guidelines and nutrition facts; energy balance and BMI 14 were central themes; and a substantial amount of 15 consumer research was conducted to support the messages 16 for consumer outreach and education. 17 Sort of one of these snapshots here, you can look 18 at the Dietary Guidelines process graphically. The 19 Guidelines are based on numerous scientific and 20 clinical studies on food, nutrients and physical 21 activity requirements for health promotion and the 22 prevention of chronic diseases. This slide is a Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 51 1 graphic representation of the development of the 2 Guidelines and how they are used for informing 3 consumers. 4 The left part of the screen shows publications of 5 quantitative nutrient guidelines; dietary reference 6 intakes issued for different nutrients. The DRIs are 7 developed by the Food and Nutrition Board Institute of 8 Medicine, from a comprehensive analysis of available 9 information about nutrient requirements. 10 The center is the evidence-based report on diet 11 and health developed by the Dietary Guidelines Advisory 12 Committee Report, which I had mentioned before was 13 about 350 pages. This federally-appointed committee of 14 experts reviewed the most current science and provides 15 consensus recommendations, as I mentioned, to the 16 Departments of Health and Human Services and the 17 Secretary of Agriculture. This report is further 18 refined by the Secretaries of HHS and USDA into the 19 Dietary Guidelines for Americans 2005, and that’s the 20 document that’s about 70 pages. That’s in the center 21 of the screen. And that then represents federal food 22 and nutrition policy for the country. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 52 1 The Guidelines are then used as a basis for 2 developing consumer information, such as consumer 3 brochures for the general public, and I think we have 4 some examples here that are both from USDA and HHS; My 5 Pyramid food guidance system; USDA’s more matters 6 program; the -- which is -- I’m sorry, the pyramid is 7 USDA’s; more matters by the Centers for Disease 8 Control; milk matters; National Institute of Child 9 Health and Human Development Program in the National 10 Institutes of Health; the DASH eating plan -- NHLBI is 11 responsible in NIH for that; expenditures on children; 12 the cost of raising a child; food plans developed by 13 the Center for Nutrition Policy and Promotion; the 14 Healthy Eating Index; WIC -- the WIC food package; SNAP 15 -- the Supplemental Nutrition Assistance program; and 16 other nutrition education efforts that are just too 17 numerous to count. So, as you can see, there is a 18 great deal of magnification once the policy document is 19 issued, and we’ll hear more about that later on this 20 morning. 21 So, how are these revisions to the Dietary 22 Guidelines made? The process is virtually the same as Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 53 1 that used for each Dietary Guidelines revision cycle, 2 and it’s what we will be following for the 2010 Dietary 3 Guidelines process. It is an appointment of the 4 Committee, as I mentioned earlier; the holding four to 5 five public meetings through an open public process; 6 accepting public comments throughout the deliberation 7 period; an advisory board of recommendations will 8 ultimately be developed and presented and presented to 9 the Secretaries of HHS and USDA, and from that then 10 there is a joint development of policy and consumer 11 materials. And HHS and USDA jointly published the 12 Guidelines and consumer information. 13 In terms of some specifics, as I probably 14 explained already, in terms of the 2010 Dietary 15 Guidelines, a Memorandum of Understanding was the first 16 thing that was created in creating the recognition of 17 the need for the 2010 Dietary Guidelines Advisory 18 Committee. In June, a charter to operate the Committee 19 was signed by both Secretaries. The nominations for 20 the Dietary Guidelines Advisory Committee were made and 21 selections were made over the last few months, and 22 obviously now the first meeting is in progress, and I Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 54 1 have taken a bold step here by saying the rest will be 2 history. 3 One new feature that we have added is the 4 nutrition evidence library, which will be discussed in 5 more detail this afternoon. And, on that note, it 6 might be worthwhile pointing to the sources of evidence 7 for use by the 2010 Dietary Guidelines Advisory 8 Committee. The nutrition evidence library will be one 9 of many sources the Committee will be able to use, as 10 part of their evidence-based review of the literature, 11 in order for them to determine whether a revision of 12 the Dietary Guidelines will be necessary; and if so, 13 what types of recommendations will lead to their 14 Advisory Committee report. As you can see, the newest 15 evidence-based review is highlighted in light blue, the 16 new 2008 Physical Activity Guidelines, which will be a 17 resource I’m sure for this Dietary Guidelines Advisory 18 Committee. 19 As you know, with each revision of the Dietary 20 Guidelines, the goal is to produce positive changes in 21 the dietary and physical activity behaviors of 22 Americans, and it starts with the Dietary Guidelines Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 55 1 that are firmly based on the best science available, 2 with the Dietary Guidelines as the foundation promoting 3 dietary changes means developing effective 4 communication and education strategies; testing and 5 retesting materials for target audiences; building 6 strategic alliance across agencies within the federal 7 government; and in terms of public/private 8 relationships, certainly stimulating the opportunity 9 for healthier choices to be available to consumers, and 10 then ultimately helping the media and industry see that 11 the win-win means recognizing the attention and 12 credibility, and the ability to provide a synergistic 13 effect that is greater than what each sector can 14 achieve individually to help consumers. 15 Something very important to the process for the 16 2010 Dietary Guidelines, a better way to communicate 17 everything related to the Dietary Guidelines is to make 18 it as transparent a process as possible. And, to make 19 information easy to locate, we created this website: 20 www.dietaryguidelines.gov; and it’s going to be updated 21 each time new information is available and it’s our way 22 of providing the public and the committee members a one Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 56 1 stop location in meeting all of their dietary 2 guidelines needs. 3 And, on that note, if the members of the Committee 4 have questions, I’ll take them. If the general public 5 has questions, you can always forward them to the 6 Center for Nutrition Policy and Promotion, if you have 7 them. Thank you. 8 DR. VAN HORN: Thank you, Rob. Next we will have 9 two presentations on putting the Guidelines into 10 action. It’s my pleasure to welcome Dr. Brian Wansink. 11 Dr. Wansink was appointed in November of 2007 as the 12 Executive Director for USDA Center for Nutrition Policy 13 and Promotion. He also is the John S. Dyson Professor 14 of Marketing and the Director of the Cornell Food and 15 Brand Lab, in the Department of Applied Economics and 16 Management at Cornell University. He came to CNPP with 17 over 25 years of experience in nutritional science, 18 food psychology, consumer behavior and food marketing. 19 Thank you. 20 DR. WANSINK: Thank you, very much. Now for this 21 part of the presentation, what we are going to do is we 22 are going to talk about where the rubber meets the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 57 1 road, in terms of the Dietary Guidelines. Now, the 2 Deputy Assistant Secretary for Health, Penny Royall, and 3 I will be doing this. But, on behalf of both of us, I 4 want to mention some other people. Now for the last 5 two months we have been talking embracing the Committee 6 for all the work that lies ahead and the bumpy road 7 that will be there. That road has been tremendously 8 smoothed out over the last five months by a group of 9 people that are joint from HHS and USDA in setting up 10 this Committee. I want to acknowledge those people, 11 and I would like them to stand just so you can really 12 see who they are. For HHS, Kathryn McMurry please; 13 Holly McPeak; Eve Essery; Shirley Blakely; for the 14 USDA, we’ve got Carole Davis; Kellie O’Connell -- can 15 you come up, Kellie; Colette Rihani; and then Shanthy 16 Bowman. Please help me give them a hand. Thank you 17 very much. Now I do that not just so the Committee can 18 see the names and faces of the people who have been 19 corresponding with them for the last few months and not 20 just so you can see there is a whole lot of people 21 involved in this, not just the Committee, but so that 22 they also know that their late nights and sleepless Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 58 1 nights sometimes is not being overlooked or 2 unappreciated. Thank you. 3 Within the past week I had a chance to talk to 4 somebody who was a member of the 2005 Dietary 5 Guidelines, and this person said something very unusual 6 to me. He said, when I started that Committee in 2005, 7 he said, “I was skeptical that anything we would come 8 up with would make a difference.” In the same sentence 9 he then said, “...but I was wrong.” He went on to say 10 that within three months of the Committee being 11 completed all of a sudden he saw food companies 12 reformulating products; putting whole grains in things 13 that hadn’t been whole grains. Within a year there 14 were new fruits and vegetables that you typically 15 didn’t find; dark orange, dark green vegetables you can 16 find in grocery stores at a reduce rate. Well that 17 just shows what happened in the marketplace, and that’s 18 the tip of the iceberg. 19 What we are going to talk about now is what 20 happens in these agencies that has a tremendous impact 21 on people. The USDA has seven what’s called mission 22 areas. You can see them right here. Now those seven Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 59 1 mission areas, what we do touches five of the seven 2 mission areas. I want to talk about that and that’s 3 going to be the basis of my program. 4 Let’s start with the Food, Nutrition and Consumer 5 Services. The Food Nutrition Service Program is a $60 6 billion dollar program. Now, it includes SNAP, which 7 is formerly food stamps, and their -- the guidelines, 8 informed policies and benefit levels. In the school 9 meal programs, the Guidelines help determine nutrition 10 standards and meal pattern requirements. In the WIC 11 Program, they guide the composition of the WIC food 12 packages. In the Commodity Food Distribution Programs, 13 food specifications conform to the Guidelines. And 14 finally, across FNS programs, the Guidelines form the 15 basis for all the nutrition efforts, education efforts 16 we do. Now what I want to do is talk about these 17 programs individually. 18 Here is what was known as the Food Stamp Program 19 -- the Food Stamp Program, we used to call SNAP, and 20 more than 28 million people receive SNAP benefits every 21 month, and approximately half are children and 90 22 percent are over the age of 60. The average benefit Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 60 1 per person is $101.50. In April 2007, the USDA 2 announced a version of the Thrifty Food Plan and that’s 3 the basis for setting the maximum food stamp 4 allotments. The Thrifty Food Plan is based on the 2005 5 Dietary Guidelines, and I will be saying more about 6 that in just a few minutes. When it comes to SNAP, we 7 also have new educational materials, and the Guidelines 8 inform all of these. The goal is to help participants 9 make healthy food choices within a limited budget and 10 choose physically active lifestyles consistent with the 11 current Dietary Guidelines for Americans and My 12 Pyramid. And I think also we have translated these 13 into Spanish, and there are over 400 -- 4.5 million 14 pieces that have been developed for this. 15 For the school meal programs, that’s basically 16 what a lot of us know as the hot lunch program and the 17 school breakfast program. Over 30 million school 18 children receive these meals each school day. 19 And with the SNAP Program, like I said, the theme 20 is called loving your family and feeding their future. 21 It’s a comprehensive nutrition program aimed at getting 22 mothers to make the right decisions about what they are Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 61 1 buying, or whoever is going to be buying the food. 2 The school meal program, like I said, over 30 3 million people receive meals in the school meal program 4 each day. All school meals must meet the Guideline 5 recommendations, and we have an IOM contract that 6 aligns meal patterns with nutrition standards in the 7 2005 Dietary Guidelines. 8 In terms of education materials, what we provide 9 are fact sheets for the new menu planners giving 10 practical tips in sodium, cholesterol and trans fat 11 levels, and show how to use fruits, vegetables, whole 12 grains and dried beans in a way where it is not left on 13 the train; in a way where it actually gets eaten. We 14 are also helping schools move toward the 2005 Dietary 15 Guidelines, and one of the ways that we are doing this 16 at FNS is that we have a healthier U.S. school 17 challenge, which encourages schools to provide more 18 nutritious meals and opportunities for physical 19 activity, but it also awards the schools that are doing 20 a good job with this with either bronze, silver or gold 21 awards based on the Dietary Guidelines. 22 The WIC Program, over eight million low-income, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 62 1 pregnant, post-partum and breast-feeding women, infants 2 and children receive WIC food packages each month. 3 Half of all the babies born are born into a WIC 4 household. That’s how important this is. WIC food 5 packages -- are aligned with 2005 Dietary Guidelines and 6 the rules issued in December 2007, the participants 7 receive nutritious foods, nutrition counseling and 8 referrals to health and other social services. 9 The USDA foods -- there is also the Commodity Food 10 Distribution Food Program. Thirty years ago we used to 11 call this Government Cheese, but I know now it’s called 12 the Commodity Food Distribution Food Program, and its 13 nutrition assistance to low-income families, emergency 14 feeding programs,Indian Reservations and the elderly. 15 Now the Farm Bill enabled us to -- the USDA to increase 16 fruit, vegetable and whole grain purchases in this 17 Commodity Food Distribution Program, and it compliments 18 ongoing efforts to bring the USDA foods into alignment 19 with the Dietary Guidelines in similar proportions. 20 Now, we are going to talk about research education 21 and economics, and you heard Dr. Buchanan, he spoke a 22 little bit earlier, this is his agency as the Under Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 63 1 Secretary. The Cooperative State Research Education 2 Extension Service is a mouthful, but we basically know 3 it as the State Extension Service. These provide 4 national leadership for community-based nutrition 5 education programs and it sponsors nutrition-related 6 research. The Dietary Guidelines are used at CREES, or 7 the Extension Service, for strategic planning; for 8 creating research grant opportunities; for delivering 9 all of their educational material messages in 10 evaluating program effectiveness actually using our 11 HEI, our Healthy Eating Index, which Dr. Post mentioned 12 and you’ll hear more about today. 13 The Expanded Food Nutrition Education Program 14 (EFNEP), the Dietary Guidelines are the foundation of 15 all of EFNEP’s educational programming. It operates in 16 all 50 states and in six U.S. territories, and reaches 17 a half million low-income families and youth each year, 18 and the education there focuses on dietary 19 recommendations, nutrition practice, food resource 20 management skills, and then food safety. 21 The Economic Research Service (ERS), those are all 22 a bunch of economists, and they measure food Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 64 1 consumption daily against dietary standards, using the 2 Dietary Guidelines as a standard for a healthy diet. 3 In doing so, they use the ERS Food Availability Data 4 System. You can see a little sample of a map there 5 that shows sort of food is available and how much is 6 actually consumed. And they use these analyses in a 7 lot of food consumption survey data. You might have 8 heard of NHANES -- this is the group. 9 ARS, Agricultural Research Service, they define 10 the role of food and components in optimizing health by 11 conducting high priority research. 12 The National Program on Human Nutrition, there are 13 a bunch of things here, but we have just one example, 14 and it’s what we eat in America. It monitors the 15 extent of adherence by the American public to the 16 Dietary Guidelines, and here is where the NHANES comes 17 in and is used vigorously. 18 So, in the USDA we are not going to look at 19 marketing and regulatory programs. The Ag Marketing 20 Service (AMS) administers programs to facilitate 21 efficient fair marketing of U.S. agricultural products. 22 Within that group the Dietary Guidelines are used to Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 65 1 guide decisions on purchasing products for the Federal 2 Nutrition Assistance programs setting specifications 3 for the products that are purchased and overseeing 4 Commodity Board research and promotion programs. 5 Food Safety -- the Food Safety Inspection Service 6 educates consumers about the importance of safe food 7 handling and how to reduce the risks associated with 8 food-borne illness. That was a tough agency to be with 9 this last year, I think. Implementing the Dietary 10 Guidelines Food Safety recommendations through its many 11 food safety education programs and campaigns, and they 12 do so through Thermie the Thermometer; be Safe; Fight 13 Back; and other programs like this. 14 Natural resources in the environment -- well, we 15 are actually involved with the U.S. Forest Service. 16 They’ve got something called Kids in the Woods Program, 17 and what we do -- they implement the Dietary Guidelines 18 by engaging children of all ages in nature-based 19 activities to enrich their lives and promote health 20 through outdoor experiences. 21 And last, Food Nutrition and Consumer Services, 22 I’m going to talk about -- well, CNPP, the Center for Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 66 1 Nutrition Policy and Promotion. We’ve got a number of 2 things I’m going to talk about; the first is food 3 plans. The Dietary Guidelines directly influence the 4 food plans. The thrifty food plan is the one that 5 most people are familiar with. It determines the types 6 and quantities of foods needed to obtain a nutritious 7 diet at minimal cost. And the nutritional basis for 8 this food plan and the three others that are low, 9 moderate and liberal, use the dietary reference 10 intakes; the 2005 Dietary Guidelines; My Pyramid food 11 intake recommendations. 12 The Healthy Eating Index, this is designed to 13 measure compliance of diets with the 2005 Dietary 14 Guidelines for Americans. It’s used to monitor the 15 diet quality of the U.S. population and the low income 16 sub-population. Dr. Post mentioned this. You’ll hear 17 more about it in detail in a little bit. Now perhaps 18 the most familiar way we implement this is through My 19 Pyramid food guidance system. It’s a major 20 implementation tool for the 2005 Dietary Guidelines for 21 Americans, and it’s based on the Guidelines of the 22 Dietary Reference Intakes. It provides messages that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 67 1 consumers can more easily understand and put in 2 practice. You’ve seen that big blue book in 2005? 3 Yeah, this makes it a lot more clearer. There are 4 interactive tools, materials that translate this 5 guidance into all kinds and amounts -- all kinds of 6 information and the amounts of food you eat each day. 7 Here is what its reach is. Since this was launched 8 back in 2005 by the former Executive Director, Dr. Eric 9 Hentges, it has had over 5.7 billion hits on the 10 website. Now, from what we understand, it’s the second 11 most accessed Government website right behind the one 12 that everybody logs onto on April 14. Okay. There are 13 3.5 million registered users on the tracker. And My 14 Pyramid menu planner, which we just launched back in 15 May, has 750,000 page views every single day. My 16 Pyramid tools and web materials; we have interactive 17 tools, like the tracker, the menu planner and the Blast 18 Off game; we have got sections for pregnant, breast- 19 feeding women, and we just launched at ADA four days 20 ago for parents with preschoolers, which was launched 21 by Patricia Britten, who led up that group. We have 22 printed materials and information for professionals, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 68 1 and we have Project M.O.M., something that is near and 2 dear to my heart, which has helped us focus our 3 energies on mothers, others and My Pyramid; the people 4 who are the nutritional gate-keepers who make the 5 decisions tonight what their family is going to be 6 eating tonight. 7 Well one thing that some of my prior research had 8 shown is that people don’t make food decisions when 9 they are sitting in front of food, nor do they make 10 food decisions when they are holding a brochure or 11 surfing the web looking for dietary advice. They make 12 them wherever they purchase food; wherever they prepare 13 food; where they work; and where they play. Now if 14 there is a way that we can connect to these people, not 15 communicate at them, but connect with these people, I 16 think we are going to be a lot more effective in 17 changing dietary habits. And we can’t do that with the 18 Government, but we can with information multipliers. 19 What I have talked about up until now is just what the 20 USDA does with these things. What we did on January -- 21 rather, on June 10this last year is we started 22 something called Partnering With My Pyramid. What we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 69 1 did is we challenged companies to think of a way that 2 they can promote the pyramid in a way that’s consistent 3 with the Dietary Guidelines, to help their consumers 4 eat better. Now, in just less than four months, here 5 is what we have found; the pyramids showing up on 6 packaging, showing how food fits into the Dietary 7 Guidelines. It’s come up in games. You see it now in 8 supermarkets. You see it in display cases, on 9 websites, and we started with 42 companies on January 10 10 -- or rather, June 10 -- right now we are up to 11 around 70. They are coming up with innovative ways to 12 get the word out wherever people purchase and prepare 13 food; wherever they work; and where they play. 14 I am tremendously grateful and I am tremendously 15 proud to have had the opportunity not just to work with 16 the people at the CNPP, but to work with the 17 department, the USDA, that I think is the department of 18 the people. It does a lot of things to help people eat 19 better and to be healthier. Thank you. 20 DR. VAN HORN: It’s my pleasure to welcome Rear 21 Admiral Penelope Royall, the Deputy Assistant Secretary 22 for Health and Director of the Office of Disease Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 70 1 Prevention and Health Promotion in the United States 2 Department of Health and Human Services. She is a 3 senior health advisor to the Assistant Secretary for 4 Health and to the Secretary of HHS. Rear Admiral 5 Royall is responsible for strengthening the disease 6 prevention and health promotion priorities of the 7 Department within the collaborative framework of the 8 HHS agencies. RADM. Royall. 9 RADM. ROYALL: Good morning, everyone. This is a 10 great day for all of us who care about health. We are 11 embarking on the, the next journey that will lead us 12 towards the state of the science in nutrition and 13 health, and I am so excited and I welcome all members 14 of the Committee. I especially want to thank Larry 15 Appel and Xave Pi-Sunyer for signing up again. These 16 two folks helped us with 2005, and they had such a good 17 time that they decided to come back. I also want to 18 especially thank Mim Nelson, who has just finished 19 being on our Advisory Committee for Physical Activity 20 Guidelines, and Mim, here she is to be the bridge 21 between the Physical Activity Guidelines and Dietary 22 Guidelines, so it’s so great to know we are so much fun Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 71 1 in the government that we have people who are willing 2 to come back. 3 As Dr. Wansink just told you about the many, many 4 programs in USDA that rely on and use the Dietary 5 Guidelines, I wanted to just give you a very brief 6 overview of what happens at the Department of Health 7 and Human Services, and most of the things I am going 8 to mention to you today are consumer guidance that 9 attempt to push the Dietary Guidelines for Americans 10 out to the ground floor where things really happen. 11 Dietary Guidelines are developed -- are used in our 12 food assistance programs, like Meals on Wheels -- you 13 have heard of that for the elderly citizens of America, 14 and the development of national health objectives. 15 Healthy People 2010 is coordinated in the Office of 16 Disease Prevention and Health Promotion, but we 17 couldn’t move very far without the National Center for 18 Health Statistics. Cliff Johnson is here to talk to 19 you in just a few minutes about how we are really 20 eating in America. I’m not sure it’s great news, but 21 we’ll hear from Cliff in just a minute. 22 The Dietary Guidelines also influenced the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 72 1 questions in national nutrition monitoring in NHANES. 2 You all are aware, I am sure, of the NHANES survey that 3 is done by the Centers for Disease Control and 4 Prevention of HHS. Dietary Reference Intakes and food 5 fortification policies are all influenced by the 6 documents that are produced by Committees like this. 7 Similar to USDA, HHS has programs that impact 8 Americans of all ages and from different cultural 9 backgrounds and educational levels. This is 10 tremendously important. You know, when I hear of all 11 the unbelievable things that the Department of 12 Agriculture does to promote good education, and I am 13 very familiar with what we do at HHS. It begs the 14 question, why are we not more successful? I -- there 15 is something that we need to address, and I haven’t 16 quite put my finger on it yet, but we make strong 17 efforts, dedicated people all over the country are 18 working on this. I think having Brian Wansink here at 19 CNPP was a stroke of genius, and if I could, I would 20 tie a rope around him and not let him leave. We need 21 all the marketing help we can get to make a difference 22 for the American people. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 73 1 The first program I am going to mention is one 2 that’s a collaboration across the government, including 3 HHS and USDA, and that is the Healthier U.S. Program. 4 We all work together to promote a healthier country, 5 and the initiative is based on the simple idea that 6 individuals can make a difference in their own lives. 7 As a matter of fact, as a clinical psychiatric social 8 worker, I am here to tell you that it all comes down to 9 individual choices. Yes, the environment is important, 10 absolutely, but we cannot guarantee that if you build 11 it they will come. This is about individual people 12 making individual choices to affect the entire 13 population. 14 The Dietary Reference Intakes calls for a lot of 15 collaboration across the government. The DRIs are a 16 comprehensive set of nutritional references for healthy 17 populations. It’s established through a review process 18 overseen by the U.S. Food and Nutrition Board at the 19 Institute of Medicine. The Institute of Medicine, as I 20 think all of you know, is a scientific advisory body to 21 the federal government. The DRIs are considered by the 22 U.S. and the Canadian government in helping develop a Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 74 1 variety of policies and programs to benefit health, and 2 we are very pleased that the Institute of Medicine has 3 recently initiated a study to review Dietary Reference 4 Intakes on vitamin D and calcium. That’s been in the 5 news. I know all of you have seen the articles on 6 vitamin D and calcium intake. 7 Here are lists of HHS agencies. You know we are 8 all about health at the Department of Health and Human 9 Services. The Administration on Aging, listed first, 10 utilizes the Dietary Guidelines in their nutrition 11 services. They are the organization that manage the 12 Meals on Wheels Program. Of course, the Centers for 13 Disease Control and Prevention promote the Dietary 14 Guidelines in Fruits and Veggies, More Matters -- I’m a 15 little behind -- There are some other programs that the 16 CDC pushes. All of this stuff, all of these programs 17 are manned by people who really care about the health 18 of the country. The Weight Management Research to 19 Practice Series is an evidence-based program that the 20 CDC manages. The More Matters replaces the popular 21 Five-A-Day Program that, at one time, was located at 22 the National Institutes of Health and was moved to the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 75 1 CDC, because the CDC is really the sort of hands and 2 feet of the public for HHS, and we felt that perhaps it 3 would move faster further if it was moved from our 4 esteemed research area of the National Institutes of 5 Health. 6 The Food and Drug Administration also relies on 7 Dietary Guidelines in their nutrition facts labels. 8 They have programs to educate consumers on this facts 9 label. We know that people want things quick and easy. 10 Sometimes quick and easy is not always the best, and 11 the FDA has made efforts to educate consumers on how to 12 use the nutrition facts label. The Spot the Block 13 Program for tweens and Make your Calories Count is an 14 interactive program that FDA manages. The FDA, as well 15 as the CDC, along with USDA collaborate on food safety. 16 Food safety programs range from general recommendations 17 to recall foods, warnings, advisories, et cetera, and 18 combating food-borne illness is a top priority at the 19 Food and Drug Administration. 20 The Health Resources and Services Administration 21 launched the Bright Futures Initiative way back in 22 1990, and that program is still viable, active and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 76 1 moving forward. The Nutrition Bright Futures Guide is 2 now being revised with HRSA and the American Academy of 3 Pediatrics, and it will continue to be based on the 4 Dietary Guidelines for Americans. 5 The Indian Health Service -- this is the agency in 6 HHS that serves our Native American populations. Many 7 of you know that these Americans suffer 8 disproportionately from the diseases to which improper 9 nutrition contributes. Their Strength in the Family 10 Circle handouts are based on culturally meaningful 11 images, high impact messages and personal success 12 stories, along with current nutrition science. 13 Honoring the Gift of Children is another IHS program 14 that promotes sound parenting skills using healthy 15 eating and physical activity as examples. 16 Now, back to the National Institutes of Health. I 17 certainly did not mean to disparage this unbelievable 18 agency when I said that the Fruits and Veggies, More 19 Matters has moved to CDC. Not only is it the premier 20 research institution at HHS, but they do have some 21 programs over there all of course science and evidence- 22 based. One of my favorite is We Can -- Ways to Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 77 1 Enhance Children’s Activity and Nutrition, which is an 2 education program for caretakers and parents of 3 children from eight to 13. It is to help this 4 population, which is one of the populations in which 5 overweight and obesity seems to blossom, to keep these 6 kids at a healthy weight. 7 Portion Distortion -- golly, have you been out to 8 eat lately? It’s unbelievable the amount of food that 9 we have put on our plates when we -- when we eat. And 10 we all then begin to become accustomed to that and just 11 eat it all up. We clean our plates. And that was in 12 the day that, as you heard earlier, where nutrition 13 deficiencies were big in this country. Thank God we 14 don’t have many nutrition deficiencies now, but we sure 15 do have a problem with overeating. 16 The DASH Eating Plan out of the National 17 Institutes of Health, along with the USDA - My Pyramid 18 are two examples of eating plans that exemplify the 19 Dietary Guidelines. 20 In the Office of the Assistant Secretary for 21 Health, where my office lives, the Office on Women’s 22 Health has come out with a terrific program called Body Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 78 1 Works. It is an adolescent obesity prevention program 2 that focuses again on parents and role models, and it 3 provides tools for parents to make choices to influence 4 their own family. There are materials in this, 5 although it is from the Office of Women’s Health, 6 materials for adolescent boys has been added to this 7 tool kit making it a program for healthy teens and 8 strong families. The Indian Health Service has adopted 9 the Body Works Program and is currently pilot-testing 10 Body Works for Native Americans. Also, there is a 11 Spanish version of the program and these materials will 12 be available soon. 13 My office, the Office of Disease Prevention and 14 Health Promotion, is involved in various activities 15 across the spectrum for preventing disease and 16 promoting health. We developed consumer materials, 17 such as A Healthier You, and a bilingual booklet -- I 18 think it’s on there -- right -- El Camino Hacia Una 19 Vida Saludable -- translated to A Road to a Healthy 20 Life. This is based on Dietary Guidelines for 21 Americans. We are really excited about that. That is 22 available in paper versions, as well as on the Web. We Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 79 1 also promote Dietary Guidelines on our little website, 2 www.healthfinder.gov. We are proud of our little 3 website. It continues to win awards for being, for 4 giving reliable, validated health information, 5 especially for consumers who are not particularly 6 health literate. That’s www.healthfinder.gov. 7 www.health.gov is where the Dietary Guidelines can be 8 found, as well as on www.dietaryguidelines.gov, and 9 www.healthierus.gov is another government website that 10 has information on how to stay healthy. 11 In addition, many of the Healthy People 2010 12 objectives address nutrition and measure, in some way, 13 our nation’s progress towards implementing these 14 recommendations of the Dietary Guidelines. And, 15 Healthy People 2020 is now in the process of being 16 developed, and I feel sure we will continue to address 17 this. 18 Here again is another shot of the bilingual 19 brochure. This is the title page on 20 www.healthfinder.gov. I wanted to mention that, again, 21 we are focusing on eat healthy on this slide, but the 22 Physical Activity Guidelines were just released October Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 80 1 7, and the first screen that you will come to when you 2 click on www.healthfinder.gov right now is a be active 3 screen. So, there is a quick guide to healthy living on 4 there, again, evidence-based. We have partnered with 5 AHRQ, the Agency for Healthcare Research and Quality, 6 at HHS to present healthy things that individuals can 7 do to promote and protect their own health. 8 Here is the Physical Activity Guidelines for 9 Americans that was just released a couple of weeks ago. 10 These Guidelines came about -- let me just tell you 11 quickly -- that since 1995, there has been a mention in 12 Dietary Guidelines for Americans of physical activity. 13 The physical activity community was interested in 14 having a more comprehensive physical activity 15 guidelines document that could bring together all of 16 the documents out there that address physical activity. 17 And so, following the example of the Dietary Guidelines 18 for Americans we convened some very smart physical 19 activity scientists, who followed the same process that 20 this Dietary Guidelines process Committee is going to 21 follow. The 2008 Guidelines are the first ever 22 comprehensive Physical Activity Guidelines issued by Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 81 1 the Department of Health and Human Services. They are 2 designed to provide information and guidance on the 3 types and amounts of physical activity that provides 4 substantial health benefits for Americans ages six and 5 over. The important thing to note about the Physical 6 Activity Guidelines, vis-à-vis the Dietary Guidelines, 7 is that these were developed to provide complementary 8 and consistent advice for physical activity. The 9 general guidance ary Guidelines for 10 Americans and the comprehensive advice in the Physical 11 Activity Guidelines on physical activity will, we hope, 12 get more people up and moving. More information about 13 these guidelines will be provided to you, but a few of 14 the main messages are, be active your way. As 15 Secretary Leavitt said earlier, some is better than 16 nothing, and more is better. 17 I want to thank the Committee again. I want to 18 thank you all in the audience for coming and listening 19 to this august body as they begin their deliberations 20 on the state of the science relating nutrition and 21 health. I want to thank the Committee and emphasize 22 again the importance of your service, and I want to Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 82 1 echo Secretary Leavitt’s request that, if you can, it 2 would be useful to have you identify two or three key 3 dietary changes that can make an immediate difference 4 to the American people. As I said earlier, we have 5 programs out the wazoo. It is unbelievable the amount 6 of smart people working to try to get America to eat 7 better and move more, and we’ve still got a huge, huge 8 issue out there. So, as much as we can, let’s see if 9 we can get some simple guidance on two or three main 10 issues to the American people. Thank you all very 11 much. 12 DR. VAN HORN: Thank you, Penny. That was 13 wonderful. Next on our agenda are two presentations on 14 the state of the American diet. Our first presenter, 15 Mr. Cliff Johnson, is the Director of the Division of 16 Health and Nutrition Examination Surveys at the 17 National Center for Health Statistics, of the Centers 18 of Disease Control and Prevention. His division is 19 responsible for conducting the National Health and 20 Nutrition Examination Survey, a sizable task, I might 21 add. Mr. Johnson has been with the NHANES Program for 22 36 years this month. Congratulations. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 83 1 Our second speaker, Dr. Trish Britten, is a 2 nutritionist with the Center for Nutrition Policy and 3 Promotion of USDA. Dr. Britten has been with the USDA 4 for nine years. Her major contributions have included 5 leading the development of the My Pyramid Food Guidance 6 System and conducting the food modeling analyses used 7 in the development of the 2005 Dietary Guidelines. 8 Mr. Johnson? 9 MR. JOHNSON: Thank you. To the Committee and 10 everyone, thank you for the opportunity to come and 11 present this morning. I was asked to focus my part of 12 the state of the American diet and public health on the 13 aspects of obesity and physical activity with the next 14 presentation and presentations at a future meeting 15 spending more time on the dietary aspect of this piece. 16 What I have decided to do as part of this task is 17 to give you some brief overview of some of the sources 18 of data on diet, nutritional status and help; more 19 specifically focusing some on what has been alluded to 20 in some earlier presentations today in some of the 21 information from the Centers for Disease Control and 22 Prevention; and then more specifically, a little Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 84 1 background on NHANES since it has been mentioned at 2 least numerous times this morning, to give you some 3 background that leads into what’s being done in this 4 survey and what it has -- information available -- and 5 then show you a few selected slides that gives some 6 findings on overweight and obesity, as well as physical 7 activity, and then conclude with a couple of summary 8 comments. 9 There are numerous surveys and surveillance 10 systems throughout the federal government that provide 11 information on the state of the American diet and 12 public health, and I might also mention it’s not just 13 surveys and surveillance systems, but it’s a variety of 14 research activities that are also throughout the 15 various departments, many of which have been alluded to 16 by previous speakers. 17 Within the Centers for Disease Control and 18 Prevention there are a number of key data systems that 19 provide information related to the state of the 20 American diet and public health. In particular, they 21 are the National Health And Nutrition Examination 22 Survey or NHANES; the National Health Interview Survey; Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 85 1 the Behavioral Risk Factor Surveillance System (BRFSS); 2 and the Youth Risk Behavioral Surveillance System. 3 Focusing in on the National Health And Nutrition 4 Examination Survey as one of the key parts of this set 5 of data collection systems, NHANES has, in particular, 6 been described as a cornerstone of the Federal 7 Nutritional Monitoring System and a significant source 8 of data that would likely be of use to this Committee. 9 NHANES has its objective, and has always had its 10 objective, to assess the health and nutritional status 11 of adults and children in the United States, and that 12 is accomplished by selecting a representative sample of 13 the U.S. population and conducting interviews and 14 direct physical examinations on these persons selected 15 to participate in the survey. 16 NHANES has a variety of goals, and I have just 17 selected four to give you an example of some of them 18 today; but, as of -- the goal of the survey includes 19 the produced population-based estimates on various 20 health conditions; the awareness, treatment and control 21 of selected diseases; environmental exposures for the 22 U.S. population; and obviously of interest today, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 86 1 nutrition status and diet, and diet behaviors. 2 NHANES has existed for a long time. It actually, 3 next year, will be the 50 anniversary of the very 4 first ever health examination survey conducted by the 5 National Center for Health Statistics. Of course, the 6 nutrition component was significantly expanded in the 7 early 1970s, which led to the acronym and the current 8 survey as we know it today. So that’s when that part 9 developed. And during that course of the 1970s, 1980s 10 and 1990s, a variety of cross-sectional periodic 11 surveys were conducted. Beginning in 1999, NHANES 12 became a continuous ongoing survey conducted as two- 13 year cycles, if you will, where we leave the content 14 the same over a two-year time period and we interview 15 and examine approximately 10,000 people each -- over 16 the course of those two years. Currently, we are 17 nearing the end of the collection of the 2007-2008 18 survey time period. Extensive data from all of the 19 NHANES have been made publicly available for use by the 20 research community. 21 I want to mention that NHANES is a major 22 collaborative effort across the federal government. On Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 87 1 this slide are many of the -- are the overall many 2 federal agencies, who currently are both supporting 3 scientifically and physically the operation of the 4 NHANES survey. This is truly, as I said, a 5 collaborative effort, and you can see that all of these 6 different organizations would obviously and do have a 7 significant interest and focus, as we have heard from 8 the various presentations today related to the 9 nutritional status and dietary status of the U.S. 10 population. 11 One of these collaborations is especially 12 significant. Beginning in 2002, NHANES has served as 13 the vehicle for the collection of the National Dietary 14 Intake Data, known as What We Eat in America, and you 15 have heard it referred to a few times this morning 16 already. At that point in time, What We Eat in America 17 represents, since 2002, the integration or moving, 18 merging together of the two previous primary federal 19 dietary data collection efforts; that is, the former 20 Continuing Survey of Food Intakes by Individuals 21 conducted by USDA/ARS and the NHANES itself conducted 22 by NCHS/CDC within HHS. This collaboration is a Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 88 1 dedicated effort between the staffs of the two 2 Departments to make sure it happens. And, to give you 3 an idea of the flavor of the responsibilities, HHS, 4 through National Center for Health Statistics, is 5 responsible for the sample design and the operation of 6 the survey. USDA, and in particular ARS, is 7 responsible for the dietary methodology used in the 8 survey; all the processing of the dietary data; and the 9 nutrient values of foods through the food composition 10 databases. And jointly, the two departments monitor 11 the data collection and the data quality, and are 12 actively involved in the joint release of this data. 13 The nutrition component for NHANES is, for the 14 time periods 2003 and 2004, and 2005 and 2006 is very 15 extensive, more so than any previous time period in the 16 history of the survey. Within those four years of the 17 survey, we had 220 overall recalls and all persons 18 interviewed and examined in the survey; a non- 19 quantitative food frequency questionnaire; questions on 20 dietary supplement use; a set of dietary behavior 21 questions; body measurements; physical activity 22 questions and physical activity measures through an Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 89 1 accelerometer; and nutrition biomarkers, all at the 2 same time in the course of this survey. Because much 3 of the NHANES 2005 and 2006 data have become available 4 within the last year, many peer review publications 5 based on this information are just starting to arrive 6 in these various publications. Much more is likely to 7 occur during the next year or so of this Committee’s 8 deliberations. And again, the advantage of the 9 integration of the nutrition and dietary component with 10 NHANES health topics also allows for the very extensive 11 ability to link diet, nutrition, physical activity and 12 biomarkers to all of the other health components. 13 The results that I am presenting today will focus 14 on obesity and physical activity. They represent 15 examples from recent Healthy People progress reviews in 16 the last few months. Time constraints preclude me from 17 showing you all the findings presented at those 18 reviews, so I am just going to give you a few examples 19 from the various slides and data and information that 20 were available at those two particular progress 21 reviews. Additional information, I believe, has been 22 provided to the Committee in their briefing materials. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 90 1 It’s clear that diet, physical activity and 2 overweight/obesity are linked with respect to the 3 energy balance equation and, as shown on this slide, 4 diet is associated with many health conditions and 5 diseases and overall health status. Dietary data, in 6 particular, will be a part of the next presentation 7 and, in addition, at the next meeting, there will be 8 some additional presentations on dietary data from the 9 What We Eat in America/NHANES survey at that time. 10 The latest 2003-2006 data documents the trend in 11 increased adult obesity for both males and females 12 first demonstrated in NHANES-III. The current percents 13 of persons considered obese -- and again, as we heard 14 alluded to from the Secretaries this morning -- are far 15 greater than the Healthy People target goal of 15 16 percent. In other words, they are close to 33 percent 17 overall for the U.S. population. The trends in obesity 18 are shown on this slide, just to give you a perspective 19 of the fact that since we have been conducting NHANES 20 in a similar fashion and collecting these direct 21 physical measures ever since the 1959-1960-1962 time 22 period, we have been able to track the prevalence of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 91 1 overweight, and more specifically, as shown on this 2 slide, obesity ever since that time documenting the 3 significant change that occurred between the end of the 4 1970s and the NHANES-III 1988-1994 time period and the 5 ongoing continuation of those results from 1988-1994 into 6 the more recent 2003-2006 time period. For children and 7 adolescents, again, as we heard from previous speakers 8 this morning, the picture is very much the same as that 9 observed in adults. 10 Now turning to physical activity, physical 11 activity data comes from numerous sources of surveys 12 and surveillance systems. The benefits of physical 13 activity and fitness are shown on this slide and 14 documented in great detail in the recently released 15 Physical Activity Guidelines for Americans that RADM 16 Royall just discussed. Using data from the National 17 Health Interview Survey, one of the other data systems 18 I mentioned, this slide shows that there is no 19 significant change in the percent of adults reporting 20 moderate, leisure timed physical activity from the 1977 21 time period to 2006. Overall, approximately 30 percent 22 of the people met the criteria of regular leisure time Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 92 1 physical activity defined as shown on the note in this 2 slide. The likelihood of selected health problems, as 3 shown on this slide and is shown to be lower for those 4 persons engaged in moderate activity, as defined from 5 the previous slide. 6 Determining the activity patterns of adults and 7 children using self reports or proxy reports is 8 challenging. In the time period 2003-2006, physical 9 activity in NHANES was measured both by self reports 10 and by accelerometer. The accelerometer allows this to 11 measure the intensity and duration of common 12 activities, such as walking and running, and you can 13 see it was done on a number of the participants in the 14 NHANES survey over this four-year time period, and that 15 this allows us to link to, again, to a number of these 16 other different components that are in the NHANES 17 Survey. Using the accelerometer data from NHANES, Dr. 18 Troiano and colleagues recently published the results 19 shown on this slide. Using recommended levels defined 20 on the left axis of this slide, in terms of recommended 21 levels of physical activity, most gender and age 22 groups, population groups, had fewer than ten percent Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 93 1 meeting this criteria. The one exception was the 6-11- 2 year-old age group. And you might notice, based on 3 this slide and the one I showed a couple of minutes 4 ago, that there seems to be a much smaller number of 5 people meeting the criteria based on the accelerometer 6 than there were based on self report. 7 As with dietary intake data, there are numerous 8 methodologic challenges or issues associated with the 9 physical activity assessment. Some of them are shown 10 on this slide, and in the interest of time I won’t go 11 through each and every one of them. It’s clear that 12 there are recall issues, self report versus measured, 13 just as I alluded to a second ago, but even the 14 measured values, regardless of what assessments we are 15 doing; diet, physical activity, nutrition biomarkers 16 also have their methodologic challenges and 17 difficulties monitoring over time. And the 18 accelerometer, in particular, does not measure all 19 aspects of physical activities. So it’s still missing 20 certain aspects. What these different methodologic 21 challenges do indicate is that even though we have made 22 progress in terms of having other ways to assess Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 94 1 physical activity, much more remains to be done, and 2 hopefully, a lot of the analysis that will come from 3 this NHANES 2003-2006 time period will increase our 4 knowledge in that area, as well as the ability to link 5 it to diet and other sources of information. 6 In summary, there is extensive and fairly recent 7 data and publications available on diet, obesity and 8 physical activity, and I believe there is going to be 9 much more showing up in the literature in the next few 10 months to over the next year, since much of the NHANES 11 2005-2006 data became available over the earlier part 12 of this year, and it will not have made its way through 13 the referee journals and articles quite yet. More is 14 going to be presented by the following speaker related 15 to diet and in the future meetings of this, for this 16 Committee. And so, again, I feel like I had to do this 17 just as a touching the overall issues. There is a lot 18 more information that could be presented. Well, I 19 thank you for your attention. 20 MS. BRITTEN: While she is -- while Kellie is 21 getting those up, I’ll just say that I actually am a 22 substitute today, and I want to give full credit to Dr. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 95 1 Patricia Guenther, at the Center for Nutrition Policy 2 and Promotion, who led the effort to develop the 3 Healthy Eating Index 2005 and developed this 4 presentation. She is not able to be at this meeting, 5 so I will try to do justice to Patricia’s work. 6 The Healthy Eating Index 2005, by the way, is 7 called that because it is based on the 2005 Dietary 8 Guidelines, even though it did not come out until a 9 later year. You have heard about the science that 10 underlies the Dietary Guidelines, and a large part of 11 it, for the 2005 Dietary Guidelines, was the DRI 12 Reports. And, what we are looking at with the HEI is 13 going from that underlying science to assessing the 14 Guidelines. And so, you have seen this; you have seen 15 that the Dietary Guidelines Advisory Committee Report 16 was based, among other literature, on the DRIs. The 17 policy document was based on that. And then, My 18 Pyramid developed quantitative information about what 19 and how much to eat based on the Dietary Guidelines and 20 also the DRI Reports. The assessment tool to determine 21 how well Americans are following the quantitative 22 recommendations in the Guidelines and in the My Pyramid Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 96 1 food intake patterns is the HEI 2005. I am going to 2 summarize briefly today the components of the HEI 2005; 3 the scoring system; and the results we have to date. 4 And this is because this is new and it’s very different 5 from the previous HEI. And further details are coming 6 out this month in the Journal of the American Dietetic 7 Association; the full report on the development of the 8 HEI 2005. 9 There are 12 components to the HEI. Nine address 10 adequacy and three address moderation; and the adequacy 11 ones are almost all based on food groups, but some are 12 separated into various subgroups because the Guidelines 13 made statements about subgroups; so that, for example, 14 there is a total fruit component; there is also a whole 15 fruit, and whole fruit is defined as everything except 16 fruit juice. For the vegetables, there is a total 17 vegetables. There is also the most underconsumed 18 subgroups as a separate component, which is the dark 19 green, orange and legumes. The same for grains, where 20 we have total grains and whole grains, because the 21 Guidelines say make half your grains whole. Then, the 22 other adequacy components are the milk, yogurt, cheese Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 97 1 group; the meat and beans group; and oils, which are 2 considered part of -- essential for a diet, but are not 3 deemed a food group themselves. 4 The moderation components, where we have 5 quantitative information, saturated fat, sodium and 6 calories from solid fats, alcohol and added sugar, and 7 I’m going to talk a little bit more about that one 8 later, because that one is brand new. But, we use the 9 term SOFAAS for that, because it’s too much of a 10 mouthful to say, so we talk about calories from SOFAAS. 11 What’s really new about HEI 2005 is that it truly 12 attempts to measure the quality of the diet or the mix 13 of foods, and it does it this by using a density 14 approach. That is, it expresses the standards or the 15 recommendations on the per thousand calorie or as a 16 percent of calorie basis, and it allows a single index 17 to be used for the entire population. So, as a measure 18 of diet quality, it specifically does not assess energy 19 balance or physical activity. And, as you just heard 20 from Cliff Johnson, there are other really good 21 measures of both long-term energy balance, would be 22 measuring body mass index or other anthrometric Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 98 1 measures, and also measures of physical activity. 2 I want to explain the scoring system just a bit. 3 The scoring system, since it’s based on a density 4 function, could be consistent across all recommended 5 energy intake levels. And this is an example showing 6 across the 12 different energy intake levels within the 7 My Pyramid Food Guidance System how much total grain is 8 recommended on a per thousand calorie basis. And so, 9 as you see, there is a slight variation, but not a lot. 10 And, the lowest level of any of these was set as the 11 standard for the HEI, and therefore, on per thousand 12 calorie basis, the standard recommendation for total 13 grain intake would be three ounce equivalents per 14 thousand calories. We used a similar approach for all 15 the adequacy nutrients. For those adequacy nutrient 16 components, the maximum points were assigned for diets 17 that met these standards that are based on My Pyramid. 18 If the person ate nothing from that group, they got 19 zero points. For the moderation components, there are 20 science standards for setting the maximum points that 21 are assigned, but there is no natural zero, and so, 22 zero points were assigned at approximately the 85 Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 99 1 percentile of all intake. Here is how this happened, 2 for scoring the saturated fat component. This is the 3 distribution of saturated fat intakes. Oh, and by the 4 way, all the data that I am presenting here all comes 5 from NHANES, and was used in the development and in the 6 results that I will present today. It’s all NHANES 7 data. So this is, as a percent of calories, saturated 8 fat intakes. 9 The Dietary Guidelines recommend less than 10 10 percent of calories from saturated fat; however, there 11 is also the suggestion in both the Dietary Guidelines 12 and in the Dietary Reference Intake that less is 13 better. Therefore, the 10 percent level was set at, to 14 get a score of eight, not 10. The score of 10, which 15 is the highest score, was set at seven percent of 16 calories, and this seven percent standard dovetails 17 nicely with many science recommendations, such as the 18 American Heart Association; the recommendation in the 19 DASH eating pattern; and is also, when you look at how 20 much comes -- how much saturated fat there actually is 21 in the food intake patterns from My Pyramid, it’s 22 between seven and eight percent. As I said, the zero Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 100 1 score was set at approximately the 85 percentile, and 2 in this case it was 15 percent of calories. 3 Similar scoring for sodium, where this is the 4 intake distribution of sodium per thousand calories, by 5 the way, the intake per thousand calories. The 6 adequacy level or the -- I’m sorry -- the -- this is 7 when I get in trouble doing someone else’s presentation 8 -- the adequate intakes set by the DRI is a basis for 9 the maximum score, and note that for sodium only two- 10 and-a-half percent of these one-day intakes are at that 11 level or lower. The Dietary Guidelines’ recommendation 12 was it to be less than the upper, the UL, the upper 13 limit, and that is 2,300 milligrams, and this is again 14 converted to a density score. And finally, the minimum 15 score, which would be zero, was set at 2,000 milligrams 16 per thousand calories based on the 85 percentile of the 17 intake distribution. 18 Now I’m going to talk a little bit more about this 19 new concept of calories from SOFAAS. The 2005 Dietary 20 Guidelines Committee created the concept of 21 discretionary calories, which was the difference 22 between total energy requirements and energy consumed Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 101 1 to meet recommended nutrient intakes. Discretionary 2 calories can include all solid fats that are consumed, 3 alcohol and added sugars; however, discretionary 4 calories are not specifically those items. They could 5 be amounts of other foods that are eaten in excess of 6 your needs, so that if your grain intake was in excess 7 of the recommendations, those would be considered 8 discretionary as well. However, in practice, while 9 it’s a great concept, it’s difficult to operationalize 10 and measure, and so we needed a component that would 11 address over-consumption. Through a lot of work with a 12 large group of members on a working group, the proxy 13 measure of calories from SOFAAS was created. This 14 represents a subset of all discretionary calories, but 15 the analysis suggests that this is a substantial 16 portion of all discretionary calories. And also 17 important, these components -- these food items, the 18 solid fats, added sugars and alcohol, capture the 19 calories that carry the fewest nutrients in the diets. 20 Both the Institute of Medicine DRI Reports and the 21 Dietary Guidelines point out that recommendations are 22 to be met over time, over the long time; therefore, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 102 1 usual intakes should be assessed. When only one or two 2 days of data are available, as in the case in NHANES, 3 and individual’s usual intake cannot be determined, 4 because of the large day-to-day variation. However, 5 the usual intake of a group can be estimated. 6 HEI scores are calculated for a group’s usual 7 intake by applying the scoring system to the population 8 mean intake, rather than to the individual level 9 intakes. So to determine group mean intake, via the 10 population ratio method, which is shown here. The 11 weighted sum of the population’s total intake for, of a 12 food group, for example, is divided by the weighted sum 13 of the population’s energy intake. And the scoring 14 system is then applied at the group level, not at the 15 individual level. 16 Now to the results. This chart summaries HEI 17 adequacy components for the 2003-2004 NHANES, and these 18 are shown to normalize them as a percent of the maximum 19 score. As you can see, the total grain’s intake and 20 the meat and beans intake meet the recommended intake 21 standards. They are at 100 percent. All the other 22 adequacy components fall far short. Fruit and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 103 1 vegetable intakes are insufficient, and the choices 2 made within the groups are not in accordance with 3 recommendations. If you notice, intake of dark green 4 and orange vegetables and legumes, and of whole grains 5 are strikingly low, if you look at the percent of the 6 total score represented there. These are the three 7 moderation components, and they are presented on the 8 same scale; 100 percent would meet for that, meet the 9 maximum score for that. And, of course, with these, a 10 higher score means a lower intake; or conversely, a 11 lower score means a higher intake of these moderation 12 components. The sodium and saturated fat intakes are 13 too high, and calories from SOFAAS are excessive. Note 14 that most of these calories are derived from solid fats 15 and added sugars in about equal proportion with less of 16 them coming from alcohol. 17 So here is the overall picture of all 12 of the 18 components, and you can see that dietary quality is far 19 from the recommendations of the Dietary Guidelines. 20 The total HEI 2005 score for 2003-2004 is 57.5 percent, 21 an indication that there is much room for improvement 22 in the diet quality of Americans. Thank you. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 104 1 DR. VAN HORN: As per the charge to the Committee 2 outlined by Secretary Leavitt, our task is to determine 3 if revisions to the 2005 edition of the Dietary 4 Guidelines for Americans are warranted based on the 5 preponderance of the scientific and medical knowledge 6 currently available. If the Committee decides that 7 changes are warranted, we will make and submit our 8 technical recommendations and the rationale for these 9 recommendations in an advisory report to the 10 Secretaries between April and May of 2020. To 11 accomplish this task, the Staff has suggested a 12 timeline and milestones, which you can find in tab #1 13 of your notebook. Bear with me a moment. 14 Over the course of our deliberations, we are to 15 gather information, work with federal staff and the 16 Nutrition Evidence Library, to review the science and 17 write our scientific conclusions and recommendations. 18 Over the first few months of our work, we will begin by 19 gathering information, reviewing the evidence base, and 20 identifying topic areas and outside experts with the 21 presentations that can fill our major needs for 22 information. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 105 1 For the first meeting our milestones include: 2 deciding whether we need to proceed with a review of 3 the science, and if so, finalizing our plans with the 4 evidence-based review; initiating plans for potential 5 review questions that are priorities; and determining 6 the scientific areas for the subcommittees that are 7 needed and who will serve on these subcommittees. 8 After this meeting and before the second meeting, 9 subcommittees will begin to work via conference calls, 10 to begin their evidence-based review of the literature. 11 For our second meeting, it is targeted I think now 12 for January, I believe, or February. We will, I guess, 13 vote on that. For the first part of this meeting the 14 subcommittee will participate in work sessions and then 15 bring our discussions to the public meeting of the full 16 Dietary Guidelines Advisory Committee. We will also 17 hear expert presentations on those topics where we 18 believe that additional input is needed. A technical 19 update on My Pyramid food intake patterns will be 20 presented at a second meeting. Although it is not our 21 task to update the Pyramid, the USDA wants My Pyramid 22 to reflect the 2010 Dietary Guidelines. We will also Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 106 1 hear presentations on new data on unusual intakes of 2 nutrients and food groups, as well as the Physical 3 Activity Guidelines for Americans, which were recently 4 released by HHS. Our milestones for this meeting will 5 be for our subcommittees to develop objectives for 6 their chapters using the rough outline for their 7 section of the report. In January and February, 8 subcommittees will continue to work via conference 9 calls, to continue our evidence-based review of the 10 literature and begin to draft some initial scientific 11 conclusion statements and rationale, to be presented at 12 the public meetings, and to begin building our report. 13 The third meeting will be in March. We will again 14 meet to discuss scientific conclusion statements and 15 rationale, and then from April through June of 2009, we 16 will continue our evidence-based review of literature 17 in developing conclusion statements, recommendations 18 and rationale for our chapters. We will also begin 19 drafting technical recommendations and rationale for 20 the report. 21 The fourth meeting will be in July of 2009. We 22 will continue this process, discussing conclusion Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 107 1 statements and rationales and begin to reach a 2 consensus on conclusions as it is possible. At this 3 point our topic area chapters should be well 4 established and in the process of being refined. From 5 August through October of 2009, we will complete our 6 chapters and our report will begin a semi-final state 7 for our final meeting, which is planned for November of 8 2009. Our report should be almost final at this point. 9 It will be presented, and we will determine any changes 10 that are needed before we vote to sign off on the 11 report. Minor edits could still be made after this 12 sign-off, if needed. 13 In the earlier months of 2010, the science writer 14 and the editor will complete many steps that are 15 required for formatting the content into the document 16 that will be the actual report. This includes several 17 steps, such as 508 compliance that is required for this 18 type of document. If any minor changes were needed, I 19 will sign on behalf of the entire Committee, as the 20 report is final, before it is submitted formally to the 21 Secretaries. The report release is planned to be 22 formally submitted to the Secretary of Agriculture and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 108 1 the Secretary of Health and Human Services between 2 April and May of 2010. Upon the release of the report, 3 our service concludes and the Dietary Guidelines 4 Advisory Committee disbands. Throughout this process, 5 the Dietary Guidelines management team will be 6 supporting the Committee. We also have the services of 7 a science writer -- thank goodness -- who will assist 8 us in creating a cohesive report from the individual 9 chapters we will write. Additional information on 10 staff responsibilities is listed in the notebook, at 11 tab #6. 12 Regarding scientific areas of discussion, we will 13 address two areas of scientific discussion this 14 afternoon, as you know; the role of nutrient adequacy 15 and life cycle needs; as well as the role of fluid and 16 electrolytes in health. Tomorrow we will discuss 17 energy balance, including physical activity and weight 18 management, as well as the role of carbohydrate and 19 fatty acids on health. We will also discuss ethanol 20 and food safety and technology. The goals of these 21 discussions are to begin to review current scientific 22 knowledge relating to nutrition and health, and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 109 1 identifying areas of agreement, as well as areas 2 needing further review and discussion. The focus of 3 discussion will emphasize recent scientific advances 4 over the past four to five years in the context of 5 well-established knowledge. For the last Dietary 6 Guidelines meeting the literature was reviewed through 7 June of 2004. Discussion leaders were asked to prepare 8 a 15-20-minute overview of what they considered to be 9 significant advances in knowledge that should be 10 considered by the full committee. 11 We will now take a break for lunch. The Committee 12 will be meeting in a closed session to address 13 administrative matters. For lunch there is a cafeteria 14 on the floor that is open on the public. Exit the 15 auditorium, go to the right. The cafeteria is between 16 wings 2 and 3. Please be sure to keep your visitor 17 badges on at all times while in the building, and if 18 you leave the building, you will need to leave your 19 badge with the security exit and retrieve at re-entry. 20 Please use the security exit and entrance at wing 7, 21 and we’ll reconvene at 1:15. Have a nice lunch. 22 (Whereupon, at 11:36 a.m., a lunch recess is Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 110 1 taken). 2 DR. VAN HORN: We’d like to get started. So, if 3 everyone could please take their seats? Welcome back. 4 We are happy to get started with this afternoon’s 5 session, and to preface our discussions of the 6 scientific topic areas, we will first hear about a new 7 tool that is a major advancement for evidence-based 8 review, the Nutrition Evidence Library. We will be 9 using this library in our scientific review work. 10 It is my pleasure to welcome Joan Lyon, from USDA 11 Center for Nutrition Policy and Promotion. Ms. Lyon 12 has been a nutritionist at CNPP for seven years, where 13 she has been instrumental in the development of the 14 Nutrition Evidence Library. She has also worked on 15 both the 2000 and 2005 Dietary Guidelines efforts, and 16 is a retired U.S. Army Lieutenant Colonel, as well as a 17 registered dietitian. Joan. 18 MS. LYON: Thank you. Good afternoon. It’s my 19 pleasure to be here this afternoon to represent the 20 Nutrition Evidence Library team. 21 Developing evidence-based national and nutrition 22 policy requires a systematic review of published Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 111 1 literature on diet and energy balance, to promote 2 health and reduce chronic disease risks. With over two 3 million articles published annually in nearly 4 biomedical journals, it’s important to efficiently 5 identify and evaluate the relevant evidence. My talk 6 this afternoon will present our plan and preparations 7 to support the scientific review aspects of the 8 challenge that you accepted earlier today. Please take 9 a moment to review my agenda. 10 Over the past two decades the processes used to 11 develop federal guidelines have become more consistent 12 and structured. At the same time advances in 13 technology have continued to improve the efficiency of 14 research and communication tools to support this work. 15 In terms of current expectations for dietary guidelines 16 development efforts, one principle has not changed; it 17 is that guidelines should be based on the preponderance 18 of sound scientific evidence, and generally that means 19 peer-reviewed published research. 20 The preferred methodology for establishing 21 clinical practice guidelines is evidence-based 22 systematic review. This approach is also becoming the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 112 1 standard for developing public health guidance. 2 Another expectation was codified in the consolidated 3 Appropriations Act of 2001, which is also known as the 4 Data Quality Act. This law mandates that federal 5 agencies ensure the quality, objectivity, utility and 6 integrity of the information used to form guidance. 7 The final expectation to highlight here is that of 8 leveraging technology, to assist the process of 9 synthesizing and archiving relevant research. 10 We began the preparations to support you, the 2010 11 Dietary Guidelines Advisory Committee; shortly after 12 the 2005 Guidelines were released. This included 13 taking steps to build upon lessons learned from the 14 very successful 2005 Advisory Committee process. 15 We initiated a dialogue with organizations leading 16 in evidence-based medicine in public health. These 17 agencies described the methodologies, technologies and 18 tools that they developed to develop their systematic 19 review processes. As a result, we established a 20 contract with the American Dietetic Association, to 21 develop a robust electronic library portal. We also 22 established an Executive Committee to provide Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 113 1 leadership, and a federal interest group to provide a 2 collaborative forum to help us shape our plan of 3 operations. 4 This graphic you have seen earlier today, or at 5 least one of them, it depicts the major scientific 6 resources available to the 2005 Advisory Committee and 7 your Committee. Both include published research, 8 evidence-based reports, and the Dietary Intake Reports 9 from the Institute of Medicine. As mentioned earlier, 10 most of the DRIs were published prior to the last 11 Advisory Committee effort, and the fluid and 12 electrolytes report was published about halfway through 13 that process. So, although you will have them 14 available to you as a resource, their relevant content 15 will not be new. The new resource that is available 16 for your use is the focus of this presentation. 17 The Nutrition Evidence Library is a web-based 18 system and set of tools to support evidence-based 19 scientific review. It will be used to build portfolios 20 of evidence abstracts and overview worksheets related 21 to your key topic areas and research questions. It 22 provides document sharing, tracking and archiving Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 114 1 capabilities, as well as group communication tools to 2 facilitate your subcommittee work. This system also 3 contains a variety of review and reporting features 4 that you can use to view your subcommittee’s progress. 5 Now I am going to switch and start using our name 6 for the Library, which is N-E-L, NEL. NEL’s primary 7 purpose is to serve as a resource for you, the 2010 8 Dietary Guidelines Advisory Committee. In the future 9 NEL will be used to inform federal nutrition policy and 10 program development; to identify research gaps for 11 scientists; and to provide science-based information 12 for nutrition stakeholders and consumers. And, to our 13 audience today, that includes all of you in industry 14 advocacy research and education. Eventually this tool 15 will be available for your use as well. 16 NEL provides a number of benefits that dovetail 17 nicely with our obligations regarding the Data Quality 18 Act. They include consistency and transparency. NEL 19 provides the methodology to standardize the scientific 20 review process for each topic area and research 21 question, while allowing for the flexibility to address 22 unique aspects of the subcommittee’s work. This system Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 115 1 documents each step in the process, which makes it 2 possible to trace or replicate the review. NEL’s web- 3 based platform will make it an easily accessible 4 resource for policymakers, stakeholders and consumers. 5 The combination of these features provides us a 6 perpetual foundation that will allow us to continue 7 building the body of evidence for future efforts. 8 The administration and staff with a role in NEL 9 operations include an Executive Committee, which 10 consists of appointed government staff. Its role is to 11 provide oversight and to ensure quality control 12 measures are in place. 13 The NEL management team and research librarian are 14 federal staff, who manage the day-to-day NEL 15 operations. They will also work with the Dietary 16 Guidelines management team, to assist your 17 subcommittees in developing and implementing literature 18 search and sort plans, and other duties including the 19 responsibility for training, recruiting and managing 20 evidence abstractors, as well as performing quality 21 checks on the evidence abstracting process. 22 Our evidence abstractors are national service Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 116 1 volunteers. They are non-government researchers and 2 practitioners. All have an advanced degree and five or 3 more years of experience in a field related to 4 nutrition. Their role is to systematically extract 5 information from published research papers to build 6 evidence worksheets. 7 The NEL project teams will work in conjunction 8 with the Dietary Guidelines’ management team staff to 9 support your subcommittees. There will be one team for 10 each subcommittee; the support from our research 11 librarian and three to six evidence abstractors, 12 depending on the demand of the project. 13 Here you see a schematic of our proposed evidence- 14 based review process. I’ll take you quickly through it 15 highlighting responsibilities along the way. Starting 16 at the top left, first your subcommittees will develop 17 and prioritize research questions for your specific 18 areas of interest. The next step below that is to 19 develop your literature search and sort plan for each 20 question. Generally, we expect that your exclusion and 21 inclusion criteria will be fairly consistent for the 22 whole committee, but there may be some unique aspects Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 117 1 depending on the type of question that you are asking. 2 Now moving over to the top right is the NEL 3 librarian, who will conduct the literature searches and 4 sorts. She and our staff will assist you in sorting 5 the literature to identify the relevant body of 6 evidence for each research question. At that point, 7 the individual articles will be assigned to an 8 abstractor, who will prepare the evidence worksheet. I 9 should also mention that the electronic PDF of each 10 individual article will be available to you, the 11 Committee members, to review as well. Those will be on 12 the portal. As the worksheets are completed, NEL 13 project managers will conduct the quality reviews and 14 extract data fields that you have identified to develop 15 evidence overview tables. Portfolios of evidence 16 worksheets and overview tables will be available to 17 support your scientific review, synthesis and 18 deliberation, and this will be for each research 19 question you identify. 20 Now to the audience, once the Committee has 21 submitted its report to the Secretaries, which you 22 heard will be sometime in the spring of 2010, we do Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 118 1 plan to publish the NEL content on-line and make it 2 available, accessible via www.nutrition.gov. All of 3 the components that I have mentioned so far will be 4 available with the exception of the electronic PDFs of 5 all the articles, and this is for copyright purposes. 6 So the complete bibliography of the citations that are 7 used to support each question will be available, and 8 you can use those to acquire the papers on your own. 9 As the Advisory Committee wraps up its work, our 10 plans for expanding NEL include examining literature 11 related to guidelines implementation. Examples are 12 behavior change and successful education strategies and 13 programs. 14 I mentioned that your subcommittees will develop 15 research questions for your areas of interest. In 16 evidence-based review, researchable public health 17 questions commonly follow a PICO or PICO-D format. 18 P is for population or primary problem. The question 19 usually identifies the most important characteristics 20 of the population. An example in this case would be 21 healthy adults. I is intervention, exposure or 22 procedure. What was the population exposed to? In Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 119 1 this case, let’s use whole grains. Notice my barley 2 pin today. C -- or I -- I’m a little confused now -- 3 sorry -- C is comparators, interactions, linkages and 4 effects to be examined. The comparison may be two 5 distinct interventions, or simply the comparison of an 6 outcome with or without the intervention or exposure. 7 Again, in this case, we’ll use whole grains and 8 consumption levels. O is for outcome; what is 9 measured, improved or affected. This may be the 10 specific disease risk, biologic function or other 11 health parameters. If the outcome is an intermediate 12 biomarker, it should be relevant to the risk reduction 13 for the general public, and an example here would be 14 the incidence of Type 2 diabetes. So, an example 15 question would be something like, in healthy adults, 16 what is the association between whole grain consumption 17 and the incidence of Type 2 diabetes? And we have D 18 for design and duration. Some PICO models use the 19 study design and duration as separate components of 20 this formula. For complex questions or groups of 21 subquestions, an analytic flowchart or a concept map 22 could be used to visually present the PICO components Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 120 1 and the relationships or associations being examined. 2 We NEL staff members do have two requests to the 3 Advisory Committee -- of the Advisory Committee; the 4 first is that you prioritize your research questions. 5 We do have limited resources, and so we ask that you 6 identify one to three high priority topics and research 7 questions to focus on initially. The second request is 8 that if you do use an intermediate biomarker, that it 9 should be one that is valid for health promotion or 10 chronic disease reduction in the general public. 11 This slide lists some of NEL’s specific review 12 features that I would like to address in a little bit 13 more detail. The evidence worksheets will provide 14 detailed information on the major findings, methodology 15 and quality of each study abstracted. Overview tables 16 will present key data fields extracted from each 17 worksheet related to a specific research question. 18 These are flexible and can be adapted to include data 19 fields that are unique to the body of evidence that you 20 are examining. Comprehensive bibliographies, I have 21 touched on already. Evidence summaries are one of your 22 tasks. They are brief, narrative overviews that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 121 1 synthesize the major research findings. Your 2 conclusion statements should provide concise answers 3 for research questions, along with your rationale. We 4 also ask that you address the quality and depth of the 5 evidence supporting the conclusion statements. This 6 will be a useful framework or reference to help 7 policymakers, educators and practitioners understand 8 the evidence. 9 My initial description mentioned that NEL provides 10 a variety of tools to help you manage and review your 11 project status for your subcommittees. Those include 12 -- oh, somehow I got ahead one -- oh, no, I didn’t -- 13 this is just an example of a NEL evidence worksheet. 14 It’s only part of it. When you pull it up, once it’s 15 completed, you can see it in PDF form. Normally they 16 are somewhere in the neighborhood of three to six pages 17 long. Okay. 18 This slide lists some of the tools that NEL has to 19 help with committee management. The first is Secure 20 Group Communications. This is similar to e-mail, 21 although the portal will maintain a history and archive 22 the communication and discussion strings, so that you Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 122 1 don’t have them clogging up your e-mail, and you can 2 come onto the system at any time to catch up with the 3 discussion string. The second is document sharing and 4 management software, which ensures that each 5 subcommittee member is reviewing the current copy of 6 whatever the draft is that you are working on at the 7 time. There is also real time document drafting 8 capability, so you can work on a document during a 9 conference call; one person types in the changes; 10 clicks the save; everybody hits the refresh button on 11 their screen; and all of a sudden voila, you are 12 looking at the current copy of the document. 13 And finally, there is a document archiving system 14 that maintains a history of the document, as well as 15 who has edited it, viewed it and downloaded it. 16 And here you see a sample of our, or a screen shot 17 of a project central home page. In this case this is 18 the home page for our NEL abstractor training. 19 In summary, NEL will ensure that your scientific 20 review is documented, transparent and reproducible; 21 that reviewer bias is minimized; that each 22 subcommittee’s approach is standardized; and that your Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 123 1 review process and information is archived for future 2 DGAC and stakeholder use. 3 Thank you, and what are your questions? 4 DR. NELSON: I have a question. I’m not sure this 5 is on, but you can hear me. 6 MS. LYON: Yes. 7 DR. NELSON: So one of the -- when we used -- 8 because we had a search for data set that was put 9 together from the CDC -- 10 MS. LYON: Yes. 11 DR. NELSON: -- one of the big issues, because we 12 could put different -- we could put different search 13 parameters in it, but we were unable to save any of our 14 searches. Will we be able to save in this? Because 15 you know, we would look for just, you know, by gender, 16 but -- and we had, you know, by age, but we could never 17 save any of the searches. 18 MS. LYON: This is organized a little bit 19 differently than that, in that the papers are 20 specifically linked to the research question that you 21 are asking. There is the capability of searching on 22 key data terms, to identify papers on topics that you Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 124 1 may have a question on that were abstracted for another 2 research question. So there is search capability and 3 I’m not sure -- 4 DR. NELSON: And you can save that search? 5 MS. LYON: Well, yes, you could certainly pull off 6 the list of citations and worksheets that are 7 identified and keep those. Any other questions? 8 DR. APPEL: Here. Joan, that’s great. Two 9 questions for you. 10 MS. LYON: Yes. 11 DR. APPEL: The first question, you said, one to 12 three initial; is that one to three total, or one to 13 three initial questions? And then I have a second 14 question. 15 MS. LYON: Well, it depends on the depth and the 16 breadth of the work that’s required to answer the 17 questions that you ask, so it will vary dramatically, 18 we imagine, between subcommittees. And, as you know, 19 last time we asked some over-arching questions and then 20 it ended up that spun off three or four, you know, sub- 21 questions in some cases, and so we envision having sub- 22 project efforts such as that. So, I know that isn’t a Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 125 1 direct answer, but we’ll have to see. 2 DR. APPEL: All right. 3 MS. LYON: We think for sure that we can answer 4 one to three for each, on average, for each 5 subcommittee. Some of your subcommittees may require a 6 lot less work, and so we envision switching around our 7 personnel to better support the need, in terms of work 8 load that your subcommittees have. 9 DR. APPEL: This is the second question, having to 10 do with your quality assessment. 11 MS. LYON: Yes. 12 DR. APPEL: There is a lot of debate about how to 13 do that and whether its, it should be done. Is this a 14 flexible feature of this, because I think the Committee 15 has to decide how much it wants to do; and if yes, you 16 know, how much, you know, what the format is going to 17 be; is it going to be standardized or customized? 18 MS. LYON: Yes, indeed. That -- our system is 19 flexible. Right now what we have is a study design and 20 implementation checklist that goes through some very 21 specific objective questions answering them yes, no, or 22 the paper doesn’t answer the question. So things about Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 126 1 blinding, various parameters, I guess you’d say, 2 related to study design, bias, those sorts of things. 3 At the end of that, we do have the ability to come up 4 with a quality rating for the paper, which you may or 5 may not choose to use. The validity questions 6 themselves answer many of the questions that you would 7 have, or the checklist itself answers many of the 8 questions that you would have regarding the study 9 design. And this is one aspect perhaps that Dr. Nelson 10 can discuss with all of you about the Physical Activity 11 Guidelines, and as I understand it, they did not 12 directly identify the quality for each individual 13 paper, but more the body of evidence -- 14 DR. NELSON: Or the type of study, how many, the 15 design, was is blinded? 16 MS. LYON: Those were parts of your format, of 17 your templates. 18 DR. NELSON: Yeah, they were there. 19 MS. LYON: Yes. 20 DR. NELSON: And in the end, I mean, we really -- 21 the abstractors did an okay job, but in the end it was 22 more, I guess we all ended up reading most the papers Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 127 1 anyway, so. 2 MS. LYON: And I think that’s our expectation 3 here. And really, the worksheets are more to assist 4 you in your deliberations, so you have those key data 5 elements related to the study at your fingertips in 6 either the worksheet or the overview table. 7 DR. PEARSON: I just want to get a better idea of 8 the interaction between the NEL project team during the 9 abstracting process. I mean, my usual experience with 10 this, as a naïve question preparer, is get back 10,000 11 references, which obviously means I have done something 12 wrong. Is there an opportunity for some back and 13 forth, so we can whittle quickly down? Would this be 14 in a conference call, or is this all done by e-mail, or 15 how does the subcommittee interact with the project 16 team? I’m trying to get an idea of that. 17 MS. LYON: Yes. What we envision is that you will 18 develop your research question and then a literature 19 search and sort plan to accommodate that. We will 20 assist you in that effort, and then we have a dedicated 21 research librarian, who will be conducting the 22 searches. She -- actually, we are very, very fortunate Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 128 1 that our research librarian not only has a Master’s in 2 library science, but also a recent Master’s in public 3 health. So, she is very talented and can help with the 4 initial sorts just by title. And then we, the staff, 5 can assist you in doing the secondary sort by abstract, 6 and then in some cases we may need to go to the full 7 paper to determine whether it should be included or 8 excluded. Does that answer your question? 9 DR. PEARSON: Well just -- 10 MS. LYON: And this would all be with conference 11 calls, and also the system itself has the ability to 12 have a dialogue back and forth in an e-mail sort of 13 tool. 14 DR. PEARSON: Yeah. I’m just sort of seeing a lot 15 of iteration in front so you don’t end up with one of 16 these massive searches that takes you, that you really 17 -- it was really because you really hadn’t honed down 18 initially what -- 19 MS. LYON: The question, you mean? 20 DR. NELSON: I tell you where the Dietary 21 Guidelines -- the bigger problem was things that were 22 missing. It was too -- it was too narrow, so we ended Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 129 1 up having to expand it. 2 DR. VAN HORN: Could -- we are also being asked to 3 state our name before we speak, so the transcriptionist 4 can tell who is talking. Thank you. Sorry. Go ahead. 5 MS. LYON: This is definitely an iterative 6 process. We also envision using completed published 7 systematic reviews to help us with hand searches, if 8 necessary, on certain topics. And so, you know, 9 working as a group with all of your minds together and 10 ours, we should be able to identify the majority of the 11 papers relative to the topic, and this is where the 12 audience comes in. They are all interested in these 13 topics as well, and if they think that you are missing 14 something, be assured, they will let you know. Right? 15 Are you awake out there? Any other questions? 16 DR. VAN HORN: Naomi? Oh, sorry. 17 MR. CLEMENS: Roger Clemens. Many of us have 18 extensive libraries already built in. Can we share 19 those libraries with your team, so that everyone has 20 access to that information? 21 MS. LYON: Yes, you can share the libraries with 22 the team, but because we want this system to be, or the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 130 1 process to be transparent and reproducible, what we 2 need to do is conduct the searches using the search 3 terms that are identified. If there are new search 4 terms, a good example is, the last time around those of 5 us who were involved with carbohydrates and fiber had 6 been conducting searches, and somewhere along the way 7 we realized, well we hadn’t done anything with pulses, 8 you know? In the U.S., we don’t think about pulses. 9 But the U.K. talks about beans and fiber and 10 carbohydrates, as pulses, and so we had to then do 11 another search to look at that particular search term. 12 So we will be doing those sorts of things. And if 13 there are papers that you have that we don’t identify 14 in our process, then certainly we can add that in as a 15 hand search, and it would be identified as such in the 16 list of citations that we include. 17 DR. VAN HORN: Naomi? 18 DR. FUKAGAWA: Naomi Fukagawa. So ultimately 19 though the responsibility for assuring the quality of 20 whatever literature you pull up will fall to the 21 subcommittee members, is that true? 22 MS. LYON: Yes, indeed it does. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 131 1 DR. FUKAGAWA: Okay. 2 MS. LYON: We are here to support you. 3 DR. FUKAGAWA: But you will also have available to 4 us all the ones that you originally skimmed off and 5 brought forth? 6 MS. LYON: Yes. Yes. We will be keeping up the 7 initial sorts. At this point we have not planned to 8 put that initial citation list of, you know, depending 9 on the question, as Dr. Pearson said, there may be a 10 thousand papers, particularly depending on the search 11 terms that you use, and off the top you may be able to 12 eliminate 500 as just not being relevant. So we will 13 maintain that list, but what we are thinking right now 14 is just to keep that as a word document that we have it 15 in the federal agencies at HHS and CNPP, and you know 16 we can make those available to the public should they 17 need them in the future. But we are not planning to 18 post those lists; only the initial sorts. 19 DR. VAN HORN: Other questions from the group? 20 MS. LYON: We will be providing more training for 21 all of you on this system, so this is just a brief 22 overview today, to get you started. Thank you very Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 132 1 much. 2 DR. VAN HORN: With that, I think we are ready to 3 launch now into our topic area of discussions, and 4 we’ll be starting off with nutrient adequacy, and that 5 group is chaired by Dr. Nichols-Richardson, and also 6 includes Drs. Fukagawa, Achterberg, Slavin and Nelson. 7 So, I am not sure how you want to organize your group, 8 but the floor is yours. 9 DR. NICHOLS-RICHARDSON: Okay. Thank you, Madam 10 Chairman and Madam Vice Chairman. Thank you for this 11 opportunity to talk a little about nutrient adequacy, 12 and in preparing for the first meeting, the 2005 13 Dietary Guidelines for Americans were reviewed, and it 14 was found that several issues remained relevant in the 15 area of nutrient adequacy or adequate nutrients within 16 calorie needs. Specifically, overweight, obesity, 17 hypertension, hyperlipidemia, cancer and osteoporosis, 18 among other chronic diseases, continue to be major 19 public health concerns, many of which have clear links 20 to overall caloric intake, dietary patterns and 21 specific macronutrients and micronutrients. Although 22 some progress has been made in promoting healthy eating Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 133 1 patterns, several nutrients continue to be shortfall 2 nutrients, while others are regarded as abundance 3 nutrients; meaning that they were in excess of their 4 recommendations. 5 The United States Department of Agriculture Food 6 and Nutrition Report #FSP08NH, titled Diet Quality of 7 Americans by Food Stamp Participation Status, data from 8 the National Health and Nutrition Examination Survey 9 1999-2004, which was prepared by Nancy Cole and Mary 10 Kay Fox and published in July 2008, documented that 30 11 percent of adults not participating in the food stamp 12 program or the SNAP program and 39 percent of adults 13 participating in the food stamp program had inadequate 14 typical daily intake of vitamin C. About 45 percent of 15 adults consumed less than the estimated average 16 requirement for vitamin A; 66 percent of adults 17 consumed magnesium at a level less than the EAR; with 18 90 percent having vitamin E intakes less than the EAR. 19 For those nutrients with adequate intakes, average 20 usually daily intake of calcium was 88 percent of the 21 AI for all adults and 62 percent of the AI for older 22 adults. Mean intake of potassium was 58 percent of the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 134 1 adequate intake, and fiber was 53 percent of the 2 adequate intake for all age groups. 3 Sodium intake consistently exceeded the tolerable 4 upper intake level or the UL for 90 percent of the 5 population, and as in the 2005 Dietary Guidelines 6 Report that reflected nutrient consumption data from 7 the continuing survey of food intake by individuals 8 1994-1996, shortfall nutrients for adults continue to 9 include calcium, potassium, fiber, magnesium and 10 vitamins A, C and E. 11 The SNAP Program Report also confirmed that nearly 12 37 percent of adults consumed an abundance of energy 13 from total dietary fat, with 60 percent of adults 14 consuming excess energy from saturated fat. 15 Approximately 38 percent of total energy was consumed 16 as solid fats, alcoholic beverages and added sugars, or 17 SoFAAS. And using food intake to evaluate diet 18 quality, the average Healthy Eating Index 2005 score 19 for adults participating in the food stamp program was 20 a 51, and you know that the maximum score is 100. For 21 income-eligible, but non-participating food stamp 22 program adults, the HEI 2005 score was 57, and for Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 135 1 higher income, non-food stamp participants, the HEI 2 2005 score was 59. Older adults fared somewhat better 3 with scores of 63, 68 and 69 in those same respective 4 groups. Healthy Eating Index 2005 areas of concern 5 included a shortfall in total fruit, whole fruit, total 6 vegetables, dark green and orange vegetables and 7 legumes, whole grains and milk intakes, with an 8 abundance of sodium intake and discretionary calories 9 from SoFAAS. 10 Based on the USDA Food and Nutrition Service 11 Report Number CN08NH, titled Diet Quality of American 12 School Age Children by school lunch program -- or 13 excuse me -- school lunch participation status; data 14 from the National Health and Nutrition Examination 15 Survey 1999-2004, again prepared by Nancy Cole and Mary 16 Kay Fox, and also published in July of 2008, the 17 shortfall nutrients for children, most notably older 18 children, included vitamins C, A and E; phosphorous and 19 magnesium, based on comparisons to the EARs. 20 For teenage girls, shortfall nutrients also 21 included Pyridoxine, Folate, Zinc and Iron, and based 22 on a comparison to the adequate intakes, dietary Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 136 1 calcium was a shortfall nutrient for children ages nine 2 to 18 years, but not five to eight years. Average 3 potassium and fiber intakes were below the AI for all 4 children, and mean sodium consumption was abundant for 5 all age groups. About 25 percent of school age 6 children had an abundance of total energy from dietary 7 fat, with 85 percent having an abundance of total 8 energy from saturated fat. Approximately 39 percent of 9 average total daily energy intake was comprised of 10 SoFAAS. For all school age children the mean HEI 2005 11 score was 55 -- again, out of 100. Shortfall component 12 scores, those that were less than 80 percent of the 13 maximum score, included total fruit, whole fruit, total 14 vegetables, dark green and orange vegetables and 15 legumes and whole grains, with an abundance of sodium 16 and discretionary calories from SoFAAS. 17 So, in summary, shortfall nutrients for school age 18 children continue to include calcium, potassium, fiber, 19 magnesium and vitamin E, with vitamins A and C and 20 phosphorous of potential concern for school age 21 children. 22 Some special nutrient needs should be considered Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 137 1 for teenage girls. Abundance nutrients include sodium 2 and SoFAAS. It’s important to note that these reports 3 were silent for vitamin D and there are various reasons 4 for this, and Dr. Miriam Nelson will address this 5 nutrient in a few moments. 6 Median recommended intakes for these nutrients 7 within the acceptable macronutrient distribution 8 ranges, or the AMDRs, and total energy allowance will 9 require emphasis of a variety of nutrient-dense foods 10 in the 2010 Dietary Guidelines. Healthy Eating Index 11 2005 data from aforementioned reports indicate that 12 selection of healthy foods needs attention, and Dr. 13 Joanne Slavin will touch on the area of whole foods, 14 but I do want to interject that nutrition and dietetics 15 professionals, extension agents and specialists are 16 keenly interested in promoting whole foods and dietary 17 approaches to healthy eating that incorporate foods 18 that are environmentally friendly and economically 19 friendly. 20 At the 2008 Food and Nutrition Conference and Expo 21 held by the American Dietetic Association earlier this 22 week approximately seven educational session, one Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 138 1 excursion and one entire dietetics practice group 2 focused on healthy eating through local foods, 3 sustainable diets, a green environment and economics of 4 food. 5 The American Association of Family Consumer 6 Science’s theme for their 2009 Annual Conference is 7 sustainability, and will include educational sessions 8 for professionals on the integration of food, financial 9 literacy and near and far environments. The 2010 10 Dietary Guidelines should consider food sustainability 11 and economics when possible. Consideration in this 12 area includes food fortification, biotechnology and 13 nanotechnology and their implications for nutrient 14 adequacy and toxicity and environmental sustainability. 15 Culturally sensitive food patterns that may or may 16 not include vegetarian choices, milk and milk product 17 substitutions and other contextually relevant eating 18 approaches require examination due to the fact that the 19 demographic profile of the United States has changed, 20 and will continue to have increases in African- 21 American, Hispanic and Asian populations. 22 The AMDR for dietary protein is five to 20 percent Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 139 1 of total energy for children, aged one to three years; 2 10 to 30 percent of total energy for children, aged 3 four to 18 years; and 10 to 35 percent of total energy 4 for adults, aged 18+ years. Data from the National 5 Health and Nutrition Examination Survey 1999-2004 6 indicate that children and adults consume average daily 7 intakes of dietary protein that fall within the AMDR 8 for each age group. Most dietary patterns focus on 15 9 percent of total energy from dietary protein; however, 10 this macronutrient has received considerable attention 11 in the past five years in several areas, including 12 usefulness of high, meaning the 20 to 35 percent of 13 total energy protein intake range, and dietary 14 approaches to weight maintenance; satiety; prevention 15 of sarcopenia and osteoporosis; risks for osteoporosis 16 and renal stones and plant-based dietary proteins as an 17 approach for healthy eating. Data are somewhat 18 conflicting in each of these areas; thus, dietary 19 protein requires a full evidence-based review of its 20 relation to health promotion and disease prevention 21 prior to specific incorporation into the 2010 Dietary 22 Guidelines. Some research questions include, what is Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 140 1 the role of high dietary protein, meaning that 20 to 35 2 percent range of total energy and weight management; 3 what is the effect of high dietary protein on satiety; 4 what are the effects of high dietary protein on 5 specific disease processes; and can recommended 6 micronutrient intake be met with a plant-based protein 7 diet pattern? 8 So, Dr. Naomi Fukagawa will mention red meats as a 9 source of protein and other important nutrients, and at 10 this time, Dr. Fukagawa will comment in the area of 11 nutrient adequacy. 12 DR. FUKAGAWA: Thank you, Shelly. I hope it’s all 13 right for us to be a little informal that way? 14 DR. VAN HORN: It is. 15 DR. FUKAGAWA: So my comments will largely focus 16 on the macronutrient protein in two different areas, 17 and my comments really are not related to the percent 18 of calories that are coming from protein, but really 19 more towards the amount and source of dietary protein. 20 So, in that area, I thought there were three questions 21 that we may want to consider through this Committee. 22 And, as many of you know, in the 2005 Dietary Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 141 1 Guidelines, there was very little change in the actual 2 recommendations for what dietary protein intakes should 3 be, but data about the needs of older individuals I 4 think still remain somewhat controversial since old is 5 considered 18+. And I think we all would agree that we 6 do change as the chronological years move on. So 7 therefore I do think that one area we need to revisit 8 is the evidence that, to question whether or not we 9 need to revisit the “requirement of older individuals”, 10 especially in the context of chronic diseases, of 11 disease prevention, and/or just purely maintaining 12 general good health of the population. 13 So then moving beyond protein requirements, a lot 14 of epidemiological data has raised the concern about 15 the possible relationship between red meat and cancer 16 and certain forms of protein and hypertension and 17 cardiovascular disease; while at the same time, as we 18 all know, all protein diets were being promoted and 19 used for a lot of weight loss regimens in the past five 20 years, and there were also mixed reviews about how 21 compliant the population had been in adopting the 22 recommendation that we perhaps shift towards more Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 142 1 plant-based proteins in our diets and to try to 2 minimize the amount that was coming from animal 3 proteins. 4 So, as I mentioned earlier, I do think that there 5 were a lot of changes that occur with protein 6 requirements over the life span, which is influenced 7 over chronic disease. But one question that I think we 8 should also address would be number two on my slide, is 9 are we willing to discourage the consumption of red 10 meat knowing that it’s also a source of other 11 nutrients? And I believe Cheryl will address that, 12 along the lines of that, and as well as the intake of 13 whole foods. 14 Finally, I do think that we all know from a 15 scientific basis that a high degree of association in 16 epidemiological studies does not imply causality. So 17 we do need very careful evaluation of the data 18 implicating red meat in disease pathogenesis, and as I 19 said, especially since whole foods may provide an 20 important source of other nutrients. 21 And finally, with respect to our intake of dietary 22 protein, one thing that has obviously become -- that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 143 1 people have become quite aware of is the fact that 2 peptides released from the digestion of dietary 3 proteins by enzymatic proteolysis or protein breakdown 4 have been shown to have bioactivity and can range 5 anywhere from being opiate-like through being anti- 6 thrombotic, anti-microbial, anti-carcinogenic, also 7 demonstrating growth-promoting properties. And so, 8 therefore, I do think it’s very important, in light of 9 the protein intake that we begin to evaluate the value 10 of the bioactive proteins and peptides in our diets. 11 Now we can move to the next slide. So the next 12 area that I wanted to touch on, which does relate to 13 protein metabolism is that of methyl groups, and for 14 those of you who forgot some of the basic biochemistry, 15 a methyl group is a carbon with three hydrogens 16 attached to it. The availability of methyl groups and 17 this particular nutrient group actually transects 18 multiple areas of our subcommittees that we are dealing 19 with today. The dietary protein is certainly a source 20 of the essential amino acid methionine, which is 21 extremely important in methyl donation to various 22 pathways via S-adenosylmethionine or many of you know Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 144 1 it as SAM, because as you know, SAM or SAM-E has been 2 on the health foods markets for quite a number of years 3 to promote health in a variety of different systems. 4 Moreover, I think the vitamins folate and B-12 5 identified as being very important in 2005 and earlier 6 play a key role in methionine and methyl group 7 metabolism, and this also leads to choline, which is 8 also recently identified as a potentially required 9 nutrient is also playing an important role in methyl 10 group metabolism. So you may all be wondering, why in 11 the world are methyl groups so important? Well I think 12 one of the things that’s come -- that we have learned 13 in the last five years, or since the last group of 14 Dietary Guidelines came out, is that methylation of DNA 15 is a known mechanism for gene regulation. And there 16 are recent reports that have linked methyl group 17 availability in the diet with susceptibility, for 18 example, to increased allergies or allergic airway 19 disease. And I think from the standpoint of public 20 health, it is of interest that the prevalence of 21 childhood asthma and other allergic disorders began to 22 increase after the fortification of foods with folate Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 145 1 that began in the late 1990s. And this is not to say 2 that I am -- that folate supplementation is not good 3 for certain populations, but I just thought that it’s 4 timely for us to begin to consider the new data that’s 5 available that shows the complex interaction between 6 specific nutrient groups or specific nutrients and 7 general health. And so this ties in well, and I’ll 8 segue to Dr. Mim Nelson, who will talk about the 9 complex interactions between folate and cancer, as well 10 as other vitamins. 11 DR. NELSON: So, am I next? All right. Oh great. 12 Thank you. Thank you very much. Thank you, Naomi. 13 So, I’m going to talk a little bit about -- and I 14 think what I’m going to bring up is maybe more 15 questions than any answers, at this point in time 16 seeing that I had exactly about an hour-and-a-half to 17 put this together, so. But, I want to look at when we 18 had our initial sort of discussion within our 19 subcommittee about when we look at the 2005 Dietary 20 Guidelines, you know, what seems to be some issues that 21 maybe we should revisit or things that are new based on 22 just new evidence. And so these were two nutrients and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 146 1 which I think are particularly interesting in terms of 2 changes in the evidence. 3 So, the first is sort of defining what I call the 4 dual effect of folate and cancer risks, and I will say 5 just right off the bat that I really want to 6 acknowledge my colleague at Tuft, Joel Mason, who has 7 really been at the forefront of much of this research. 8 He helped me to put these slides together. But, there 9 is definitely -- and I’m sorry I don’t have a pointer 10 -- but, on the -- if there is too little folate we 11 know that there is an increase in cancer risk. But, 12 the question is, if there is too much folate, is there 13 also an increase in cancer risk? And, as everybody is 14 very aware, in 1996, we knew that voluntary 15 fortification of folate in the grain supply began and 16 it became mandatory in 1998. Almost all of the grains 17 were started -- were -- by 1997, were already in the 18 United States fortified at 140 micrograms per 100 grams 19 of flour. In Canada, they were exactly one year later, 20 and I’ll tell you in a minute -- show you some data 21 that are pretty provocative, or at least ask some 22 questions about what we are doing. So, was it Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 147 1 successful in terms of bringing up serum levels of 2 folate? And the top line here is looking at the 3 increases in serum folate levels in Canada and they 4 really doubled. 5 The voluntary fortification began in 1996, but the 6 full fortification was in 1998, and you can see that 7 they pretty much doubled here in the United States. We 8 went from 11.4 nanomoles per liter to 26.9, so this was 9 an incredibly effective fortification in terms of blood 10 levels increasing. But some other things happened 11 along the way, and one would think that this evidence 12 would have been available for the 2005, but really, in 13 terms of looking at the effects of the fortification 14 plan, these data weren’t available until the last 15 couple of years, in which they have been published. 16 And, what we have here is, on the left axis, is 17 colorectal cancer rates per 100,000, and then it goes 18 from 1985 on up to 2002. And you can see that they 19 were slowly going down with better screening, a lot of 20 it going down, and then right when the voluntary 21 fortification and then the mandatory fortification, you 22 can see that there was a bump in rates, and that’s Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 148 1 where fortification came, so there was a real kink in 2 the reduction in colorectal cancer incidents. 3 What I can show here, which is probably the most 4 important, is you can see the voluntary fortification 5 here. This is excess colorectal cancer incidents per 6 100,000 population that we have had a bump and it’s 7 stayed -- it’s about 15 -- in excess of 15,000 excess 8 cancer incidents per year, and it’s remained steady 9 since the fortification went into being. This is in 10 the United States. 11 In Canada, which is great, because we had another 12 natural experiment, it was exactly one year later when 13 all of this happened. And you can see that, back to 14 having curves that are similar, but the excesses are 15 similar number per 100,000. It’s around 3,000 excess 16 actual numbers in Canada. So clearly something is 17 going on. I mean, certainly we don’t know about, you 18 know, associations don’t always mean causality, but 19 something is going on here. I don’t have some data, 20 but there is also some hint at -- and Eric may know 21 more about this -- but also with some breast cancer 22 rates that had followed suit with this as well. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 149 1 Now one might say, is it just because we have 2 better surveillance? And the data here, you can see 3 the four dots. This is from 1993 to 2000. So it 4 covers -- this is looking at endoscopy rates percent. 5 And you can see there was really no excess increase in 6 endoscopy rates. It has been since then, but during 7 the time that these data that I just reported, it 8 wasn’t because we were just uncovering more. So, there 9 continues to be compelling observational experimental 10 evidence the inadequate intakes of folate enhanced the 11 risks of colorectal cancer. But, as Naomi said, there 12 seems to probably -- if there are some harboring 13 cancerous or precancerous cells within the colon or the 14 rectum that abundant folate may actually be 15 accelerating the carcinogenesis. So the use of 16 supplemental folate, whether by voluntary 17 supplementation or mandatory fortification, should be 18 undertaken with careful consideration for the potential 19 risks and benefits of each individual. I think we 20 really need to look closely at this, because it has 21 been a bit of a moving target. 22 Now one thing that is interesting, which I didn’t Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 150 1 know, and that is, where we have to exercise a little 2 bit of caution is it looks at -- and I don’t have the 3 data here -- but it looks as if the food manufacturers, 4 the millers, were quite concerned that they would 5 actually meet the right level, and so probably most of 6 them, it looks like they may have done two or three 7 times as much fortification as was necessary, and 8 that’s actually started to come down a little bit. So 9 it could have been that there really was initially just 10 way to much folate that was -- and we know that neural 11 tube defects have come down, so that’s been beneficial. 12 But there are some other issues, and one other issue 13 which I don’t have slides for as well is there seems to 14 be -- and it was noted in 2005, some issues with B-12. 15 And in the presence of low B-12 with high folate 16 levels, especially with older adults there may be some 17 accelerated dementia. So that’s another issue. So I 18 would say cancers, in general, especially colorectal 19 cancer and breast cancer and potentially dementia, and 20 as Naomi spoke about, potentially maybe some harm with 21 asthma and other respiratory conditions. 22 So, do we need to modify our present system? I Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 151 1 think that’s a big question. Do we need to suggest to 2 adults consuming vitamins, what do we need to suggest 3 to them in terms of vitamin supplements containing 4 folic acid? So, I’d say that’s sort of a question 5 that, at some point, we should address. 6 So now I want to just move right into a totally 7 different nutrient, vitamin D, and the rationale why we 8 may need to want to reconsider -- it was in the 2005, 9 but it was more pushed towards the back, and I think 10 some of that is because we weren’t revisiting the DRIs 11 at the time. Right now we are in the thick of -- I 12 mean, there is a whole committee looking at vitamin D 13 and calcium. And so, I hope we can work in parallel 14 maybe with the IOM Report, because I think it’s going 15 to be important. We can’t ignore vitamin D. 16 So, without going into a lot of detail, there is 17 additional evidence of vitamin D’s benefit on reducing 18 risk of osteoporosis and fractures in older adults; 19 common cancers; type I diabetes; hypertension; and 20 infectious diseases around the immune system, in 21 particular. So, there is more evidence it’s not just 22 bones. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 152 1 These are some data -- there was a very important 2 NIH consensus conference that was in September 2007, 3 and the supplement, American Journal Clinical Nutrition 4 had a full supplement on the proceedings. I have not 5 read every single paper from the supplement. I have 6 sort of pulled out some salient points, but this is 7 looking at different cutoffs. You can see, if you even 8 just look at the left-hand three bars looking at the 9 hatch just below 27.5 nanomoles per liter, the dark 10 black one is under 50 and then the 80, under 80; it 11 looks at the percent by cutoff of individuals. And the 12 consensus now in terms of looking at a lot of the 13 research is that 50 -- there has been a lot of 14 questions about it -- but 50 or above is in the 15 healthier range, and below 50 is where you will 16 definitely be reducing rickets possibly below 50, but 17 it won’t be having the full benefits. By sex, you can 18 see this is looking at the 50 nanomoles per liter 19 cutoff, around 30 to -- 25 to 35 percent of men and 20 women have levels that are below the 50 nanomoles per 21 liter. So we are talking about a third of the 22 population that has suboptimal levels, and certainly we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 153 1 know that people in the north have lower levels than 2 people in the south. 3 I don’t need to go -- this is data from the 4 NHANES. I understand that the newer data will be coming 5 out soon, but this is showing just food intake, in 6 terms of from food and supplements. And you can see, 7 even at -- this is international units per day. I did 8 -- I cut off the children for now. I mean, it’s all 9 pretty similar, but it’s somewhere in the vicinity of 10 200 to 300 international units a day in terms of 11 intake, which is already below what the current DRIs 12 are, which will most likely be doubled or tripled in 13 the next iteration. 14 So some other things to just recognize, and some 15 of this is because the DRIs are done not as frequently, 16 but the American Academy of Pediatrics this month 17 doubled the recommendations for children to 400 18 international units where it has been 200 with the 19 DRIs; National Osteoporosis Foundation in November a 20 year ago increased for adults from 400 to 800 for under 21 age 50; 800 to 1,000 for adults 50 years of age or 22 older; and as I said before, the proceedings from the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 154 1 NIH Conference also had a lot of -- while they didn’t 2 necessarily come out with what the actual 3 recommendations should be, there was a lot of evidence 4 that we have low serum blood levels and we need to be 5 getting more vitamin D. And it’s most likely related 6 to the fact that we really are from a -- 7 anthropologically, from an environmental standpoint, we 8 are getting less sun exposure and there are issues with 9 skin issue, and everybody has gotten that message. 10 They are covering up, putting on sunscreen and staying 11 out of the sun. And then, as I said before, blood 12 levels are low across all age groups, and there is more 13 scientific evidence that there is benefit for numerous 14 health outcomes with higher levels and is currently 15 looked at. 16 So, the only thing I would say here is I do think 17 especially with vitamin D that we need to be -- I would 18 hope at a future meeting we might ask one of the people 19 from the vitamin D IOM Committee to come and present 20 that we help the -- we work to coordinate those 21 efforts. 22 MS. McMURRY: Thank you. I’d just like to just Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 155 1 provide a little more background on the IOM study of 2 vitamin D. 3 DR. NELSON: Yeah. 4 MS. McMURRY: There have been, as you had said, 5 there was attention, a lot of attention in the 2005 6 Dietary Guidelines Committee, and as well as there is 7 an interagency and actually intergovernmental federal 8 steering committee on the DRI project, and we have -- 9 it’s been a very strong topic of discussion for the 10 last couple of years, and as a result, the U.S. and 11 Canadian governments, as you said, have requested the 12 IOM to convene a 14-member scientific committee to 13 devote a concerted, their concerted attention to this 14 very complex topic area. The complexities have to do 15 with the type of scientific evidence available; the 16 intake information available across the board. Also, 17 to support the committee, and in one primary area of 18 support, the Agency for Health Care Research and 19 Quality is conducting an evidence-based review for both 20 vitamin D and calcium. Their report is expected in 21 June of 2009, and that will be presented primarily to 22 the DRI Committee, but certainly we can share that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 156 1 information with you as well. And I just would 2 strongly encourage you to, as you said, try to think of 3 a way to try to be complementary in your efforts, but 4 not duplicative in any way. 5 DR. NELSON: I think that the -- Mim Nelson again 6 -- I think -- I think we need to do that. We would be 7 absolutely delinquent if we don’t deal with vitamin D 8 in this report, because it will be, you know then 9 literally we will be way behind the times. 10 DR. SLAVIN: Oh, thank you. My area of was to 11 follow-up on some of the more of the whole foods, so 12 that’s what I am going to talk about. 13 Diet is really difficult, and that’s the thing 14 with nutrient adequacy; when we chance one nutrient, we 15 tend to lose out on another, so it varies greatly day 16 to day. It’s very difficult to evaluate. And I think 17 the nutrition in the past we have really taken this 18 reductionist approach to diet, because we want to 19 change something and experiment and see if there is an 20 effect of that change. So we might look at calories or 21 macronutrients, micronutrients, which I call really 22 micromanaging the diet. And most of us, despite what Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 157 1 we say, have a real affinity for one nutrient or one 2 area, so it’s hard to look broadly at the whole diet. 3 And that’s -- the goal of our subcommittee is to make 4 sure we are not losing sight of the overall diet and 5 chasing our favorite nutrient. 6 Another area we want to emphasize is just dietary 7 patterns, and this gets into we know that certain 8 dietary patterns are very protective, and we don’t know 9 exactly what nutrient or phytochemical or what 10 combination, so the importance of dietary patterns, 11 intake of whole foods, that people do eat whole foods, 12 and that those things bring different things to the 13 diet. 14 I think eating frequency -- some of the basic 15 things in nutrition, we forget about the snacking. How 16 often people eat get lost in our focus in nutrients. 17 Social aspects of eating -- I have to tell a little 18 story. I went on a sabbatical over in Switzerland. 19 All my students assume it’s just because I like to hike 20 and ski and that’s true too, but supposedly I said I 21 wanted to learn something, and one of the things we had 22 to do where I was is have an hour for lunch. And we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 158 1 actually had to check out during that hour and you had 2 to go and eat for an hour for lunch. And just to -- 3 having lived in this world of never taking time to eat 4 and talking to people, it was real experience of the 5 benefits of taking an hour of lunch and having some 6 fellowship with people. So, just that social aspect of 7 eating we want to make sure that we consider that. 8 I also talk about this idea of making peace with 9 food; that it seems like some much in my dietetics 10 career we have gotten the nutrient or the bad guy of 11 the month, then we just beat him up until we try to 12 kill him, and then we move on to a new enemy. And 13 rather than just seeing that overall food is an 14 important aspect and not completely focusing on one bad 15 guy and then going off in the wrong direction. 16 This is just a little study about food sources and 17 dietary correlates, and only in controlled feeding 18 studies can you hold fat intake constant vary fiber 19 intake. So when you start looking at real diets, 20 things go -- you know, like at the end of the day you 21 are going to eat 100 percent of your calories from 22 either fats, carbohydrates, protein or alcohol, and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 159 1 what’s the perfect combination? If one goes up the 2 other has to go down, so you know, those things are 3 going to change. And once we change one -- if we 4 decide fat has to go really low then something has to 5 go really high to replace that. We know that certain 6 patterns are protective. There is a lot of data. So 7 plant foods, fruits, vegetables -- but, is it the fat 8 or is it the other things in that. And we know that 9 people that eat lower fat, consumers have higher 10 intakes of things that go together with these plant- 11 based diets, so things like dietary fiber, water 12 soluble vitamins, minerals -- and, if we cut down too 13 much on fat, then we lose things; the flavor in the 14 diet and also fat soluble vitamins. So whenever we 15 make a big change -- I think so often people think that 16 committees are kind of not bold; that we don’t do bold 17 things, and being that we are in Washington and it’s 18 political, I think sometimes it’s good not to make huge 19 changes, because there are things in the diet we don’t 20 think about that are really important if we cut out a 21 whole food group. 22 Okay. People eat food not nutrients, and I always Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 160 1 tell my students if it was only nutrients we would all 2 drink infant formula the rest of our lives. Why get 3 off it? You know, we could live -- we know people have 4 lived on liquid diets in nursing homes for 25 years. 5 We know the nutrients. We can keep you alive, but is 6 it really worth it? So, trying to take what we know 7 about nutrients and make sure that we get those 8 nutrients into you, but then consider all the other 9 things that are important about food. And all the 10 surveys show taste, convenience, familiar, not 11 nutrition, typically are the leading factors when 12 people choose food, and when we lose sight of that, all 13 of our nutrition recommendations are ignored because we 14 forget why people do eat. 15 There is no question our number one issue, and it 16 will come over again and again is that we have an 17 obesity problem, and if people aren’t willing to do 18 more exercise and we can’t get that changed much, we 19 are going to have to have them on pretty low calorie 20 diets, and that really brings the importance of 21 nutrient-rich foods to get into the diet. So, fruits, 22 vegetables, grains, legumes, dairy, meat -- so often we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 161 1 get criticized for our dietary guidance systems. 2 People say, why are these foods in your systems? 3 Because these foods provide a lot of nutrients per K- 4 cal. So, if we decide to take any of those out of our 5 nutrient guidance, we have to think of how we are going 6 to get those same nutrients back in without adding 7 calories. 8 I also think just overall food costs have to be 9 considered. As somebody that talks about whole grains 10 a lot, one of the big push backs I always get from 11 people is the cost. I mean, if it’s twice as much for 12 a whole grain, it better be twice as good for me or I’m 13 not going to do it. So, in cost, so often -- we are 14 going to talk more about proteins, the importance of 15 proteins; that’s an expense; fresh fruits and 16 vegetables. It might be great, but if it’s too 17 expensive it’s not going to happen. The same thing 18 with whole grains. So, just making sure our 19 recommendations fit into what people can actually 20 afford. That’s it. That’s where the nutrient adequacy 21 subcommittee is at this point. 22 DR. VAN HORN: Excellent. Are there other Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 162 1 questions or comments from the Committee that -- Larry? 2 DR. APPEL: Yeah. I have a question about the 3 folate discussion. You know, with cancer I always 4 think of a lag period and almost it was too clean, you 5 know, maybe even overlapping with food fortification 6 and the change in the curve, and you know, I think 7 there are probably other, you know, explanations 8 confounders. The one that came to my mind, you know, 9 and you actually dealt with the surveillance, but there 10 was a tremendous interest in folic acid supplements in 11 the 1990s. I can’t tell you when it started, but I 12 suspect it might have even before the food 13 fortification. I guess I’m a bit skeptical when you 14 see a food fortification and then incidence rate at the 15 same time almost overlapping. 16 DR. NELSON: Well, I think -- this is Mim Nelson 17 -- I actually -- I talked at length with Joel Mason 18 about that exact question, and a couple of things that 19 are interesting is, one is, when you look at the U.S. 20 levels of folic going up and the Canadian, they track 21 really well when the fortification happened. Because 22 there have been a lot of other -- plus, like people Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 163 1 started taking a lot. Unless people started taking a 2 lot more supplements at exactly the same time, the 3 increases in blood levels tracked really well with the 4 fortification. So that’s one thing that’s interesting. 5 The prevailing hypothesis, at least with 6 colorectal cancer and potentially with breast cancer, 7 is that these are -- that there are already polyps in 8 the colon that are precancerous, and that what happened 9 was -- and this is at least with animal data, this is 10 the way it works -- when you give a high level of 11 folate and there are polyps, it stimulates the polyps 12 to grow and to become cancerous. So, where the cancer 13 protection has been has been with people not with 14 polyps already in their colon. So, I don’t presume to 15 be the national expert in this, but the hypothesis is 16 that it’s what it did. Because if you look at -- then 17 the lip rates go back down again, is that it kick- 18 started those individuals who had precancerous polyps. 19 That’s the prevailing hypothesis, so. 20 DR. PEARSON: This is Tom Pearson. I’d like to 21 continue this folate discussion, just a couple points. 22 Number one is, is that the ecologic data that you have Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 164 1 showed I think is very provocative. On the other hand, 2 there are randomized controlled trials of folate, 3 usually particularly in the homocystine and stroke 4 prevention area, which would be a lot less 5 indecisiveness, and probably on an evidence base would 6 hold the answer, particularly compared to the -- if you 7 work with the timeframes you are talking about. So, so 8 the -- 9 DR. NELSON: There are three other -- there are 10 three randomized controlled trials that do show an 11 increased incident with colorectal cancer. One was 12 there was another arm with aspirin, but -- and they all 13 show similar increases and they were large enough 14 trials with people who had precancerous polyps, but 15 were not -- 16 DR. PEARSON: Statistically significant? 17 DR. NELSON: Yeah. Yeah. But they were -- they 18 were a chosen group that had the polyps to begin with. 19 DR. PEARSON: The polyps? Yeah, I was thinking 20 more of some of the stroke prevention trials with 21 people with homocystine elevations, which would be a 22 much more. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 165 1 DR. NELSON: Yeah. 2 DR. PEARSON: The other -- the other request, as 3 you go into this, one would hope that one didn’t get 4 into a competition between the food supplementation and 5 -- for the prevention of birth defects versus some of 6 these issues in the elderly. 7 DR. NELSON: Yeah. 8 DR. PEARSON: If you -- 9 DR. NELSON: Well, the colorectal cancer is just 10 elderly, so. 11 DR. PEARSON: Well, just let me continue. 12 DR. NELSON: Yeah. 13 DR. PEARSON: The discussion there would obviously 14 be me talking about some issues in the elderly with 15 perhaps more than one cancer. You would really need a 16 health economist to then equate that to the prevention 17 of a lifelong disability in a youngster. You know 18 birth defects, as you know, is one of the more 19 common -- 20 DR. NELSON: Right. Right. 21 DR. PEARSON: -- or at least it used to be one of 22 the more common defects leading to disability, years of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 166 1 life lost of considerable number. The other point to 2 be made there, and the Canadian data is superior to the 3 U.S. -- it’s the same data set that you showed -- is 4 obviously the prevention of a number of other 5 congenital defects, among them, cardiac. 6 DR. NELSON: Yes. 7 DR. PEARSON: And they have shown, I think a 8 decrease in congenital heart disease at the same time. 9 So, if you are going to have an equation amounting up 10 the number of tumors on one side, you are going to have 11 an equation saving a number of congenitals, and that’s 12 going to be a very tricky balancing, unless you can 13 come up with a strategy in which to supplement in 14 child-bearing aged women and not in elderly. The folic 15 supplementation efforts using pills of folate, which 16 was occurring based on liptimology clinical trials 17 before I don’t think was successful, particularly in 18 the highest risk groups, which would be your low income 19 groups, in which they are simply not going to be doing 20 that. So that was the public health -- so, I think 21 this is a conundrum that might be sort of outable in a 22 health economics sense. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 167 1 DR. FUKAGAWA: I just -- this is Naomi Fukagawa. 2 I just wanted to comment on the question about homocyst 3 -- hyperhomocystinemia and cardiovascular stroke. You 4 know folate certainly has reduced the prevalence of 5 hyperhomocystinemia, but I think that the general 6 feeling now is that hyperhomocystinemia is really a 7 marker of the disease pathogenesis and not causal. So, 8 therefore, I think even if we have made improvements, 9 and I’m not being pro or con folate supplementation or 10 removing it, I just think that there is a lot of new 11 information on the block that would be very important 12 for us to consider as to whether or not we continued to 13 fortify at the rates that we are fortifying, or whether 14 or not it should be self selection. And no doubt that 15 the reduction neuro tube defects is a worthy cause and 16 reason to continue, but I am just bringing up these 17 other questions that are occurring; and the question 18 that I brought or the issue I raised with respect to 19 the methylation of DNA is that this is something -- 20 granted it was done in animal studies, but it does 21 appear that these are epigenetic changes that are 22 occurring in DNA which does get passed on to the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 168 1 progeny. So, therefore, we are potentially impacting 2 future vulnerability of the population. So that’s my 3 reason for bringing it up as a consideration. 4 DR. APPEL: This is a more general question. You 5 have a huge number of nutrients on your plate, you know 6 -- and no pun intended -- but there is -- you know, so 7 -- you know, I’ll just throw out one. You didn’t talk 8 selenium, and you know there was a trial was stopped 9 recently, and part of the reason they stopped it was 10 they saw adverse trends in diabetes, and there is 11 actually a literature on selenium within actually, not 12 supplemental levels, but dietary levels where it could 13 be bad. So, are you going to sort of -- I’m not sort 14 of picking on selenium, but are you going to just go 15 through every one of these and just say, you know, 16 should we, you know, do it? Is this one of our 17 questions, or how are we going to approach this, 18 because I am worried a little bit about cherry picking. 19 DR. NELSON: Well, I can just say, to prepare for 20 this meeting, we didn’t have a lot of time, as you very 21 much know. 22 DR. APPEL: Yeah. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 169 1 DR. NELSON: And I think what we were sort of 2 looking at was where are some sort of big questions 3 that -- I mean, I agree with you completely, that we 4 need -- there needs to be a good look at the risk 5 benefit ratio and everything else with folate, but I 6 hope -- I mean, I think one of our charges with our 7 subcommittee is that we really will do a little bit of 8 a systematic -- maybe not have a million questions for 9 the NEL group, but we will do a systematic look at all 10 the nutrients and then choose the ones that, where the 11 evidence since 2004 is warranted a good evidence-based 12 review. That’s what I would hope we do. 13 DR. NICHOLS-RICHARDSON: It’s Sharon Nichols- 14 Richardson. I would just add to that that I think part 15 of just preparing for this meeting was to take a look 16 at the 2005 Dietary Guidelines and then to look at the 17 best information that we had, and those were the 18 reports that came out from NHANES data. Part of I 19 think the issue of looking at the nutrient intake is 20 that the database for nutrients within foods, that some 21 nutrients are not as well characterized in foods as 22 others, and so what we have when we look at the NHANES Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 170 1 data and other data is that we have our best knowledge 2 that we have about what is contained within foods. So, 3 while selenium would be great, and part of the issue 4 with vitamin D is that some of the databases that we 5 did the comparison is just not perfect, so. 6 DR. NELSON: But -- yeah -- I have another 7 question that sort of similar to that, and that is -- 8 and this might be for the Beltsville Research Center, 9 but is there any evidence -- I just ask the question. 10 I don’t have the answer to this. Is there any evidence 11 that in fact the vitamin mineral content of our food 12 supply has diminished at all, because I think that’s a 13 really important one that would affect food, you know, 14 whether it’s adequate food intake that’s there. And, I 15 don’t know, with some depleted soil -- you know, I read 16 lots of stuff. I haven’t looked at this 17 systematically, but I know the Beltsville sort of 18 their, their database, I don’t know how often it is 19 updated, because I don’t think we can assume that 20 something that was looked at, how much -- you know, 21 betacarotene is in a carrot or vitamin C is in a 22 whatever -- broccoli -- is the same 15, 20 years ago as Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 171 1 it is now? 2 DR. POST: If I can -- if I can add, at least an 3 information source, the Center has what it calls the 4 U.S. Food Supplies since 1909. 5 DR. NELSON: Right. 6 DR. POST: And we can definitely look at the -- in 7 terms of the best NHANES and other data available where 8 we are on certain nutrients that you might be 9 interested in, and certainly work with ARS. 10 DR. NELSON: Because I do wonder if there has been 11 a serial change in the nutrient richness of our fruits, 12 vegetables and grains, and even meats, et cetera. 13 Pork, fish -- I don’t know. 14 DR. RIMM: Yeah. This is Eric Rimm. I am sure 15 some of it has -- some of it is due to just changes in 16 processing methods. Some of it is due to, you know, 17 fish farming. You have over time fed fish slightly 18 different things and then gone back to what they did 19 originally, so that it’s not just the micronutrients, 20 it’s also the N-3 fatty acids and other things. So, I 21 am sure that as they processed whole grains differently 22 that they took some things out and put some things Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 172 1 back, so. 2 DR. NELSON: Yeah. 3 DR. SLAVIN: This is Joanne Slavin. There are 4 differences with nutrients. Selenium is notorious, you 5 know, linked to the soil, so that varies a lot. Other 6 nutrients really don’t vary that much. And one of my 7 students did an organic versus a conventional 8 comparison, and a lot of times conventional agriculture 9 you have higher nutrient cultures than you do in 10 organic just because they are put on top of it. So 11 it’s not - a lot of times it’s not what people think, 12 the answer they are expecting, of what’s been 13 published. And there has actually been quite a bit 14 published in that area. 15 DR. NELSON: So I wonder, as a committee -- I 16 mean, we are in discussion aren’t we, within this sort 17 of segment? 18 DR. VAN HORN: Yes. 19 DR. NELSON: I wonder, as a committee, how we 20 should address any of that, because I think that falls 21 within our subcommittee and it might be worth having 22 somebody come in and give us -- someone that really Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 173 1 works in this from Beltsville or somewhere else in some 2 future meeting, or we can certainly look at it, but -- 3 DR. ACHTERBERG: This Cheryl Achterberg. To go 4 along with that, thinking about the globalization of 5 the food supply, I am not aware of whether we have a 6 database that would indicate what proportion of our 7 diet now, the American diet now is derived from 8 imported foods. And if we are going to be thinking 9 about agricultural practices and how that affects 10 nutrients in foods, we have to think about that as 11 well, and I am not aware of a data set that has that 12 info. 13 DR. POST: Yeah. Since Cheryl -- this is Rob Post 14 -- was looking at me, I will respond. I am not sure 15 that we can make that distinction at this point either, 16 at least in our involvement in the Center, but we can 17 certainly look at the data sources and see if there is 18 that kind of status. I am sure there is data on it. 19 If I can add one more point? Country of origin 20 labeling isn’t fully in place and unified globally yet, 21 so that might be one way. 22 DR. VAN HORN: Larry, and then Tom. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 174 1 DR. APPEL: Yeah. I wanted to follow up on a -- 2 there seems to be a recurring theme here about 3 patterns. I had an interesting conversation with Tom 4 last night. He said, you know, there are no heart 5 attacks in Grenada, okay? And should we consider 6 questions that are a little bit out of the box, like 7 what, you know, what dietary patterns in which 8 countries are associated with longevity and what are 9 the common characteristics of those, as a different 10 type of question that we might ask to get at some of 11 these, you know, broader issues. You know, we tend to 12 look at within country, but you know the greatest 13 contrasts and exposures are often across countries, and 14 you know, it’s a little bit different and it’s not 15 going to be randomized trials, but I think they can be 16 very informative. 17 DR. PEARSON: I was -- this is Tom Pearson. I 18 will agree with Larry, that you have listed a large 19 number of issues and, Shelly, with your review here, 20 obviously identified a number of shortfall issues. I 21 guess one of the questions is, how are you going to 22 prioritize those? I mean, are you just going to kind Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 175 1 of toss them out there, or can we relate those to some 2 sort of a public health outcome? Because otherwise, 3 this is an enormous target list that I think might not 4 be the best advice to HHS and the Department of 5 Agriculture in terms of which ones that we really need 6 to work on. So I just throw that out as a challenge 7 that I think, as you pick from these, even with the 8 evidence you have of shortfall areas, you know which 9 ones of those you -- and how are you going to 10 prioritize those? 11 DR. NICHOLS-RICHARDSDON: Well, that’s an 12 excellent question and I am open to suggestion and 13 recommendation for how our subcommittee does that, and 14 I think that will probably be a large part of our 15 initial discussions. And I think that some of the 16 discussion too, because the Dietary Guidelines do 17 inform national school lunch and breakfast programs, 18 and they do inform WIC program, and they do inform some 19 of these other programs, that if we can look at what is 20 it that perhaps those programs need to be able to 21 deliver the best nutrient supply through what they are 22 doing, that may be one approach. And I guess, you Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 176 1 know, to go back to what Joanne commented on, that the 2 nutrients are within those foods and if we are missing 3 the mark based on our Healthy Eating Index information; 4 if we are missing the mark from a whole foods total 5 food, total diet dietary approach perspective, then the 6 nutrients within those maybe don’t matter as much. So, 7 if we can address some of the big picture, dietary 8 patterns, whole foods, food approach, that that may be 9 one of the first avenues too, so. But I am open to 10 each and every suggestion for how to tackle all of the 11 different nutrients. 12 DR. SLAVIN: All right. This is Joanne Slavin 13 again. I’d like to follow-up on that, because you know 14 it’s really -- we would like people to do the dietary 15 patterns that we have already recommended; therein they 16 would get nutrients. Well, if they don’t do the 17 dietary patterns then they don’t get these nutrients; 18 do we put the nutrients in the food? I mean, you can 19 see -- and if you look at the list of nutrients that 20 are there, the ones that are biggest, like fiber is 21 half, magnesium -- it’s not different from what we 22 usually see in nutrition studies. There are certain Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 177 1 nutrients that right now people don’t, on surveys, 2 don’t get enough of. So, how do we -- can we make food 3 recommendations to get people to those, or do we think 4 of other ways to get it in the diet? It really does 5 open the door for, is there a need, like the folic 6 acid, to supplement certain nutrients if we are making 7 no progress in getting them into the diet, you know, 8 population? 9 DR. NELSON: This is Mim Nelson. One question I 10 have for just maybe an overall question -- it sort of 11 gets a little bit what you were asking is -- it seems 12 to me that one of our charges tonight is sort of to 13 defer to the Chair and the Vice Chair, but if there are 14 nutrients in which, that were identified in here were 15 the same issues -- I mean, it’s like -- I am thinking 16 of calcium for example; we still don’t get enough 17 calcium. I don’t know that I have seen a lot of 18 evidence that it should be, at the moment, until IOM 19 does more, that it’s going to be, you know, radically 20 changed, at least, I’m fairly up on the calcium. It 21 seems to me that, as a committee, in terms of 22 prioritizing, we don’t necessarily need to spend a lot Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 178 1 of time on things that are identical, pretty much the 2 same here. That would be my bias, because we have a 3 lot of other things. It may be, as you said, Joanne 4 and Shelly, that it might be that we have to figure out 5 a different way to, if there is evidence, to present 6 the data or to discuss how you actually get people to 7 get more, you know, fruits and vegetables or calcium- 8 rich foods. It may be a different framework in how we 9 present it, but the data for a lot -- I’m not going to 10 say the majority, because I don’t want to say that at 11 this point now, but for a lot of the nutrients in this 12 subgroup, it seems to me the issues are the same. We 13 still have a gap; nothing has changed. I mean, there 14 are a few more studies that sort of make me have more 15 confidence in it, but it’s sort of the same. I think 16 that we should spend more time on identifying those 17 nutrients where things are quite different, or we need 18 to frame how we tell people how to it differently. 19 But, I defer to you in terms of what our charge is as a 20 committee. 21 DR. VAN HORN: Right. Well, I think you all have 22 done a fabulous job with the discussion at this point Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 179 1 and -- oh -- 2 DR. WANSINK: This is Brian Wansink. We would 3 like to make a point and circle back to the provocative 4 comment that Larry had about looking at some of these 5 out of the box methods and possibly coming up with 6 answers. While I think that’s a tremendous hypothesis 7 generation tool, we want to stay focused on what the 8 published science says about these things. What that 9 can do though, it can direct us to scientific studies 10 that have been conducted in areas we might not have 11 examined, but we always want to stay focused on the 12 science. I appreciate that comment though. 13 DR. APPEL: Well, the science is ecologic studies. 14 If you document, you know, that the country with the 15 highest number of centenarians and you can document 16 their, aspects of their diet that are also, you know, 17 linked -- let’s say Okinawa with 85 percent carbs, 18 almost all vegetables, less fruit, then you know, that 19 reinforces what we are doing. It’s a different form of 20 that, but it’s still evidence. 21 DR. VAN HORN: Well, and I think that also 22 introduces the topic of healthy aging and the fact that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 180 1 we now have the capacity, because of some of these 2 long-term epidemiologic studies that have been going on 3 for 20 or 30 years, to actually look at those 4 associations longer term, which we have not had prior. 5 So I do think -- I would agree completely that the 6 science is available and we should take a look at it, 7 because it hasn’t been, you know, viewed prior to this. 8 The other comment that I would just throw out, 9 because I haven’t, I don’t think, heard anyone mention 10 it, is the whole notion of bio availability of various 11 nutrients and, you know, this whole concept of certain 12 nutrients perhaps being more available even in a 13 smaller quantity when the background diet is mostly 14 plant-based. You know there are certain studies, and I 15 think -- I always find these just fascinating to 16 demonstrate that a vegan, you know, absorbs more iron 17 from vegetarian-based sources than a non, you know, 18 than an omnivorous person because they simply have less 19 access to it. And that’s just one example. But, the 20 point being that if we are going to be advocating a 21 diet that enhances general good health, you know, what 22 is the composition of that that really optimizes the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 181 1 absorption of all the nutrients regardless, you know, 2 of what level they are because the background diet is 3 something that sustains that level of absorption. And 4 I haven’t seen that really raised in previous 5 discussions, but it might be worth doing, because I 6 think it’s available now, and it probably hasn’t been 7 prior. Yeah. 8 DR. POST: This is Rob Post. I just wanted to 9 follow-up on the comment of I guess Brian’s in the 10 follow-up. The countries are so different in terms of 11 their food availability and lifestyles, so I am sort of 12 pointing to a need to consider the kinds of studies 13 that we look at to base Dietary Guidelines for 14 Americans and consider that in the discussion, and that 15 there may be some disparities that make these not 16 necessarily totally applicable at the end of the day. 17 DR. FUKAGAWA: But we do -- this is Naomi Fukagawa 18 -- do have to consider that our country is much more 19 diverse and that perhaps not considering the cultural 20 differences that may exist and patterns may be why we 21 appear, by surveys, missing the mark. And so I think, 22 you know, we do live in a much more global world now Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 182 1 with a lot more communication, so I think it’s very 2 hard to know who do we define as American. I mean, you 3 know? 4 DR. VAN HORN: Good point. Good point. 5 DR. NELSON: Also, I have one other comment. 6 DR. VAN HORN: Yes. 7 DR. NELSON: It gets to both Joanne and also I 8 think, Brian, you brought this up, or maybe it was you, 9 Rob -- that I think one thing that is possibly also 10 different is that the more -- you said it, but I just 11 -- I think it’s important to reiterate it, that the 12 more -- I don’t want to use a bad word here -- but the 13 more processed snack foods, crappy foods, whatever you 14 want to say and however you define that, that we bring 15 into our diet, the more calories we are getting and the 16 fewer nutrients we are getting. And so I think one 17 thing that hasn’t been dealt with has been the 18 decreasing of the sort of negative aspects of the diet 19 that goes maybe even beyond the Healthy Eating Index 20 because we are so sedentary that we need to make every 21 bit of food that we eat count in terms of these 22 nutrients, otherwise we are going to have to just rely Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 183 1 on functional foods and supplements. And so, I think 2 the positives and emphasizing even more the negatives 3 may be important from this and maybe the energy 4 balance, but these two committees in particular. 5 DR. VAN HORN: Go ahead. 6 DR. CLEMENS: Roger Clemens. It’s really 7 interesting to note that much of the food industry has 8 actually taken the Dietary Guidelines to heart, and to 9 your excellent comment, Linda, there regarding the bio 10 availability, we know that a number of foods have been 11 fortified with certain salts, such as calcium salts, 12 and those salts have been demonstrated to be quite bio 13 available. I think it’s quite encouraging, in an 14 effort to meet these apparent deficits in the various 15 nutrients and identified by this illustrious group that 16 the industry has responded in a very positive way, in 17 an effort to meet those nutrient deficits we see in a 18 number of population groups. 19 DR. VAN HORN: Go ahead. 20 DR. PREZ-ESCAMILA: Rafael Perez-Escamilla. And 21 the comment I want to make is regarding the importance 22 of making the recommendations that actually people can Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 184 1 implement. And when it comes to your subcommittee and 2 the whole issue of, for example, fresh fruits and 3 vegetables, and fish and so on, the issue of access to 4 those foods by a large segment of the population is one 5 that is of a lot of importance. And, communities may 6 not have access for two reasons; physically, you know, 7 the places where they buy their foods may not have the 8 healthy foods we are recommending; and also the price 9 and the cost. And I know that these issues have been 10 brought up by Joanne and Cheryl. So, what I think is 11 also very important is to keep in mind that the local 12 food systems play a very important role in determining 13 access to, for people to implement their 14 recommendations that we are going to make. And, as 15 part of our deliberations and discussions, I think it’s 16 important to try to gain a better understanding of how 17 different food systems work in the country at different 18 levels. 19 DR. ACHTERBERG: Cheryl Achterberg. To add to 20 this discussion, this is coming from a different 21 perspective, a different slant, but again, if we want 22 our recommendations to be followed by the general Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 185 1 public, I think we have to consider that perhaps the 2 way we group foods or structure this advice may -- 3 based on -- based on science, based on taxonomies, 4 based on botany hundreds and hundreds of years old, 5 that might not make sense, in terms of the dietary 6 guidance we give, particularly as it relates to 7 vegetables. For example, tomatoes, what are we going 8 to do with that poor tomato? Is it a fruit; is it a 9 vegetable? It’s an other right now. There are things 10 that we do when we give food advice structuring things 11 that might not make sense in practice, so I am going to 12 invite the Committee to get out of that box too and 13 think perhaps there are other ways to sort this. Not 14 that there is a pile of scientific studies to do this 15 by, but the science we are using may not be relevant at 16 all to the problem in hand. 17 DR. VAN HORN: All right. Well, that was a very 18 -- dare I say it -- fruitful discussion. Sorry -- just 19 couldn’t help it. But, having said that, I think we 20 should take a five-minute stretch break before we 21 launch into the electrolyte discussions. So, just 22 literally five minutes, just stand up, stretch, and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 186 1 we’ll let the next group get ready. 2 (Whereupon, at 2:54 p.m., a brief recess is 3 taken). 4 DR. VAN HORN: Okay. While we are waiting for Dr. 5 Appel, who is the Chair of this next group that will 6 review fluid and electrolytes, I really neglected, for 7 the purposes of the rest of the group out there, to 8 mention that these committees were assigned to review, 9 as is probably obvious from the nature of the 10 presentations that were just made, but just to 11 summarize everything briefly, we were charged with 12 reviewing what is the established science in the area; 13 what are the recent scientific advances; where is there 14 consensus in the science; what issues need further 15 discussion or further evaluation of the science; what 16 issues need additional expertise, guest speakers, et 17 cetera; what issues require additional information, 18 such as, again, consumption data, as we were just 19 discussing; and how does this relate to the 20 Government’s federal policy recommendations in the 2005 21 Guidelines for Americans. So, the nature of the 22 discussion that you are hearing, and again, I would Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 187 1 like to just compliment the first group and how amazing 2 they were in putting together so much information in 3 such a really short amount of time, so I think 4 everything that you are hearing represents true 5 expertise, because if they were able to pull that 6 together in such a heartbeat, then it clearly indicates 7 that they have it in their back pocket. So, without 8 that, certainly Dr. Appel has the same in terms of 9 electrolyte questioning. 10 DR. APPEL: Can people hear me? All right good. 11 Because I had some problems with the microphone 12 earlier. 13 Okay. So we are going to talk about food and 14 electrolytes, and one thing I want to point out is 15 that, in the 2005 Dietary Guidelines, it really was 16 water and electrolytes, you know, and I think one of 17 the issues that we have to decide is like where do 18 these types of fluids fit in. You know, if we do sugar 19 sweetened beverages, does that go under carbs; does 20 that go under energy balance; or does it go under fluid 21 and electrolytes? So, in terms of an outline of what I 22 am going to cover, I’ll review the 2005 Guidelines Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 188 1 research questions and conclusions, and then our key 2 research recommendations, and then prepare, in 3 preparation for these, the current Guidelines, review 4 some new evidence and new emphases, potential new 5 questions and potential guest speakers. 6 So, as we discussed earlier, we are responsible 7 for the Blue Report, and so I’ll mention the 8 conclusions and recommendations. There actually was a 9 little bit of migration between the Blue Report and the 10 Dietary Guidelines for Americans, the 2005 document on 11 the right. The sodium guideline was less than 2,300 12 without qualification. The Blue Report, and on the 13 report on the right, it was actually qualified further, 14 2,300, except if you are middle-aged or older, are 15 hypertensive or African-American, in which case you 16 should have goal of 1,500. 17 So, there has been a detention here as to what, 18 you know, how much in terms of sort of background 19 material to provide, to provide a context for the 20 recommendations, so I just -- I took the liberty of 21 having a little bit of background before the questions 22 and conclusions. So, in terms of adverse effects of Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 189 1 salt intake, there is a -- I would call it an 2 established relationship between excess salt intake and 3 blood pressure, and there is a variety of evidence to 4 support that. And it used to be that this would, that 5 its relation, salt’s relationship with CVD was just 6 indirect evidence that you had salt with blood 7 pressure, and then separate evidence of blood pressure 8 with CVD and stroke. But, there now have been a few 9 trials -- not too many -- all pointing in the direction 10 of salts, a reduced salt intake leading reductions in 11 CVDs and stroke. 12 Then, in terms of a probable relationship, which 13 you didn’t cover in the last report, which would be an 14 interesting question, but it’s not as big a public 15 health problem as gastric cancer -- and there is 16 actually excellent ecologic evidence relating intakes, 17 higher intakes of sodium with gastric cancer, and then 18 I forget the actual name of that international report 19 on cancer, but it was listed as a probable 20 relationship. Suggestive relationship of high salt 21 intake with osteoporosis and increased left ventricular 22 mass -- interesting, but I am not sure if it were Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 190 1 sufficient to guide policy; and then hypothesized 2 relationship that as salt intake increases, so does 3 fluid intake, and that fluid intake has calories in it 4 that it could lead to overweight, obesity, and there is 5 actually some data on that. But this is my hierarchy, 6 and you know, we might want to revisit some of these, 7 and particularly the latter given the obesity epidemic. 8 So, you know, I think everybody realizes that 9 cardiovascular disease, stroke and heart disease are 10 the leading cause of death worldwide, and of that, in 11 terms of underlying factors causing death, when there 12 has been a partitioning of the causes, raised blood 13 pressure is really right up there at the top, and so it 14 deserves a lot of emphasis from this committee as a 15 chronic disease, even though we don’t have a 16 subcommittee that focused explicitly on blood pressure. 17 I guess that’s somewhat subsumed under electrolytes and 18 fluids, although nutrient adequacies is probably 19 covered as well. 20 So, in terms of where we stand in terms of the 21 blood pressure distribution, 42 percent normal; about a 22 third pre-hypertensive; and about just under 30 percent Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 191 1 hypertensive, but that ignores what happens with aging 2 and basically, as we age, blood pressure rises 3 insidiously to the point where almost everybody has it 4 by the time they reach their 70s, and 90 percent of 5 individuals will develop hypertension in their 6 lifetime. 7 So, here is a summary of evidence relating salt 8 intake to blood pressure. There is epidemiologic 9 evidence, ecologic studies, as well as cohort studies. 10 The best studies are actually across populations, not 11 within populations, because you have greater exposure. 12 And also, there are differences, quality differences, 13 depending on how well sodium is measured, and it’s a 14 very nasty variable to measure well in epidemiologic 15 studies. Really, you should do 24-hour urinary sodium 16 excretions to do it right, and a lot of studies don’t 17 have that. 18 Migration studies, all genetic defects that have 19 been associated with hypertension actually impact the 20 kidney and its ability to excrete salt, a lot of animal 21 studies. We have clinical trials in children, and I’ll 22 show you some recently published data about 10 trials. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 192 1 I think there could be better trials, but on average, 2 there is a small but significant reduction in blood 3 pressure. One trial in infants; adults greater than 50 4 trials; and then there are population interventions in 5 northern Japan, Portuguese villages as well. 6 So this is just one trial-sodium trial, which 7 document that as you reduce sodium intake from a higher 8 level, in this case, 3,300, to a lower level, 1,500, 9 you get really a large reduction in systolic blood 10 pressure. I’ll note that the higher level is still not 11 the average in the United States and that individuals, 12 particularly middle-aged men, they are up in there 13 averaging around 4,500 or so, so getting down -- I 14 mean, this -- we are not showing data here that 15 represents the potential benefit given the current 16 intake. Now, in this case the controlled diet was a 17 diet typical of what many Americans eat, and then there 18 is the DASH diet, which is not typical of what many 19 Americans eat, less than 5 percent of the population, 20 but this is a nutrient-rich diet, dietary pattern, but 21 you still see blood pressure reduction, in this case, 3 22 millimeters of mercury systolic, which have public Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 193 1 health benefit. 2 So, in terms of research questions that we 3 considered in 2005, as I said, we talked about fluids, 4 as well as the electrolytes, so what amount of fluid is 5 recommended for our health? And so, this was the 6 summary statement. The combination of thirst in usual 7 drinking behavior, especially the consumption of fluids 8 with meals is sufficient to maintain normal hydration. 9 And I actually want to -- I still remember a comments 10 -- piece of news -- it is not normal, but usual, and 11 we’ve got to be really careful with what we -- with our 12 terminology that -- directly, I should footnote that or 13 give you a reference for that. Second, healthy 14 individuals who have routine access to fluids and who 15 are not exposed to heat, stress consume adequate water 16 to meet their needs. We know there is no such 17 condition as chronic dehydration. And, three, 18 purposeful drinking is warranted for individuals who 19 are exposed to heat stress or perform sustained 20 vigorous activity don’t interestingly have the chronic 21 disease outcome on this. So we felt at least in the 22 IOM panel that there really were not, you know, enough Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 194 1 evidence. But, I think one could potentially revisit 2 kidney stones and one could potentially revisit bladder 3 cancer as two possible outcomes. I am unaware of any 4 trials in this area. 5 So, the second research question, what are the 6 health -- what are the effects of salt, sodium, 7 chloride intake on health, and the first conclusion was 8 that the relationship between salt, sodium chloride 9 intake and blood pressure is directly progressive 10 without an apparent threshold; hence individuals should 11 reduce their salt intake as much as possible. 12 In view of the currently high levels of salt 13 intake, a daily sodium intake of less than 2,300 14 milligrams is recommended. So there is -- this is 15 actually -- the nuance to this is that some of our 16 conclusions were nuanced on the current supply, I mean, 17 the current intakes, you know? And, if you were 18 actually at 2,300, maybe going down to 1,500 would be 19 great, but you know, you have to be practical, as 20 people have pointed out in our earlier discussion. So, 21 more individuals will benefit from further reductions 22 in salt intake, including hypertensive individuals, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 195 1 black and middle-aged and older individuals, and I 2 think that was the basis for the subsequent decision to 3 lower the 2,300 milligrams to 1,500 milligrams. 4 And lastly, individuals who currently increase 5 their consumption of potassium, because a diet rich in 6 potassium blunts the effects of salt on blood pressure. 7 So this is the question about potassium; what are 8 the effects of potassium intake on health? Diets rich 9 in potassium can lower blood pressure and lessen the 10 adverse effects of salt on blood pressure. 11 Interestingly, it may reduce the reduce the risk of 12 developing kidney stones and possibly decrease bone 13 loss, which I think is really very interesting, and I 14 am aware of, that there is interest in potentially 15 doing a large trial without outcomes, such as bone 16 mineral density, but as far as I know, there is no 17 trial that has been done since 2005 with bone loss, and 18 I think this is particularly important given some of 19 the Women’s Health Initiative (WHI) results on calcium 20 Secondly, in view of the health benefits of 21 potassium and its relatively low intake, at least 4,700 22 milligrams are recommended, and blacks are especially Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 196 1 likely to benefit from an increased intake in 2 potassium. 3 So, in terms of research recommendations, I’ll 4 just go through what we listed. I would sort have the 5 caveat that I think that as this Committee moves 6 forward, we should also keep on cataloging my 7 experience on these committees, and dietary guidelines 8 is no exception, is that this is done last without as 9 much consensus building, and you know, if we want to 10 put our teeth into some research recommendations that 11 actually lead to research being done to informed 12 guidelines, we probably should spend a little bit more 13 time on this than just leaving it to the last meeting. 14 But anyways, this is what we recommended; 15 investigate the implications on the intake of bottled 16 water, on fluoride intake and on health outcomes, 17 because evidently bottled water has -- it doesn’t have 18 fluoride; compare the effects of foods and beverages 19 that contain added sugars and those that naturally 20 contain sugar on body adiposity and other indicators of 21 health. It might be a turf battle among subcommittees 22 to take that one on. I don’t know. Investigate the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 197 1 role of increased total fluid intake as a means for 2 preventing chronic diseases. 3 So, research recommendations related to sodium and 4 potassium; conduct trials that assesses the effect of 5 salt intake on a clinical outcomes other than blood 6 pressure -- and there actually has been some data on 7 this; conduct trials that test whether increased 8 potassium intake or potassium-risk foods increase bone 9 mineral density -- I don’t think those trials have been 10 done -- and conduct those response trials that test the 11 main and interactive effects on sodium and potassium 12 intake on blood pressure and other clinically relevant 13 outcomes -- and I don’t think that’s been done. 14 So that’s from 2005. Now, in terms of 2010, what 15 we might think about, given some new evidence and new 16 emphases that are percolating in our professional 17 societies, first of all, new evidence. The blood 18 pressure status of Americans is getting worse, not 19 better. Secondly, evidence of reduced -- of the 20 benefit of reducing salt and increasing potassium on 21 CVD events, we have some trial evidence. And, I think 22 there is increasing concern about blood pressure in Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 198 1 children; that we are actually seeing some pretty 2 adverse trends already, and I think this could be one 3 of the more important research questions or emphases we 4 have in our report. So, in terms of the population 5 trends for blood pressure or hypertension, these are 6 data in adults between two of the NHANES surveys. What 7 you see is, in older age individuals, in three age 8 groups, if you look at the figure on the left, you do 9 see hypertension prevalence going up, and it seems to 10 be occurring in all, in each of the major race 11 ethnicity groups studied in NHANES. 12 I also wanted to point out some compilation 13 evidence that I put together and was published earlier 14 this year, and that has to do with an age-related rise 15 in blood pressure in children. And, what you see here 16 is a plot by age of mean blood pressure in children, 17 and what’s striking is that the average age-related 18 rise in blood pressure is roughly at least two, but 19 maybe up to three times as fast as in adults. In 20 adults it’s roughly .6 millimeters of mercury per year, 21 and in boys it’s 1.9 and girls 1.5 millimeters of 22 mercury. And what I have put simultaneously on the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 199 1 right are average levels in middle-aged, Yanomami 2 Indians, who have a low sodium population where there 3 is no age-related rise in blood pressure. So, among 4 Yanomami men, their average systolic blood pressure is 5 101, which corresponds to a mean blood pressure in U.S. 6 boys at age 11. And correspondingly, for women, the 7 average blood pressure in Yanomami women is 91, which 8 maps out to an average blood pressure in girls at age 9 six. So the genesis of the blood pressure epidemic, 10 even though we have been focusing on middle or older- 11 aged individuals is really early age and I think should 12 be an emphasis of what we do in terms of preventing 13 chronic disease starting pretty early. 14 Blood pressure trends are actually going worse in 15 the United States. This is data from Paul Muntner, 16 published in 2004. Basically blood pressure is going 17 up partially accounted for by weight. By the way, in 18 terms of the pathophysiology, there is reason to 19 believe that insulin resistance may raise blood 20 pressure, but also I think you need to realize that 21 when individuals are consuming more food, they are 22 consuming more sodium, okay, at the same time. So we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 200 1 need to acknowledge that as a possibility or a 2 contributor of these adverse changes. 3 A meta-analysis was done by MacGregor two years 4 ago. The evidence is pretty diffuse in terms of the 5 type of trials that were done, but on average, one 6 millimeter, you know, mercury reduction systolic and 7 diastolic from reducing sodium. 8 Now, in terms of clinical outcomes, there are 9 three studies, one of which was available to us. It 10 was the TONE study. I participated in this, and this 11 had 639 elderly hypertensive individuals. There was a 12 behavioral intervention, and there was a non- 13 significant trend towards a reduced risk of 21 percent 14 of CVD events, a composite of events over 2.3 years. 15 The year after the Dietary Guidelines were published, 16 there was a clinical trial done in Taiwan veterans -- 17 that was in 2006 -- and it was substitution of usual 18 salt with a low sodium, high potassium salt, and there 19 was a statistically significant 41 percent reduced risk 20 of CVD mortality over 2.6 years. And then quite 21 importantly, the trial of hypertension prevention 22 follow-up study in 2007 -- this was a study that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 201 1 enrolled over -- actually two studies that together 2 enrolled over 3,000 pre-hypertensive individuals. The 3 outcome of that study during the initial phases was 4 just prevalence of hypertension, but Nancy Cooke 5 followed these people long-term over the course of 10 6 to 15 years, and there was average -- or there was a 7 net relative risk reduction of 30 percent, 8 statistically significant, and that’s demonstrated on 9 this panel here. 10 So, in terms of potential new research questions, 11 I’ll list a few here. And again, I -- you know, when I 12 am tired at night or hallucinating when I run, I come 13 up with these questions. By no means is it 14 comprehensive, but these are the ones that came, that I 15 thought about when I was anoxic. 16 So, what dietary factors influence blood pressure 17 in children and young adults, you know, are they the 18 same ones? I suspect yes. What is the evidence? 19 Should the target for sodium intake be reduced 20 from 2,300 milligrams to 1,500 milligrams? One could 21 make this argument just on the basis the population 22 itself, middle-aged and older-aged individuals, blacks Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 202 1 and individuals with hypertension, according to verbal 2 reports from people who are going to publish soon, is 3 somewhere between 50 and 60 percent of the population. 4 What are the current dietary sources of sodium? I 5 think this is actually an interesting question. We 6 actually don’t have -- I would like to actually see 7 some of this data from NHANES. You know, I think we 8 might be having -- seeing some benefit in terms of 9 reduced salt content in certain luncheon meats and 10 maybe in certain other products, like soups. I know 11 that many companies have made, you know, sizeable 12 reductions. But, we also might be having a flip side. 13 I was, the other day, I was talking with a staff member 14 and basically, you know, we might be getting more salt 15 through our chickens that are now injected with brine, 16 and so that the source of the actual, you know, where 17 we are getting it might have shifted, and I don’t know 18 if there is good data on this. 19 Other potential questions -- we did not address 20 this in 2005; what are the effects of certain 21 beverages, coffee and tea, on the CVD and its risk 22 factors? I know, Tom, you have been interested in Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 203 1 this. You know, we have to decide whether this is an 2 important enough topic to address. What are the 3 effects of sugar-sweetened beverages, beverages with 4 artificial sweeteners and water on weight in children 5 and adults, which I think is a topic that we will 6 address, and probably other people have thought about? 7 In terms of potential speakers, I thought that 8 Steve Daniels would be very good on blood pressure in 9 children; in terms of weight-effective beverages, Barry 10 Popkin and Caballero; and in terms of sodium 11 recommendations, Frank Sachs. 12 So, I’ll end with a comment. This is an 13 observation from 2005. So the question is, how big is 14 our task on the committee? So, at the end of the 15 committee, I actually measured all of the paper -- I am 16 a bit anal compulsive at times. I saved all the paper 17 I got, and it turns out that that paper weighed 109 18 pounds; it was 60 inches tall; and if you calculate the 19 BMI, its 21. And so, our task is normal-sized , not 20 huge. 21 DR. VAN HORN: That was reassuring. Thank you. 22 DR. APPEL: No, it’s not. Can we open this up for Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 204 1 discussion? Christine, yes? 2 DR. WILLIAMS: Christine Williams. I just wanted 3 to echo my concerns about high blood pressure trends in 4 children. In addition to the study by Muntner that you 5 summarized, there was also a study in circulation last 6 year by a Dennis Athem, and they found that high blood 7 pressure and pre-high blood pressure in children and 8 adolescents actually decreased between 1963 and 1988, 9 but then an increase was seen between 1988 and 1999. 10 An ethnic and gender gap appeared in 1988 for pre-high 11 blood pressure, and in 1999 for high blood pressure, 12 especially non-Hispanic blacks and Mexican Americans 13 with a greater prevalence of high blood pressure and 14 pre-high blood pressure than non-Hispanic whites. And 15 males had a greater a prevalence than females. Pre- 16 high blood pressure increased by 2.23 percent and high 17 blood pressure by one percent between 1988 and 1999, 18 and obesity increases more so abdominally than general 19 partially explain the rise in high blood pressure. 20 We also did a study in preschool children, 21 published in 2004, where we studied almost 1,000 22 preschoolers between the ages of three to five, and we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 205 1 found that overweight preschoolers at this young age 2 had three times the risk of having elevated systolic 3 blood pressure than non-obese preschoolers. We then 4 followed up these children to ages seven and eight, and 5 the overweight children whose weight normalized had a 6 much less increase in systolic blood pressure over time 7 compared with the children who gain weight rapidly. I 8 think it’s especially of concern when you look at the 9 facility for potassium intake in the most recent NHANES 10 study, because in children from ages two through 19, 11 the really haven’t changed much. And the unfortunate 12 thing is that the majority of children are above the 13 upper limit for sodium and do not meet the requirements 14 for potassium. So I think especially in the new 15 Dietary Guidelines we need to emphasize perhaps more 16 strongly the need to meet those guidelines for sodium 17 and potassium, and especially to work on energy 18 balance. 19 DR. APPEL: Yeah. The question to me -- yeah, I 20 think we can -- I mean, I think we need to deal with 21 blood pressure as an issue, but I think more broadly 22 primordial prevention of cardiovascular disease in Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 206 1 children. And I know that, in terms of reports, I have 2 heard that there is an NHLBI Committee that’s going to 3 have, that evidently has compiled evidence and we might 4 not want to re-invent the wheel if they have already 5 done this, and I understand this report might come out 6 in April or May of this year. And if, you know, if we 7 can, you know, be somehow linked to that it might help 8 us. 9 DR. WILLIAMS: I think Steve Daniels would be 10 excellent, or perhaps Ray Allen Caby from NHLBI could 11 do that. 12 DR. APPEL: I’m sorry. Who was the second? 13 DR. WILLIAMS: Ray Allen Caby, Dr. Caby, who 14 coordinates that committee. 15 DR. NELSON: Well I just -- the question about 16 coffee and tea I think is an interesting one possibly 17 more with tea than with coffee. I don’t know. I mean, 18 I think that there is some more evidence around some 19 benefit, and I think it may be worth at least doing a 20 cursory look at some of the literature. 21 DR. APPEL: Yeah. I think -- you know, I don’t 22 know enough about this to make the call and I think Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 207 1 this actually gets at a process issue, which is, like 2 when we have a little bit of a signal, how much of a, 3 you know, how much of a review of the literature do we 4 do and how do we do this? You know, it might be that, 5 you know, we have -- we save our, you know, Joan Lyons 6 and her teams for the, you know, for those, you know, 7 the final questions, but then we have this larger group 8 where we decide to make a decision about, that we have 9 to do something else, you know, and what that looks 10 like, we have to decide. 11 DR. RIMM: Yeah. I think that -- this is Eric 12 Rimm -- I think that, as an epidemiologist who has been 13 on coffee papers for the last 20 years, I don’t think 14 it’s necessarily that new of something to study coffee 15 in cardiovascular disease, because you will find here 16 are 50 papers and literature, and there have been 17 formal analyses, and I don’t necessarily know what the 18 direct -- what we would write into the Dietary 19 Guidelines saying that people should drink coffee or 20 should not drink coffee. I think maybe, if there are 21 more subtle issues related to tea and blood pressure, 22 because tea consumption maybe has changed more, but Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 208 1 some of your other questions -- maybe just because you 2 were running too hard when you did the coffee one -- 3 but I think coffee sort of has been kicking around for 4 a long time and we’ll find that there is a lot of 5 literature on it, and I’m just not sure what the -- 6 DR. APPEL: Direction? 7 DR. RIMM: We may find it’s good among diabetics, 8 but I am still not sure if we change it, make a dietary 9 guideline based on that. 10 DR. APPEL: yeah. But that issue about the coffee 11 and diabetes, I know that your group has been 12 interested in that and there might even be a trial on 13 that, but we might just say we don’t -- we are not 14 going to talk about it at this time, because you know, 15 there is better evidence coming down the pike. 16 DR. PEREZ-ESCAMILLA: Can I put also on the second 17 one, on that; is it related to coffee and tea? Okay. 18 Just very quickly, Rafael Perez-Escamilla, from the 19 consumer’s perspective, I believe people out there will 20 be extremely interested on learning about what we know 21 about coffee and tea and cardiovascular disease, 22 because you know, people drink them and they often ask Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 209 1 about it. 2 DR. PEARSON: Let me just comment on that. We 3 have published on this area in the past, and which has 4 a very interesting historical perspective. I will 5 agree with Eric, I’m not sure in the last ten years 6 where there has been anything elucidative. There are 7 some very large studies, which were complicated by the 8 methods of brewing. I think some of the mechanisms 9 through terpines being released, particularly by high 10 extraction, in fact it looked like there was a lipid 11 connection, and in fact the kinds of coffees that do 12 that, the Norwegian coffees; the Turkish coffees; and 13 other coffees in fact look like they have had a 14 relationship with cardiovascular disease. In the 15 United States, the early studies, including one that we 16 did dating back to the 1950s and 1960s, showed a 17 relationship which has not been replicated since, but 18 some of us believe has to do with the coffee brewing 19 methods, and the fact that the terpines stick onto 20 coffee filters. And so, I think because we view it out 21 of interest and perhaps the Guidelines hasn’t done it 22 before, but I’ll side with Eric that I don’t think Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 210 1 there has been anything. 2 Now on the tea side, I think there are more 3 interesting things there because of other mechanisms, 4 and I think there are quite a number of studies with 5 anti-platelet effects and a variety of other 6 mechanisms, pharmacologic mechanisms, bio-flavinoids 7 and other compounds, particularly in the green tea 8 line, which would support them having a 9 cardioprotective effect, and in that instance, with a 10 neutral coffee versus a protective tea, you might have 11 some trade-off if you are going to, if you are like in 12 Rochester, New York freezing to death most of the time 13 and want a hot beverage, there may be a choice there. 14 But I think there really hasn’t been a large number. I 15 think 50 is probably an underestimate, Eric, when you 16 take in the international data on this area on coffee. 17 DR. CLEMENS: I’d like to remind us -- this is 18 Roger Clemens -- I’d like to remind us of (1), as the 19 pick-up of what Shelly said earlier today; that no 20 nutrient stands alone, and we might, in 1924, just a 21 few years ago, that the United States fortified the 22 salt in the United States with what? Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 211 1 DR. PEARSON: Iodine. 2 DR. CLEMENS: Iodine. That technology has not 3 changed. If you look at the World Food Program 4 sponsored by WHO, that particular program is 5 encouraging increased sodium chloride content in the 6 diet because of the iodine delivery, and that iodine 7 delivery is helping children to improve the cognitive 8 performance and neurological development. In this 9 country, maybe that isn’t the issue, and 10 internationally, the CDC is sponsoring and supporting 11 this kind of a program by WHO, and it would be 12 interesting then, in fact, if one side of the 13 government is telling them to reduce sodium and the 14 other side of the government says increase your sodium? 15 DR. APPEL: Yeah. But I think that, you know, we 16 have to look at where there is, where there are public 17 health problems, and I think your point is well taken. 18 In certain parts of the world this is a huge issue. 19 DR. CLEMENS: Yes. 20 DR. APPEL: And then you -- and, you know, you 21 actually, you know, that could be, you know, you are 22 going to support that. In the United States it’s not Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 212 1 an issue, and in part because iodine comes from, you 2 know, we don’t have these iodine-deficient regions 3 anymore. And the other thing is that, in terms of 4 sodium -- and we had this discussion in 2005 -- the 5 sodium that’s put into our foods, the processed form, 6 there is no iodine in that, you know, or very little, 7 so that’s really contributing to solving a problem for 8 which we don’t have right now. So I think that 9 probably is not going to drive our decision-making. 10 DR. CLEMENS: One of the things that we might want 11 to consider, the fact if we increase our exercise -- 12 Larry, you and I run a little bit, and I think our 13 blood pressure is relatively low. And so, if we 14 decrease the obesity and improve the exercise 15 performance, in particular, for our young people that 16 affects in the blood pressure we see elevated they will 17 actually decrease. 18 DR. VAN HORN: All right. Other discussion on 19 fluids or electrolytes? 20 DR. FUKAGAWA: Well, I -- 21 DR. VAN HORN: Go ahead. 22 DR. FUKAGAWA: Sorry. This is Naomi Fukagawa. I Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 213 1 would like to also bring up the point though with 2 respect to this -- we are discussing added salt or 3 sodium chloride, but one of the major things that at 4 least I thought I learned in early nutrition was that 5 your ability to maintain positive protein or nitrogen 6 balance is also related to a certain amount of sodium 7 in your diet; that it’s very difficult to utilize some 8 of the amino acids to create the proteins without 9 adequate salt or sodium. So, you know, we can suggest 10 a reduction in the excess intake, but I don’t think 11 should get to the point where we might suggest being 12 too low. 13 DR. CLEMENS: Naomi -- this is Rog again -- I 14 would like to also comment on that excellent remark of 15 yours. If you recall, in the 1970s -- some of us were 16 around then -- there was a movement on hypertension and 17 sodium chloride, and as a result of that, on the infant 18 side there was a big movement to reduce the sodium 19 chloride. Well they removed the sodium, but also 20 chloride went with it and it developed very serious 21 issues, if you recall in Tennessee. And if informative 22 that promulgated the regulations in 1980 of the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 214 1 Proponent Act, we want to be sure that as we reduce the 2 sodium -- if we decide to do that -- 3 DR. FUKAGAWA: Right. 4 DR. CLEMENS: -- that it doesn’t have other 5 ramifications. 6 DR. APPEL: Yeah. But I think you need to realize 7 that that was absence of chloride. It was -- 8 DR. CLEMENS: Yes. 9 DR. APPEL: Yeah. It really wasn’t, you know, 10 reduced intake -- 11 DR. CLEMENS: Just all that? 12 DR. APPEL: Yeah, yeah. I mean, the issue about, 13 you know, protein, I think we could investigate. 14 DR. FUKAGAWA: Right. 15 DR. APPEL: But, you know, I think when you look 16 -- I mean, I didn’t go over, you know, where the 17 population is now. I mean, most -- 18 DR. FUKAGAWA: Yes. 19 DR. APPEL: I mean, we are so high, you know, that 20 the problems that you allude to are presumably are at 21 lower intakes, but you know we can investigate that to 22 make sure. But, I mean, average intakes in middle-aged Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 215 1 men who are runners is probably around 4,500, you know? 2 DR. FUKAGAWA: But I do think your point of 3 needing to know the dietary sources of sodium is 4 extremely important. 5 DR. APPEL: It could be shifting, and we don’t 6 really know that. 7 DR. FUKAGWA: Right. 8 DR. CLEMNS: Yes. 9 DR. FUKAGAWA: But we also know that protein 10 intake will help with the diuretic effect in the 11 kidneys, so you know, again it’s another sort of 12 balance of things. And I think our efforts are really 13 to try to come to a moderate group of recommendations 14 rather than making too drastic a change, I think. 15 DR. VAN HORN: Sam? 16 DR. PI-SUNYER: I just want to comment -- this is 17 Pi-Sunyer -- I just wanted to comment on your other 18 question about beverages. 19 DR. APPEL: Yeah. 20 DR. PI-SUNYER: And I think that there is a lot of 21 new data on that, and certainly one of the 22 subcommittees, whether its energy balance or Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 216 1 carbohydrates or yours really needs to look at sugar- 2 sweetened beverages and artificial sweetener beverages 3 and its effect on weight, not only in children, but 4 also in adults. 5 DR. APPEL: Yeah. 6 DR. PI-SUNYER: So, I think this is a key question 7 that we really do need to take up and, but I think over 8 five years there is significant more data than there 9 was in 2005. 10 DR. SLAVIN: Yes. Joanne Slavin. It’s in my 11 section for the beverages, the sugars, so I have 12 covered that. But I think, to have some speakers, and 13 there has been a lot of things done, it’s kind of 14 confusing, so it’s a huge topic though. 15 Food form -- how do we deliver food, whether it’s 16 solid or liquid and how does that vary the 17 physiological factor? 18 DR. VAN HORN: Right. Go ahead. 19 DR. PEARSON: Well, as a member of this 20 subcommittee, I had a couple of things that I’d like to 21 perhaps add for consideration to Larry’s list. And one 22 of them really deals with the implementation of sodium Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 217 1 restriction policies. I think the history of that has 2 been recorded, in that there have been several efforts 3 by industry to do this leading me to a marketplace, 4 which really wasn’t supporting of selling those, 5 requiring the companies to go back to higher sodium 6 products, because the low sodium ones didn’t sell so 7 very well. I’m not saying that that’s not the way we 8 want to go, but I think what we should understand a 9 little bit better is the whole development of salt 10 taste, and I think particularly relative to children. 11 And so one of the issues of a really, everybody buy in 12 sodium reduction policy, may be actually the 13 development of a generation which you could then do 14 better at the marketplace with low sodium products 15 rather than the, really the craving of sodium that 16 really would destroy the things you would want to have 17 more publicly available. You know, 90 percent of the 18 population -- according to the data that was shown 19 previously -- exceed the sodium goals, so you really 20 are not even close at suggesting that this really is a 21 widespread issue of implementation; that we can make 22 all the recommendations, in terms of the milligrams we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 218 1 want, but we are not getting the 2,300, so why should 2 be recommend 1,500? So we really need to get upstream 3 and understand why these are being rejected, or even if 4 you give somebody a low sodium product, they just take 5 the salt shaker and add to it. So, I would think it 6 would be within our bailiwick to understand some of the 7 behavioral issues on this particular issue. I think 8 there are some studies, although they may not be so 9 recent, but I think it’s probably -- and I think it 10 probably focuses on childhood; not only are there some 11 worrisome data issues showing in terms of the blood 12 pressure going up in childhood, but I think one of the 13 issues is how much of tracking is due, on a behavioral 14 basis, rather than on a physiologic, genetic basis. 15 And this could have essentially identifying those 16 individuals, which are really are not on the trajectory 17 with their blood pressure, but on the trajectory with 18 their sodium intake. And so I think -- I think that’s 19 one area that we could add to the literature. 20 I think the second issue of the implementation is 21 how well have we implemented the guidelines from 2005, 22 and particularly relative to the 1,500 target for high Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 219 1 risk groups. So how well have the African-Americans 2 and patients with congestive heart failure and 3 hypertension done, and I think there may be some 4 discouraging news there, but it also will tell us 5 perhaps something about implementing the Guidelines 6 this next time around, and I think it would -- I think 7 it would be useful to have those data, if in fact they 8 have been looked at. 9 Just a couple of other things, the -- I think we 10 shouldn’t forget about some of the other cadence, 11 particularly the diabetic ones. I don’t know -- is 12 calcium and magnesium the bailiwick of this, or some 13 other group? 14 DR. APPEL: I think that’s -- 15 DR. NICHOLS-RICHARDSON: That was my question too, 16 is where do you see fortified beverages, functional 17 food-type beverages? Do you see that in the nutrient 18 adequacy group, or do you see that in the beverage 19 group? How do you handle that? 20 DR. PEARSON: Those electrolytes, the last time 21 they worked. 22 DR. APPEAL: Yeah. That -- I mean, that’s -- Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 220 1 well, this is one of the problems we had in 2005, you 2 know? Because you can really, you know, you can put 3 these questions in different, in different subgroups. 4 I mean, the issue is nutrient adequacy, which is what, 5 you know, calcium and magnesium are. I mean that was 6 actually in the nutrient adequacy group. We didn’t 7 deal with that. I mean, there can be migration, you 8 know, in 2010, you know, to equalize work loads and 9 stuff like that. But, you know, I hadn’t been thinking 10 about calcium and magnesium in my group. I think we’d 11 also want to make sure we have the right expertise, and 12 I am not sure that -- you know, I think if we do some 13 switching, we might have to rearrange some of the 14 committees. 15 DR. NELSON: So, I have a question for you. This 16 is Mim Nelson. Regarding the relative benefits of 17 potassium alone versus fruits and vegetables as a 18 deliverer of potassium, and -- because we talked about 19 wanting to increase potassium. 20 DR. APPEL: Right. 21 DR. NELSON: And one of the worries I get, if we 22 focus just on potassium, we are going to get all the Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 221 1 food manufacturers just adding tons of potassium, and 2 there may be other issues that we are not aware of. 3 And so I -- but I don’t know this literature all that 4 well, but I just -- the relative different 5 contributions of fruits and vegetables, or you know, 6 fruits is -- 7 DR. APPEL: Yeah. 8 DR. NELSON: -- versus just potassium. 9 DR. APPEL: Okay. That’s a great question. I 10 think, just to again go back to 2005, I think if you 11 look at the rationale, you know, why we are 12 recommending large amounts of fruits and vegetables, it 13 actually was because of the potassium guideline, okay? 14 Because we didn’t really -- we didn’t -- I mean there 15 is some epidemiologic data dealing with fruits and 16 vegetables and stroke that we reviewed, which is good. 17 It was like about nine out of 10 studies at that time 18 showed that increased fruits and vegetables were 19 associated were reduced stroke. And there wasn’t that 20 much with CHD at that point. There has been an amended 21 analysis since then. So that fruit and vegetable 22 recommendation was driven not as much by cancer, as it Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 222 1 was to get your potassium up, okay? 2 DR. NELSON: Good. 3 DR. APPEL: In terms of its effect and are there 4 other nutrients, I guess I would go back to one of my 5 own studies, the DASH clinical trial. There was a 6 third arm, you know, a fruit and vegetable arm, and 7 then there was a third arm, the DASH diet. We got half 8 of your blood pressure effect with fruit and vegetable 9 and the half, and the further reduction of blood 10 pressure going from the fruit and vegetable to the DASH 11 diet. 12 DR. NELSON: Yes. 13 DR. APPEL: So there is something, you know, 14 something, probably some other things besides, you 15 know, potassium that are contributing to the blood 16 pressure reduction in this broad panel of nutrients, 17 and we probably won’t be able to figure it out. So, 18 you know. Yeah folate, that’s right. 19 DR. CLEMENS: Rog -- I appreciate your comment, 20 Tom, about the century characteristics of sodium and 21 sodium chloride, and to think back on what you said, 22 Mim, is that a factor? You just can’t arbitrarily add Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 223 1 potassium chloride to a product. It is extremely 2 bitter. So we have to leave some of the salts. If you 3 recall, after the 2005 and before that we tried to 4 replace sodium chloride with potassium chloride salts 5 and it was a dismal failure, because our palates said 6 this is not good for us. It is very bitter, so we have 7 to look at other alternatives. 8 DR. APPEL: But there are -- I am listing -- you 9 know, potassium citrate, potassium bicarbonate -- 10 DR. CLEMENS: Moderately different indeed. 11 DR. APPEL: Yeah. So I think, you know, that also 12 gets closer to the form of potassium that’s in fruits 13 and vegetables. And so, you know, I think that you can 14 really not make the case for potassium chloride, both 15 based on sort of that part -- actually primarily 16 because of the reason you said, but there is also a 17 good physiologic basis for doing, for thinking about 18 potassium citrate because, or bicarbonate because 19 that’s what, you know, if there is a benefit on 20 osteoporosis and kidney stones, it might be related to 21 the accompanying anion. 22 DR. VAN HORN: Tom. Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 224 1 DR. PEARSON: There has been some recent 2 prevalence estimates relative to chronic renal disease 3 that I think were surprisingly high. Is this an issue 4 with, also a vote against potassium supplement, where 5 you’d have a potential for actually getting people into 6 trouble? 7 DR. APPEL: Well, you know, the issue of potassium 8 in renal disease is pretty tricky, okay? And certainly 9 when people are close to renal failure, research into 10 potassium is important. But actually, you know, there 11 is a body of evidence that if people, you know the 12 potassium could protect the kidney, so it’s one of 13 those sort of interactions with level of kidney 14 function where it might be good for you, at some point, 15 and then bad for you at another point, and where that 16 flip occurs is not known, you know? And that’s 17 something actually we are investigating ourselves. 18 DR. PEARSON: Yeah. It may be something we should 19 look into. 20 DR. APPEL: Yeah. The only thing is, and I guess 21 this succumbs to some issues we have to decide, you 22 know where -- you know, I would hate for us to focus on Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 225 1 very important clinical populations, those with 2 advanced kidney function, you know, which I think is 3 probably beyond the bailiwick of what we were asked to 4 do. 5 DR. VAN HORN: I just would like to add a couple 6 of comments to that though, Larry. 7 DR. APPEL: Yeah. 8 DR. VAN HORN: For one thing, I think you know 9 some of the beauty of the DASH diet and the subsequent 10 premier diet, and you know all the diets that are sort 11 of focused on that approach, to me was the fact that 12 even normal tensive individuals lowered their blood 13 pressure with a diet like that. And so our guidelines 14 I think also will be expected to tell people what to 15 eat. And so the idea of telling people to eat more 16 fruits and vegetables as a source of these nutrients 17 represents not only the nutrient, but the company they 18 keep, and you know, the enhancement of let’s say, 19 again, this background diet that we are, you know, 20 presenting as a way to go ahead with this, as opposed 21 to a functional food with one nutrient that’s increased 22 that thereby could leave room for other adverse intake Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 226 1 of foods that we probably wouldn’t recommend. That’s 2 one thing. The other thing, I just have to comment, 3 because this whole discussion regarding sodium 4 sensitivity in terms of flavor and acquired taste is 5 very near and dear to my heart, because my doctoral 6 research was exactly on that subject, in a cross-over 7 design with high school kids in an in-dwelling 8 situation, and finding that after only four weeks of 9 being exposed to a diet that was lower in sodium -- and 10 I’m not talking extreme; I’m simply talking lower in 11 the sodium that they were eating -- they could not 12 return to the same level of sodium intake they had at 13 baseline. It was terrible in terms of the study 14 design, because it, you know, put people at a lower 15 level for the second phase, but the learning principle 16 behind that was phenomenal in that even in such a short 17 time, kids prevented from eating that much sodium and 18 increased in the fruits and vegetables couldn’t return 19 to that higher sodium intake, because it was 20 distasteful after that. So, I think there is again 21 this whole issue of learning preferences of foods and 22 flavor that, you know, is a whole area of research that Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 227 1 I know, you know, is emerging, but something that we 2 might want to take a look at. 3 The other last thing I’ll point out is, I don’t 4 think we have ever been in a situation as we are now 5 where we have so much sodium in the presence of rising 6 sugar intake, and you know the combination of more 7 sugar, more salt and whether or not that has any real 8 impact on our taste preferences and choice of foods, 9 and/or physiologic outcomes, you know, might be 10 something we’d want to consider as well. Just a 11 thought. Yeah, Eric. 12 DR. RIMM: Very good. I don’t remember where we 13 came in the last time, but are we going to revisit 14 anything with milk, or is milk a little bit also as a 15 calcium source? 16 DR. APPEL: That was dealt with in nutrient 17 adequacy. It’s funny, you know, this -- I, in terms of 18 like how things got covered, it was -- we didn’t say, 19 like have a subcommittee on dairy; we didn’t have a 20 subcommittee on meats. You know, we really sort of -- 21 you know, there really weren’t even specific questions 22 related, you know, to meats, and that may be, you know, Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 228 1 under some of the protein discussions, but we actually 2 have to, you know, figure out how we are going to, you 3 know, partition some questions that we really actually 4 haven’t come up with because it wasn’t under the 5 original set of subcommittees from last year or from 6 five years ago. So, I mean, I didn’t cover dairy, and 7 I don’t know if intrinsically nutrient adequacy would 8 have, but that’s the closest, you know -- it was the -- 9 I think it was saved under the calcium recommendation, 10 if I remember correctly? 11 DR. PEARSON: It was under nutrient adequacy. 12 DR. NICHOLS-RICHARDSON: It was under nutrient 13 adequacy. 14 DR. APPEL: Yeah. 15 DR. NICHOLS-RICHARDSON: It covered that as part 16 of the DASH diet and the eating plans with the Healthy 17 Index. 18 DR. APPEL: Yeah. 19 DR. RIMM: Right. 20 DR. SLAVIN: But what about if it’s blood pressure 21 related, does it go into your group then? 22 DR. APPEL: Well, you know, mine is fluid and Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 229 1 electrolytes. I don’t mind to be dealing with blood 2 pressure issues. It’s near and dear to my heart, on 3 blood pressure, but you know that’s -- you know, I can 4 certainly -- you know, I mean, for calcium though there 5 really is not a good story, and you know, magnesium 6 either. So, they are not going to drive decisions on 7 -- blood pressure effects are minimal and really would 8 not drive decisions. 9 DR. SLAVIN: But back to low-fat dairy within 10 DASH? 11 DR. APPEL: Again, the DASH actually happened at 12 the very end when it appeared that the diet met all of 13 the DRIs, and as well as had health effects just 14 happened to be DASH, okay? So we actually went through 15 a lot of a building process, and then we, at the end we 16 also had documentation, well here is the DASH diet, but 17 you know, this is with the nutrient profile of that 18 diet and it just happened it coincided very nicely, you 19 know, and it has biological effects as well as the 20 nutrient profile we were looking for. So that became a 21 vehicle to, for, for this committee, or for the last 22 committee, to say, yeah, you can -- here is a diet we Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 230 1 have -- it’s been described. We have a lot of 2 materials on it. You know, it’s a winner here. But we 3 really did not work from the DASH diet during the 4 process. You can correct me if I’m wrong, Xavier, but 5 that’s what I sort of sense, it was just sort of at the 6 last meeting or so, I said, yeah, it works out. 7 DR. VAN HORN: Much as I love this conversation 8 and the discussion is going really well, unfortunately, 9 we have to be out of here in about three minutes. So, 10 Mim, do you have one final comment you want to make? 11 DR. NELSON: I don’t think that we have -- because 12 a nutrient or a food group is related to a certain 13 disease, that doesn’t really dictate I think where it 14 needs to be. I think, because all the nutrients affect 15 many different chronic conditions. So, I just -- I 16 wouldn’t worry about it. I think that, you know, the 17 calcium vitamin, or rather, the calcium and magnesium 18 and dairy worked well on our committee for now. If 19 there is a reason to move it in the nutrient adequacy, 20 I just think -- there are so many instances in which 21 they go all over, so. 22 DR. NICHOLS-RICHARDSON: Nutrient adequacy will Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 231 1 have a BMI of about 30 by the time we are done. 2 DR. NELSON: Yeah, right. There you go. 3 DR. VAN HORN: I’d like to thank the Committee and 4 everyone in the audience, and everyone for being here 5 today for this wonderful discussion and a great launch 6 to this new Guideline Committee. And we’ll resume 7 tomorrow morning at 8:30. Thank you. 8 (Wherein, the meeting was concluded at 3:55 p.m.). 9 ***** 10 11 12 13 14 15 16 17 18 19 20 21 22 Capital Reporting Company www.CapitalReportingCompany.com © 2009 (866) 448 - DEPO Page 232 1 CERTIFICATE OF COURT REPORTER 2 I, NATALIA KORNILOVA, the officer before whom 3 the foregoing was taken, do hereby certify that the 4 following was taken by me by audio recording and 5 thereafter reduced to typewriting under my 6 direction; that said transcript is a true record of 7 the recording taken by me; that I am neither counsel 8 for, related to, nor employed by any of the parties 9 to the action in which this deposition was taken; and, 10 further, that I am not a relative or employee of any 11 counsel or attorney employed by the parties hereto, 12 nor financially or otherwise interested in the outcome 13 of this action. 14 15 16 NATALIA KORNILOVA 17 18 19 20 21