Apri! 1998: S5-S9 Process and Development of Dietary Reference Intakes: Basis, Need, and Application of Recommended Dietary Allowances Allison A. Yates Dr. Yates is Director of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences, Washington, DC 20418, USA. Nutrition Reviews, Vol. 56, No. 4 sentation from Canadian scientists, a set of dietary reference intakes, which will include estimated average requirements (EARS),RDAs for individuals, and tolerable upper limits of intake (ULs). The report on the first group of nutrients (calcium, phosphorus, magnesium, vitamin D, and fluoride), to be evaluated under the expanded framework, is expected to be issued in late spring 1998. Note added in proo$ This report was issued in August 1997 and included an additional recommended intake level, adequate intake (AI). Overview NAS is a nonprofit, private, honorific organization chartered by the US Congress in 1863 to provide nonbiased analysis of scientific issues of interest to the federal government. The FNB, since it was formed in 1940 as aunit of the National Research Council of the NAS, has periodically reviewed the scientific literature and provided guidance to the federal government and others about dietary recommendationsand issues of nutrition, food safety, and health. Since 1990the FNB has been a division of the Institute of Medicine, which operates as an arm of NAS. In 1941, when first established, the RDAs of the FNB were based partially on a few experimentally determined nutrient requirements but primarily on observations of nutrient intakes from usual food patterns that appeared to be adequate for maintaining health and preventing known deficiencies. They were established as a goal for good nutrition and a yardstick to measure progress.’ In the last three editions of the RDAs, the working definition of the RDAs has been the “levels of intake of essential nutrients considered, in the judgment of the FNB on the basis of available scientific knowledge, to be adequate to meet the known nutritional needs of practically all healthy persons.”24The first recommendations,in 1941, were for energy; protein; calcium; iron; vitamins A, C, and D; thiamin; riboflavin; and niacin. Over the years, additional nutrients have been added, so that the 10th edition4 contained recommendations and safe intakes for 26 nutrients plus energy (Figure 1). These recommendationshave been developed by noted nutrition scientists brought together by NAS and as such represent quantitative advice s5 Downloaded from http://nutritionreviews.oxfordjournals.org/ by guest on May 12, 2016 Since 1940,the Food and Nutrition Board of the National Academy of Sciences of the United States (NAS) has developed and periodically published recommended dietary allowances (RDAs). RDAs have been used as the scientific basis for federal nutrition and food policy in the United States. When first developed, RDAs were intended as allowances that would meet the nutritional needs of most healthy people; they were designed for planning diets to prevent nutrient deficiencies in groups. They have come to be used for many other purposes, such as food labeling and food selection guides for healthy diets; they are the basis of assessment of the adequacy of dietary intakes in national surveys, and they serve as the basis for food security programs such as food stamps and supplemental foods provided to low-income citizens. As scientific knowledge about diet and health has increased, technology has improved to allow measurement of small changes in individual adaptation to consumption of various levels of nutrients. Chronic diseases or conditions that had been difficult to ascribe to inadequate or excess consumption of a specific nutrient have been found to be closely linked to diet or nutrient intake. To include these possible relationships in the definition of “adequacy” used to establish dietary allowances, the NAS Food and Nutrition Board (FNB) has expanded its framework for determining dietary allowances. Also, because of increased consumption of nutrients in concentrated form, either singly or in combination with others outside of the context of food, and because of the use of fortification or enrichment of foods, the FNB is also examining data regarding the extent to which excess nutrient intakes increase the risk of adverse or toxic effects. Thus, where adequate data are available, a reference intake level considered “safe” will be established. The FNB has been reviewing these issues since 1991 and is currently in the process of developing, under an expanded framework that will be described and with repre- Recommended Dietary Allowances 1989 0 Energy 0 Protein 0 7 minerals (Ca, Fe, @ 0 Mg, Zn, I , Se) 11 vitamins (A, C, D, B,, B, niacin, E, K, B,, B,*,folate) Safe and adequate daily dietary intakes (biotin, pantothenate, Cu, Mn, F, Cr, Mo) Figure 1. RDAs 1989. Examples of Application of RDAs Users: Government-lndustry-AcademiaHealth Services Uses: Guide for procuring food supplies for groups of healthy persons Basis for planning meals for groups Reference point for evaluating the dietary intake of population subgroups Component of food and nutrition education programs Reference point for the nutrition labeling of food and dietary supplements Figure 2. Examples of application of RDAs. S6 Nutrition Reviews, Vol. 56, No. 4 Downloaded from http://nutritionreviews.oxfordjournals.org/ by guest on May 12, 2016 to professionals about the amounts of nutrients thought adequate for almost all of the population group for whom they are intended. Dietary guidelines within the United States represent qualitative advice to the public about diet and prevention of chronic d i ~ e a s eWithin .~ the United States and Canada, dietary guidelines have-been based on recommended nutrient intakes. Over the years, because of the need to have some basis for dietary planning and assessment, the RDAs have been applied in a number of instances (Figure 2). They are currently used as the basis or guide for procuring food supplies for groups of healthy people, such as the miliin supplemental feeding programs for at-risk groups;' as the basis for planning meals for groups; as the reference point for evaluating the dietary intake of population subgroups; as the scientific basis for food and nutrition education programs such as the US Department of Agriculture food guide pyramid; and as a reference point for nutrition labeling of food and dietary supplements. Although the RDAs have been considered primarily as recommendations for preventing deficiency states, as new information has become available various editions of the RDAs have included statements about nutrient intake and decreasing the risk of various chronic diseases. For example, recommendations published in 1968 discussed the relationship of dietary fat and cardiovascular disease,* whereas recommendations published in 1974 stated that individuals at risk for coronary heart disease should follow the American Heart Association dietary recommendations for fat intake? As scientific knowledge about diet and health has increased, other chronic diseases or conditions that had been difficult to ascribe to inadequate or excess consumption of a specific nutrient have been found to be linked to diet or nutrient intake. In previous FNB publications? as in other major reports about the relationship between diet and health,1° the conclusions are based on varied data that typically include observed intakes in healthy populations, epidemiologic observations, balance studies, depletiodrepletion studies, and dose responses over time. The following criteria for causal relationships have be& well de~cribed:~J' Strength of association. Dose-response relationship. Temporally correct association. Consistency of association. Specificity of association. Biologic plausibility. Given individual variability in response and the length of time necessary to see measurable responses due to long-term intakes, it is often difficult to obtain scientific agreement about the quantitative relationships. To propose that these relationships be included in the definition of adequacy used to establish RDAs, the FNB released for comment an expanded framework for approaching the determination of dietary allowances.12This was a result of asking the nutrition and scientific community for comments on the following key questions: What factors limit the usefulness of RDAs in their current form? What new information exists that argues for a change from current values? Should concepts of disease prevention be included in the RDAS? How shouldrecommended levels be expressed?As single numbers? As ranges? Should toxic levels be included? Shouldthe RDAs deal with nutrient-nutrientrelationships? Are there new food components that should be considered? As a result of the comments received on the expanded p Safe range of intake X -- Os 9. Observed levelof intake Figure 3. Model for DRIs. Nutrition Reviews, Vol. 56, No. 4 Current Status of DRI Activity The FNB has been reviewing these concepts since 1991, in part on the basis of the most recent Dietary Reference Valuesfor Food Energy and Nutrientsfor the UnitedKingdom.l4 Under the expanded framework described here and with representation from Canadian scientists, the first set Increasingintake 2SD . Recommended Dietary Allowance (RDA) EstimatedAverage Requirement (EAR) Figure 4. Model for dietary reference values. s7 Downloaded from http://nutritionreviews.oxfordjournals.org/ by guest on May 12, 2016 framework, the FNB has developed an expanded process for developingdietary recommendations. Where adequate data exist, the reductions of risk of chronic disease and developmental abnormalities are incorporated. Thus, a review of food components that may not meet typical criteria for essential nutrients, but for which there may be a beneficial effect on health, is also included. To be more responsive to the various uses to which past RDAs have been applied, multiple reference levels are provided. The overall process is called dietary reference intakesfDRIs). DRIs include at least three reference points (Figure 3): EAR, RDA, and UL. EAR is the average requirement for healthy individuals in which a functional or clinical assessment has been conducted and measures of adequacy have been made at a specified level of dietary intake. The data available are limited because few human studies have been done, particularly in population groups such as children and the elderly. EAR is the amount of intake of a nutrient at which about one-half of subjects would have their needs met and one-half would not. It must be stressed that the most important component of this analysis is the determination of “Adequate for what?’ This point is often ignored in discussions of dietary recommendations,but it is fundamental to subsequent uses of the estimate. It involves being able to ascertain for a given intake a marker or indicator of adequacy that is sensitive to the dietary intake over a reasonable time and that is directly related to a specific outcome by virtue of meeting the criteria for diet and disease relationships indicated above. Thus, for example, if a minimum amount of hemoglobin is considered to be the cutoff for adequacy, it should be related to a functional outcome, such as anemia, which results from an inadequate supply of oxygen to tissues because of a lack of red blood cells or hemoglobin. It is thus possible to have a number of indicators of adequacy, each of which may be related to one functional outcome (for example, red blood cell count versus hemoglobin content or packed cell volume) just as it is possible to have more than one functional outcome (anemia versus a minimum amount of iron stored as measured by total iron binding capacity). It is necessary first to obtain the scientific judgment of experts to determine the best indicators of adequacy for each defined level of nutriture and then to determine which level ofaxutrhre is most appropriate to use, assuming good health is the desired outcome. Once the EAR is determinedand some estimate of the variation in requirements is made (from experimental evidence or from interpolation of other data), a second reference intake is develope-he RDA, which is defined as the amount needed to meet the requirements of nearly all (97-98%) of the healthy population of individuals for whom it is developed. To calculate the MIA, the EAR is increased by 2 standard deviations (or twice the coefficient of variation) of the estimated average requirement (Figure 4).The RDA should serve as a goal for intake for individuals. It should not serve as the benchmark of adequacy in the diets of populations, which is often a misuse of numbers derived in the past. The EAR has been proposed to be used as the basis for assessing populations once knowledge of the variation in intake among the population is included in the ana1y~is.I~ Thus, although the EAR is not used as a reference intake for individuals, its two purposes are to develop a reference intake to serve as a goal for an individual (RDA) and a reference intake with which to assess a population’s intake. Because of increased consumption of nutrients in concentrated form, either singly or in combination with others outside of the context of food, and because oflhe increased use of fortification or enrichment of foods, the FNB has also included in the framework a model for examining the data regarding the extent to which excess nutrient intakes increase the risk of adverse or toxic effects. Thus, where adequate data are available, a reference intake level for safety will be established-the UL. nents (Figure 5). It is hoped that, as funding becomes available, the subcommittee on applications and uses of DRIs will be able to start work to provide guidance scientifically valid uses of the various DRIs in both assessment of the diets of populations and in the use of DRIs as goals in population-based dietary guidelines. Note added in proofi The folate and B vitamins report will be released in April 1998. A new panel to look at dietary antioxidants and related compounds has been named, and its report is expected in fall 1998. National Research Council. Recommended dietary allowances. Washington, DC: National Academy Press, 1941 2. National Research Council. Recommended dietary allowances, 8th ed. A report of the Committee on Dietary Allowances and Committee on Interpretation of the Recommended Dietary Allowances, Food and Nutrition Board. Washington, DC: National Academy Press, 1974 3. National Research Council. Recommended dietary allowances, 9th ed. A report of the Committee on Dietary Allowances, Food and Nutrition Board. Washington, DC: National Academy Press, 1980 4. National Research Council. Recommended dietary allowances, 10th ed. A report of the Subcommittee on the Tenth Edition of the RDAs, Food and Nutrition Board. Washington, DC: National Academy Press, 1989 5. US Department of Agriculture, Agricultural Research Service, Dietary Guidelines Advisory Committee. Report of the Dietary Guidelines Advisory Committee on the dietary guidelines for Americans, 1995, to 1. - Committee on Dietary Reference Intakes Other food components Panel Figure 5. DRI framework of panels. S8 Nutrition Reviews, Vol. 56, No. 4 Downloaded from http://nutritionreviews.oxfordjournals.org/ by guest on May 12, 2016 of DRIs should be completed by late 1997.This report will include EARS,RDAs for the individual, and ULs. The project has been organized into two subcommittees and seven panels of nutrient experts under the oversight of the Standing Committee on Dietary Reference Intakes of the FNB (Figure 5 ) . The standing committee has nine members, with a nonvoting liaison from the govemments of the United States and Canada. To develop scientific bases for all reference intakes, many experts will be involved; assuming there is adequate funding from both public and private organizations, the project will take at least 4 years. One subcommittee, which is composed of nutritionists, clinicians, and toxicologists, has been given the task of developing a model for risk assessment of high intakes of nutrients; it will review the adverse effects of high levels of intake of each nutrient or food component according to the model that is developed and will derive appropriate limits of intake. The panel on calcium and related nutrients (the first group of nutrients to be reviewed includes calcium, phosphorus, magnesium, vitamin D, and fluoride), which is composed of 10 experts, was scheduled to com>lete its work in early spring 1997, and the report issued by the DRI committee was scheduled for late spring. A second panel-the panel on folate, vitamin B12,vitamin B,, other B vitamins, and choline-has been named and will develop the basis for DRIs for those nutrients, with a report to be issued in spring 1998. Five other panels will be appointed, one of which will focus on other food compo- 10. US Department of Health and Human Services. The 11. 12. 13. 14. surgeon general’s report on nutrition and healthDHHS (PHS) PublicationNo. 88-50210. Washington, DC: US Government Printing Office, 1988 Hill AB. Principles of medical statistics, 9th ed. New York: Oxford University Press, 1971 Instituteof Medicine, Food and Nutrition Board. How should the recommended dietary allowances be revised? Washington, DC: National Academy Press, 1994 Beaton GH. Criteria of an adequate diet. in: Shils RE, Olson JA, Shike M, eds. Modern nutrition in health and disease, 8th ed. Philadelphia: Lea & Febiger, 1994;1491-I 505 Committee on Medical Aspects of Food Policy. Dietary reference values for food energy and nutrients for the United Kingdom. Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy. Departmentof Health, Report on Health and Social Subjects, No. 41 London: HMSO, 1991 The Food and Nutrition Board Standing Committee on the Scientific Evaluation of Dietary Reference Intakes is chaired by Vemon R. Young (Massachusetts Institute of Technohogy); cochaired by John W. Erdman, Jr. (University of Illinois at UrbanaChampaign) and Janet C. King (USDA Western Human Nutrition Research Center); and includes Lindsay H. Allen (University of California, Davis), Stephanie A. Atkinson (McMaster University), Johanna T. Dwyer (Frances Stem Nutrition Center), John D. Femstrom (University of Pittsburgh School of Medicine), Scott M. Grundy (University of Texas Southwestern Medical Center at Dallas), and Sanford A. Miller (University of Texas Health Science Center). The senior staff for the Institute of Medicine (IOM) include Allison A. Yates, Project Director, Carol W. Suitor, and Sandra A. Schlicker. For further information, write FNB/IOM, 2101 Constitution Avenue, NW, Washington, DC 20418, or e-mail at [email protected]. Nutrition Reviews, Vol. 56, No. 4 - s9 Downloaded from http://nutritionreviews.oxfordjournals.org/ by guest on May 12, 2016 the Secretary of Health and Human Services and the Secretary of Agriculture. Washington, DC: US Government Printing Office, 1995 Institute of Medicine, Food and Nutrition Board Committee on Military Nutrition Research. Nutritional needs in cold and high altitude environments. Washington, DC: National Academy Press, 1996 Institute of Medicine, Food and Nutrition Board, Committee on the Scientific Evaluation of WIC Nutrition Risk Criteria. WIC nutrition risk criteria, a scientific assessment. Washington, DC: National Academy Press, 1996 National Research Council. Recommended dietary allowances, 7th ed. A report of the food and Nutrition Board, Publication No. 1694. Washington, DC: National Academy Press, 1968 National Research Council. Diet and health: implications for reducing chronic disease risk. A report of the Committee on Diet and Health, Food and Nutrition Board. Washington, DC: National Academy Press, 1989
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