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A new approach for assessing the dietary exposure to food additives a

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Dee M. Graham Ph.D. , Lloyd J. Filer M.D. & Sanford W. Bigelow Ph.D. a

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Del Monte Foods Company , 2747 Hutchinson Court, Walnut Creek, CA, 94598

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University of Iowa, Pediatrics Department, Hospitals and Clinics , W131GH, Iowa City, Iowa, 52242 c

Phizer Inc. , 235 East 42nd Street, New York, New York, 10017 Published online: 29 Sep 2009.

To cite this article: Dee M. Graham Ph.D. , Lloyd J. Filer M.D. & Sanford W. Bigelow Ph.D. (1992) A new approach for assessing the dietary exposure to food additives, Critical Reviews in Food Science and Nutrition, 32:2, 157-160, DOI: 10.1080/10408399209527591 To link to this article: http://dx.doi.org/10.1080/10408399209527591

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Critical Reviews in Food Science and Nutrition, 32(2):157-160 (1992)

A New Approach for Assessing the Dietary Exposure to Food Additives Dee M. Graham, Ph.D. Del Monte Foods Company, 2747 Hutchinson Court, Walnut Creek, CA 94598

Lloyd J. Filer, M.D. University of Iowa Pediatrics Department, Hospitals and Clinics W131GH, Iowa City, Iowa 52242

Sanford W. Bigelow, Ph.D. Downloaded by [UQ Library] at 18:33 09 November 2014

Phizer Inc., 235 East 42nd Street, New York, New York 10017 ABSTRACT: By analyzing composite samples of brand name foods, a new method called the Dietary Exposure Assessment Method (DEAM), if found to be feasible, may provide useful estimates of daily intake of food additives for major portions of the U.S. population. KEY WORDS: composite samples, consumption estimates, daily intake, food additives survey, GRAS.

I. INTRODUCTION The public has been concerned about food safety for a long time. The recent episodes related to Alar-treated apples and cyanide-tainted Chilean grapes have served to increase consumer concerns. Improving food safety has great health and economic benefits for our society. Although the U.S. has one of the safest food supplies in the world, there has been increased public awareness of the potential health effects posed by foodadditive substances and contaminants. Unfortunately, sufficient information to make informed judgments about the safety of some of these substances is lacking in many instances. For the purpose of assessing the safety of food additives, there is an expressed need to acquire data on the dietary exposure to chemicals added directly to food, both regulated food additives and substances generally recognized as safe (GRAS). The safety evaluation of GRAS and "prior-sanctioned" substances was initiated in 1970 as a priority established by a presidential directive of 1969. This process has continued with the ongoing Priority-Based Assessment of Food Additives Review Program in the Food and Drug Administration (FDA). The initial approach

1040-8398/92/$.50 © 1992 by CRC Press, Inc.

involved completion of a complex questionnaire on food additive use by food processors and food chemical producers. Exposure has been estimated periodically since 1971, using national surveys of annual poundage conducted by the National Research Council's Committee on Food Additives survey data.6""8 Initially the survey data were used to determine trends in usage and hence probable exposure to specific food additives. Coupled with population data, frequency of eating data, use levels, portion sizes, and diet histories, estimates of individual intakes have been calculated.1 To make the trend lines meaningful, a concept of matched poundage was used in successive surveys.13'14 As the rate of organizational changes has accelerated recently in the food industry, new products have appeared and old ones have disappeared. The ability to match usages in successive 5-year surveys has been virtually lost. In 1989, the Committee on Food Additive survey data concluded that the matched-poundage concept could not be used for another survey. Therefore, new approaches to the existing methods were needed for assessing dietary exposure to food additives. Here we offer a new approach, called the Dietary Exposure Assessment Method

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(DEAM), that, if feasible, should provide per capita consumption estimates of dietary exposure to food additives for major portions of the U.S. population.

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II. THE CONCEPT OF THE METHOD The method was conceived by the authors reflecting on questions raised by the Committee on Food Additives survey data about the validity of the matched-poundage analysis data. Review during its evolution by members of the Food and Nutrition Board, the International Life Sciences Institute Committee on Macronutrient Substitution, and several other participants in national food and food chemical surveys contributed significantly to address the validity and feasibility of this method. With this background, we have conceived and proposed a new methodology to update the data base on food-additive intake. The concept of the method is as follows: Directly measure the level of food additives in a composite sample of foods that has a known level of consumption. The proposed method combines some elements used in other surveys, such as the Total Diet Study,11'12 the Second National Health and Nutrition Examination Survey (NHANES II),4-5 the National Food Consumption Survey,2-3 GRAS affirmation process, and the National Academy of Science Food Additives Surveys.6-9-10 The method is based on the following key steps: 1. 2. 3. 4.

5.

Select several food additives for analysis. Select a diet containing foods with available market-share data. Purchase and prepare brand name food products representing that diet. Combine the portions to produce a composite food sample, based on market-share rank, that represents food intake for 1 d. Analyze for the level of specific additives in the composite food sample.

ing the feasibility of the method, we have suggested the use of one mainstream eating pattern of one age-sex group identified in NHANES II12 with three composite samples of food products combined by their market-share rank as shown in Table 1. Thus, the three composite samples will contain the top, second, and third market shares. Each sample would comprise 20 food products. We estimate such an analysis would measure almost 40% of the total diet in this agesex group based on findings from the NHANES H4-5 and the 234 foods analyzed in the Total Diet Study.11 A more comprehensive study might also examine the seven remaining age-sex groups identified in the Total Diet Study12 as well as in the recommended dietary allowances,10 and would provide a total of eight composite samples, including 300 foods accounting for about 84% of the total diet.11 Other eating patterns and constituent foods could be chosen to fit the specific objectives of more specialized surveys. Several problems are listed in Table 2 that must be addressed by users who decide to execute the DEAM. Cost, availability of funding, and capacity for data analysis are major factors to be considered in determining the size and breadth of such a study.

IV. DISCUSSION The utility of this new approach is obvious. The basic methodology of using direct laboratory analysis of specific foods in lieu of broad industry surveys of usage should provide more accurate estimates. The use of composite samples greatly expands the scope of foods that can be evaluated with a reasonable number of analyses. Thus, the number of analyses is manageable, even if more than one food additive is measured for each technical effect.7 The composite sample and selection of the analyte can be tailored to the specific objective, which needs to be developed carefully before any sampling is done. The factors essential to use this method are

III. AN EXAMPLE OF THE METHOD • For a preliminary broad-scale survey of foodadditive exposure with the purpose of determin-

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A basis for selecting the diets and portion sizes. Analytical methods to recover the target

TABLE 1 Hypothetical Eating Pattern Number One (Hypothetical Brand Name Foods for the Three Composite Samples)*

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Food Product Orange juice Bread Milk Corn flakes Canned peaches Green beans Toast Coffee Cola Hamburger French fries Catsup Spaghetti Salad Margarine Lemonade Cherry pie Ice cream Cookies Potato chips

Composite No. 1

Composite No. 2

Composite No. 3

Minute Maid Wonder Sealtest Kellogg's Del Monte

Citrus Hill Wholesome Meadow Gold Nabisco Libby

Tropicana Keebler H. P. Hood Post Towne House

Del Monte Wonder Maxwell House Coca-Cola McDonald's McDonald's Heinz Franco-American Fresh Kitchen Fleishman's Minute Maid Sara Lee Borden's Oreos Frito-Lay

Green Giant Wholesome Hills Bros. Pepsi Cola Burger King Ore-Ida Hunts Hormel Cut-N-Ready Blue Bonnet Tropicana Mrs. Smith's Meadow Gold Mother's Wise

Lucerne Schmidt Folgers RC Cola Wendy's Heinz Del Monte Chef Boy-ar-dee Contadina Shedd's Spread Country Tyme Swiss Miss Breyers Almost Home Cains

Mention of these brand name food products in this table does not necessarily indicate their market share rank, but they are used in an effort to illustrate the potential feasibility of the DEAM.

TABLE 2 Issues to be Resolved Related to the Dietary Exposure Assessment Method Identifying the most appropriate additive for analysis Selecting suitable diets for the intended purposes of the survey Choosing the most appropriate age-sex group for determining dietary intake Choosing portion sizes that reflect what is actually consumed, not what is served How to handle seasonal differences in diets Determining the amount of composite sample that should be prepared Choosing an adequate organization to select, purchase, and prepare the foods for the composite diets Refereeing the analytical results among laboratories, because all assays are unlikely to be conducted in the same laboratory Safeguarding confidential market-share data Choosing the best method and site for storage of the composite sample Choosing a data processing system adequate for storage and retrieval of the data, as well as handling computer simulation studies without altering the analytical data base The need to deal with "outlier" diets (e.g., 99th percentile frequency of eating an unusual food) will be missed by this method Intra- and interlaboratory variability of analytical results Regional and seasonal differences in food consumption

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substance(s) from a complex matrix, as diluted by composite sampling. Long-term storage of the composite sample, e.g., frozen in liquid nitrogen, for subsequent analyses. Data entry and storage for computer simulation. Access to confidential market-share data if mainstream diets are used to reflect a national sample.





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We believe DEAM, as proposed here, can greatly improve the accuracy of food additive intake estimates. This method is needed for continuing reassessment of the risks associated with food chemicals. The method was conceived for estimating intake of food additives; however, other potential uses include estimating exposure to environmental chemicals (e.g., lead), nutrientintake data (e.g., underconsumption of starches, overconsumption of fats, or the nutritional impact of macronutrient substitutes), and pesticide residues (e.g., ethylene bisdithiocarbamates) in the food supply. Direct applications of DEAM to regulatory arenas include monitoring of dietary exposure to food additives and pesticides by the FDA and the estimation of exposure to potential toxicants as required by the State of California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

REFERENCES 1. Filer, L. J., Jr., Patterns of consumption of food additives, Food Tech., July, 62, 1976. 2. US DA nutrient data base for household food use surveys, NTIS No. PB82-138496, Consumer Nutrition Division, Human Nutrition Information Service, U.S. Department of Agriculture, Springfield, VA, 1982.

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3. USDA nutrient data base for individual food intake surveys, NTIS No. PB82-138504, Consumer Nutrition Division, Human Nutrition Information Service, U.S. Department of Agriculture, Springfield, VA, 1982. 4. U.S. Department of Health and Human Services and U.S. Department of Agriculture, Nutrition monitoring in the United States — a report from the joint nutrition monitoring evaluation committee, DHHS Publication No. (PHS) 86-1255, Public Health, U.S. Government Printing Office, Washington, D.C., July 1986. 5. Life Sciences Research Office, Federation of American Societies for Experimental Biology, Nutrition monitoring in the United States — an update report on nutrition monitoring, DHHS Publication No. (PHS) 89-1255, Public Health, U.S. Government Printing Office, Washington, D.C., September 1989. 6. National Research Council, Committee on Food Consumption Patterns, Assessing changing food consumption patterns, National Academy Press, Washington, D.C., 1981. 7. National Research Council, Committee on Food Additives Surveys, 1982 poundage update of food chemicals, NTIS No. PB84-162148, February 1984. 8. National Research Council, Coordinating Committee on Evaluation of Food Consumption Surveys, National survey data on food consumption: uses and recommendations, National Academy Press, Washington, D . C , 1984. 9. National Research Council, Committee on Food Additives Surveys, 1987 poundage update of food chemicals, NTIS No. PB84-162148, 1984. 10. National Research Council, Subcommittee on the Tenth Edition of the Recommended Dietary Allowances, recommended daily allowances, tenth edition, National Academy Press, Washington, D . C , 1989. 11. Pennington, J. A. T., Revision of the Total Diet Study food list and diets, J. Am. Dietetic Assoc., 82, 166, 1983. 12. Pennington, J. A. T. and Gunderson, E. L., History of the Food and Drug Administration's Total Diet Study — 1961 to 1987, J. Assoc. Off. Anal. Chem., 70, 772, 1987. 13. Rehwoldt, R. E., Tracking the use of antioxidants through industry surveys, Food Chem. Toxicol., 24, 1039, 1986. 14. Rehwoldt, R. E. and van der Have, R., Identifying trends in food chemical usage, Food Tech., April, 102, 1986.

A new approach for assessing the dietary exposure to food additives.

By analyzing composite samples of brand name foods, a new method called the Dietary Exposure Assessment Method (DEAM), if found to be feasible, may pr...
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