Estimating Dietary Intake of Substances in Food. Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA- 3. Food and Drug Administration, 5. Fishers Lane, Rm. Rockville, MD 2. 08. For questions regarding this document, please contact Hyoung Lee, 3. Updated phone: 2. Alison Edwards, 3. Updated phone: 2. Center for Food Safety and Applied Nutrition (CFSAN). Additional copies are available from: Office of Food Additive Safety, HFS- 2. Center for Food Safety and Applied Nutrition. Food and Drug Administration. Campus Drive. College Park, MD 2. Updated phone: 2. U. S. Department of Health and Human Services. Food and Drug Administration. Center for Food Safety and Applied Nutrition. August 2. 00. 6This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. This guidance, one in a series of Chemistry Guidance documents. Food and Drug Administration's (FDA's) pre- market approval processes for food and color additives require an estimate of the probable consumer intake of the additive to determine whether its use or presence in a food at a given concentration is safe. The basis for this requirement is expressed in the Federal Food, Drug and Cosmetic Act (hereinafter referred to as . Furthermore, FDA also considers consumer intake of contaminants that may be present in foods. Under Section 4. 02(a)(1)- adulterated food, a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health. The intent of this document is to provide an understanding of the databases and methodologies used by the Office of Food Additive Safety (OFAS) in FDA's Center for Food Safety and Applied Nutrition (CFSAN) to estimate consumer intakes, not only of food and color additives, but of ingredients generally recognized as safe (GRAS), and other substances (e. In general, the quality of data can be highly variable, method dependent, and lacking in precision. Impurities are substances that are unavoidably or unintentionally present in food. The procedures used to estimate intakes of impurities in food are essentially the same as those used for estimating intakes of ingredients. The practical difference between estimating intakes of impurities and ingredients is the derivation of the concentrations of these substances in foods. The different procedures used for estimating intake of ingredients and impurities will be discussed in the remainder of this document, with detailed examples in the Appendix. Estimates of intake of an ingredient or chemical constituent of food require two key pieces of information: (1) the concentration of the substance in a food, and (2) consumer intake of foods that will or might contain the substance. In dietary intake assessments, the concentration data used will depend on the nature of the specific intake assessment. The concentration of an ingredient or chemical constituent in food can be obtained from. However, in some cases, analytically- determined residues in the food may be used. For estimating intake of constituents in food ingredients. The concentrations of constituents in foods will generally fall on a distribution curve. The values falling below an analytical LOD are typically reported as . Therefore, recognizing that a contaminant is generally not distributed uniformly in a living organism can be critical for an intake estimate. That is, its concentration in plant roots or animal flesh may differ significantly from that in the leaves of the plant or the skin of the animal. OFAS estimates or determines the concentration of the contaminant in the edible portion(s) of the organism as prepared for consumption, for use in its intake estimate. There are a number of sources of data available to OFAS for use in estimating intake of substances in the diet. Although OFAS has not used such data, this method was recently used by researchers in Switzerland to quantify acrylamide intake. These surveys measure food intake by one or more methods: i. FFQ), and diet history. The DHQ has been used to provide estimates of long- term nutrient intake for purposes of investigating diet- health hypotheses. Data derived from dietary surveys usually include the amount and type of food consumed, the percentage of consumers (or . OFAS typically uses an eaters- only intake (i. At 1. 00% eaters, the eaters- only intake equals the per capita intake. The per capita (or total- sample) intake includes both eaters and non- eaters of the food (see discussion below in . The MRCA survey is described in further detail below. The USDA has surveyed food use by U. S. The surveys are popularly known as the . The earliest record of vegetarianism comes from Indus Valley Civilization EPA head Scott Pruitt has spent the last week insisting that the Trump administration never discussed climate change when debating the decision to withdraw from the. Further evaluation of the intake estimate at the 90 th percentile for the emulsifier was carried out using a Monte Carlo analysis. Lognormal distributions of the. NHANES became a continuous program in 1. Dietary supplement data are available in separate files. The MRCA's 1. 98. The survey, which relies on reporting of the number of eating occasions for a given food per day rather than the amount of food consumed, provided a means to determine 1. The survey data were recorded by a single member of each surveyed household, usually the female head. These data are sometimes referred to as . Annual disappearance figures for a food commodity can be divided by the national population and by 3. Disappearance data cannot be used to estimate intake for targeted sub- populations (e. The food industry also measures the disappearance of specific products, including ingredients, into the market. The National Academy of Sciences (NAS) has, on several occasions (the most recent being 1. These data were used to calculate the per capita intake for each substance. Anemia goes undetected in many people and symptoms can be minor. The symptoms can be related to an underlying cause or the anemia itself. Most commonly, people with.Because these NAS surveys enjoyed only a 6. Although the program has been revised many times over the years, it currently uses four regional sample collections (or market baskets) each year. The foods sampled in the TDS are representative of those commonly consumed in the U. S. The TDS diets are compiled from the same national food consumption data used by OFAS (i. USDA or DHHS), but they represent the total per capita consumption of all of the approximately 6,0. To derive the TDS diets, per capita consumption is first calculated for each survey food and each food is then assigned to the TDS food to which it is most similar (e. TDS food . Finally, the per capita consumption for all survey foods assigned to a given TDS food are summed to obtain the TDS consumption amount (e. TDS food . The use of biomarkers for estimating intake has been investigated for methyl mercury. The first is the daily intake of the foods in which the substance is used or can be found. The second is the concentration or use level of the substance in each food. Simple examples of intake estimates are provided under . In the early 1. 97. USDA Nationwide Food Consumption Survey (NFCS) and the MRCA Menu Census survey. In conjunction with the FDA, the NAS developed a model for estimating intake that combined the MRCA data with the USDA/NFCS information. The MRCA data provided information on the frequency of consumption of foods over a 1. USDA/NFCS data provided portion size information. Intakes derived from multiple- day surveys of individuals were considered more representative of long- term or chronic intake than single- day survey- derived estimates. The relationship of food- consumption frequency, portion size, and substance concentration data to the estimated daily intake (EDI) of a substance x for a single individual is captured in the following equation. F = Total number of foods in which substance . Estimates of intakes of substances by sub- populations identified as target populations are performed as required. For example, if OFAS were to assess the safety of a food containing a substance that showed toxic effects in pregnant animals, the food intake for women of child- bearing age would be used in the analysis. An intake estimate of a food ingredient or contaminant at a given percentile, based on consumption of a single food, reflects the consumption of that food by a sub- population, the . For representing the probable consumption pattern of a population during an extended period of time, OFAS uses food consumption data from a multi- day survey. In addition, for the estimate of chronic intake, the concentration values for the substance in food should reflect the levels likely to be found over time. A regulatory upper- use level can be used for an ingredient expected to be consumed at a relatively constant level over time. Also, OFAS might use an upper- use level rather than a typical or recommended level to avoid the possibility of underestimating the intake by individuals who frequently consume the product containing the ingredient or who prefer a brand of food formulated with the maximum permitted level of the ingredient. To estimate contaminant intake in these cases, food consumption from single eating occasions or from one- day food intakes would be used. Using the concentration of the contaminant from the high end of the distribution of measured levels ensures that the intake estimate associated with the risk assessment would be conservative for a . When food consumption data are not available, or are thought to be underreported in the surveys (e. Each assessment, however, uses a similar set of planning questions, and by addressing these questions the assessor will be better able to decide what is needed to perform the assessment and how to obtain and use the information required. A distribution of the intakes of all individuals in the target sub- population can then be constructed and used in the risk assessment. An example of food- intake summary data is presented in Table 1. Table 1 Percent eaters. Food Intake (Eaters- only)mean (g/p/d)9. Food A6. 52. 54. 5Food B2. If the concentration of substance . Table 2 Concentration (.
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