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The Exposure Assessment for Acrylamide Donna Robie, Ph.D. and Michael DiNovi, Ph.D. Office of Food Additive Safety February 24, 2003.

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Presentation on theme: "The Exposure Assessment for Acrylamide Donna Robie, Ph.D. and Michael DiNovi, Ph.D. Office of Food Additive Safety February 24, 2003."— Presentation transcript:

1 The Exposure Assessment for Acrylamide Donna Robie, Ph.D. and Michael DiNovi, Ph.D. Office of Food Additive Safety February 24, 2003

2 History and Background Sweden – April 2002 About 100 Food Samples Total Used Medians for 8 Food Categories Estimated Mean Exposure to Acrylamide 40 µg/person/day (0.67 µg/kgbw-day, 60 kg bw/person) Included “Expected” Value for Food Groups Not Covered in their Sampling

3 FAO/WHO – June 2002 Used the Same Residue Data as Sweden Used food consumption data from U.S., the Netherlands, Norway, Australia, Sweden, and from IARC EPIC Study Used Probabilistic Modeling as well as Point Estimate Methods Long-Term Exposure Estimates 0.3 - 0.8 µg/kgbw-day History and Background

4 EDI x = The Estimated Daily Intake of Substance x F = Total no. of foods in which x can be found Freq f = No. of eating occasions for food f over N survey days Port f = Average portion size for food f Conc xf = Concentration of the substance x in the food f N = No. of survey days Exposures for Individuals Combined Simplified Exposure Equation

5 Food Consumption Surveys CSFII –Continuing Survey of Food Intakes by Individuals Three-day Consumption Records; 1989-1992 Two-day Consumption Records; 1994-1996, 1998 Approximately 20,000 participants Intakes of Eaters Overestimated and Percent Eaters Underestimated, Relative to Intake Records Obtained During a Longer Survey Period

6 Food Consumption Surveys MRCA - Marketing Research Corporation of America Fourteen-day Consumption Records; 1982–1987 Approximately 26,000 participants Census of Frequency of Eating Linked with Portion Size Data from USDA/Nationwide Food Consumption Survey

7 Future – Chronic Intake Modeling CSFII 1994-96, 98, 2-Day Survey Data Better Estimate of Chronic Exposure with Longer- Term Survey Data Adjusting 2-Day CSFII Survey Data Broadening the Distribution to Include More Eaters Reducing the Food Consumption Distribution Mean Total Population Food Consumption Kept Constant

8 Simple Exposure Estimate Simplest Model EDI = Σ [Food Consumption x Conc. of Substance] Summed over Foods Summed over Individuals Point Estimates Useful for Substances in Only a Few Foods Used When EDI and ADI/TDI (Acceptable Daily Intake/Tolerable Daily Intake) are Very Different

9 Probabilistic Modeling Distributions Used in Place of Point Estimates Food Consumption Typically Lognormal Concentration Data Determined Experimentally Percentage of Consumers Food Surveys

10 Probabilistic Modeling Iterative Process Computer Generated Each Iteration Contains Values for Food Consumption, AA level, and Percentage of Eaters Chosen from their Underlying Distributions

11 Monte Carlo Sampling 0 1 Food Consumption Cumulative Probability Distribution Random Number from Anywhere on y-axis Generated Value

12 Acrylamide Intake Modeling AA Intake = (Eaters (yes or no) ) x (Food Amt.) x (AA Level) Eaters (yes or no) – Either 0 or 1 in Proportion to Percent Eaters Food Amount – Food Consumption Value from Survey Data Acrylamide Level – Value from Laboratory Data – Each Value Equally Likely on Each Iteration Results are Summed over Foods and Individuals

13 Acrylamide Intake Modeling Food% Eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eater AA Intake (µg/kgbw-d) Almonds00.1457.00.00 AA Intake for Eater (µg/kgbw-d) Bagels00.211.80.00 Baked Beans11.970.00.13 Breaded Chicken01.235.00.00 0.50 Breaded Fish00.630.00.00 Breakfast Cereal00.41056.90.00 Brewed Coffee10.8184.50.14 … ……… …

14 Acrylamide Intake Modeling Each Iteration is a Virtual Consumer 25,000 Iterations No Accounting for Correlations Between Food Choices Truncation of Distributions Removes Irrationally High Values 13 L of Coffee Per Day – 100 th Percentile 620g of Cookies per Day – 100 th Percentile

15 Model Limitations Surveys Duration Food Classifications Laboratory Data Some Food Types Represented by Fewer than Five Samples Variability in AA Levels Lot–to-Lot Brand-to-Brand Product-to-Product Foods Prepared at Home

16 Factors Applied to Food AA Concentration Ground Coffee/24 = Coffee as Consumed (Experimentally Derived) Instant Coffee Crystals/60 = Instant Coffee as Consumed (3g Coffee/6oz Cup) Dry Soup Mix/12 = Soup as Consumed (15g Soup Mix/6 oz Cup) Dry Cocoa Powder/10 = Cocoa as Consumed (17g Cocoa Powder/6oz Cup)

17 All Tested Foods Food Mean Population AA intake (ug/kgbw-d) Cumulative Percentile French Fries (RF)0.05615 French Fries (OB)0.04927 Brewed Coffee0.04739 Breakfast Cereal0.04451 Potato Chips0.04161 Cookies0.04072 Toast0.02378 Soft Bread0.02083 Food Mean Population AA intake (ug/kgbw-d) Cumulative Percentile Corn Snacks0.01186 Crackers0.00888 Pretzels0.00890 Popcorn0.00692 Baked Beans0.00693 Breaded Chicken0.00594 Peanut Butter0.00496 Soup Mix0.00396

18 All Tested Foods Food Mean Population AA intake (ug/kgbw-d) Cumulative Percentile Cocoa0.00297 Crisp Bread/Matzo 0.00297 Instant Coffee0.00298 Bagels0.00298 Chocolate0.00299 Tortilla0.00299 Breaded Fish0.001100 Food Mean Population AA intake (ug/kgbw-d) Cumulative Percentile Doughnuts0.001100 Almonds0.000100 Nuts & Seeds0.000100 Taro0.000100 Soy Protein0.000100 Pork Rinds0.000100 Malted Drinks0.000100 Total0.37

19 Acrylamide Intake MRCA 1982-87; 2+ Population Food % eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) Breakfast Cereal77.40.84133.30.110.09Mean AA Intake of Population (µg/kgbw-d) Potato Chips75.80.17548.00.090.07 Toast27.01.14207.80.240.06 French Fries (RF)48.90.35321.80.110.06 0.48 French Fries (OB)20.60.35663.80.230.05 Cookies66.50.27221.60.060.04 Soft Bread73.01.1444.40.050.04 Brewed Coffee57.54.808.50.040.02

20 Acrylamide Intake CSFII 1989-92; 2+ Population Food % eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) Breakfast Cereal46.60.66133.30.090.04Mean AA Intake of Population (µg/kgbw-d) Potato Chips18.00.38548.00.210.04 French Fries (RF)19.40.60321.80.190.04 French Fries (OB)8.80.58663.80.380.03 0.32 Toast35.00.45207.80.090.03 Cookies28.60.48221.60.110.03 Brewed Coffee47.27.318.50.060.03 Soft Bread68.00.7244.40.030.02

21 Acrylamide Intake CSFII 1994-96, 1998; 2+ Population Food % eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) French Fries (RF)19.00.91321.80.290.06Mean AA Intake of Population (µg/kgbw-d) French Fries (OB)8.00.91663.80.610.05 Breakfast Cereal40.80.81133.30.110.04 Potato Chips17.20.44548.00.240.04 0.37 Cookies30.60.59221.60.130.04 Brewed Coffee45.77.628.50.060.03 Toast22.40.49207.80.100.02 Soft Bread59.40.7844.40.030.02

22 Acrylamide Intake MRCA 1982-87; 2-5 Population Food % eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) Breakfast Cereal97.22.27133.30.300.29Mean AA Intake of Population (µg/kgbw-d) Potato Chips82.90.40548.00.220.18 French Fries (OB)30.70.80663.80.530.16 Toast29.02.63207.80.550.16 1.26 French Fries (RF)49.90.80321.80.260.13 Cookies81.00.71221.60.160.13 Soft Bread71.02.6344.40.120.08

23 Acrylamide Intake CSFII 1989-92; 2-5 Population Food % eaters Mean Food Consumption Of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) Breakfast Cereal77.91.35133.30.180.14Mean AA Intake of Population (µg/kgbw-d) French Fries (OB)12.21.29663.80.860.10 Cookies41.41.09221.60.240.10 French Fries (RF)20.71.49321.80.480.10 0.78 Potato Chips23.10.73548.00.400.09 Toast34.11.08207.80.220.08 Soft Bread70.71.7444.40.080.05

24 Acrylamide Intake CSFII 1994-96, 1998; 2-5 Population Food % eaters Mean Food Consumption of Eaters (g/kgbw-d) AA Conc (µg/kg) Eaters-only AA intake (µg/kgbw-d) Mean Population AA intake (µg/kgbw-d) French Fries (OB)13.51.88663.81.250.17Mean AA Intake of Population (µg/kgbw-d) Breakfast Cereal73.11.59133.30.210.16 French Fries (RF)22.01.88321.80.610.13 Cookies45.71.28221.60.280.13 1.00 Potato Chips24.60.88548.00.480.12 Toast25.01.08207.80.220.06 Soft Bread60.51.8344.40.080.05

25 Acrylamide Intake Distribution MRCA 1982-87; 2+ Population

26 Acrylamide Intake Distribution CSFII 1989-92; 2+ Population

27 Acrylamide Intake Distribution CSFII 1994-96, 1998; 2+ Population

28 Acrylamide Intake Distribution MRCA 1982-87; 2-5 Population

29 Acrylamide Intake Distribution CSFII 1989-92; 2-5 Population

30 Acrylamide Intake Distribution CSFII 1994-96, 1998; 2-5 Population

31 Acrylamide Intake by Single Serving Food Mean AA Conc (µg/kg) Portion Size (g)*AA (µg)/Portion Breakfast Cereal133.3557.3 Brewed Coffee8.52403.2 Cookies221.6306.6 French Fries (RF)321.87022.5 French Fries (OB)697.87048.8 Potato Chips548.03016.4 Soft Bread44.4502.2 Toast213.0469.8 * Portion Sizes From 21 CFR 101.12, Table 2

32 What-If Scenarios Effect of Mitigation Measure on Population Mean AA Intake Set AA Levels in Chosen Foods to 0 µg/kg Rerun the Model Important to Note that the Foods are Still Included in the Model – they Simply have no Contribution to the Population Mean AA Intake

33 What-If Scenarios CSFII, 1994-96, 98, 2+ Population Population Mean=0.37 µg/kgbw-d Remove AA from French Fries Mean – 0.26 µg/kgbw-d Remove AA from Snack Foods Mean – 0.31 µg/kgbw-d Remove AA from Breakfast Cereal Mean – 0.33 µg/kgbw-d Remove AA from Coffee Mean – 0.34 µg/kgbw-d

34 Future Work Modeling of Longer Term Food Consumption Expand Consumption Duration for Individuals in 2-Day Survey Will More Accurately Model Chronic Intake of Acrylamide Running What-If Scenarios Based on Technological Capability Sensitivity Analysis

35 Summary Mean Population AA Intakes Consistent with Previous Exposure Estimates Greatest Contributors to Mean Population AA Intake are the Same for all Surveys Data Sources affect the Mean Population AA Intake in the Expected Manner

36

37

38 Latin Hypercube Sampling 0 1 Cumulative Probability Distribution Faster Convergence Fewer Iterations Food Consumption Random Number from Each Bin- Equal Chance of any Bin

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