# Presentation: 199050

## The Exposure Assessment for Acrylamide 

- Donna Robie, Ph.D. and Michael DiNovi, Ph.D.
- Office of Food Additive Safety
- February 24, 2003

## 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

## 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

- 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

## Simplified Exposure Equation

- 	  EDIx = The Estimated Daily Intake of Substance x
- 	F = Total no. of foods in which x can be found
- 	Freqf = No. of eating occasions for food f over N survey days
- 	Portf = Average portion size for food f
- 	Concxf = Concentration of the substance x in the food f
- 	N = No. of survey days
- 	Exposures for Individuals Combined

## 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

## 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

## 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

## 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

## Probabilistic Modeling	

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

## Probabilistic Modeling

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

## Monte Carlo Sampling

- 0

- 1

**Food Consumption**

- Cumulative Probability
-          Distribution

- Random Number from Anywhere on
- 	 y-axis

- Generated Value

## 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

## Acrylamide Intake Modeling

| 

Food | 

% Eaters | Mean Food
Consumption
Of Eaters
(g/kgbw-d) | 
AA Conc
(μg/kg) | 
Eater AA Intake
(μg/kgbw-d) |  |
| --- | --- | --- | --- | --- | --- |
| Almonds | 0 | 0.1 | 457.0 | 0.00 | 
AA Intake 
for Eater
(μg/kgbw-d) |
| Bagels | 0 | 0.2 | 11.8 | 0.00 |  |
| Baked Beans | 1 | 1.9 | 70.0 | 0.13 |  |
| Breaded Chicken | 0 | 1.2 | 35.0 | 0.00 | 0.50 |
| Breaded Fish | 0 | 0.6 | 30.0 | 0.00 |  |
| Breakfast Cereal | 0 | 0.4 | 1056.9 | 0.00 |  |
| Brewed Coffee | 1 | 0.8 | 184.5 | 0.14 |  |

**...**

**...**

**...**

**...**

**...**

## 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 – 100th Percentile
- 620g of Cookies per Day – 100th Percentile

## 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

## 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)

## All Tested Foods

| 
Food | Mean Population
AA intake
(ug/kgbw-d) | 
Cumulative Percentile |
| --- | --- | --- |
| French Fries (RF) | 0.056 | 15 |
| French Fries (OB) | 0.049 | 27 |
| Brewed Coffee | 0.047 | 39 |
| Breakfast Cereal | 0.044 | 51 |
| Potato Chips | 0.041 | 61 |
| Cookies | 0.040 | 72 |
| Toast | 0.023 | 78 |
| Soft Bread | 0.020 | 83 |

| 
Food | Mean Population
AA intake
(ug/kgbw-d) | 
Cumulative Percentile |
| --- | --- | --- |
| Corn Snacks | 0.011 | 86 |
| Crackers | 0.008 | 88 |
| Pretzels | 0.008 | 90 |
| Popcorn | 0.006 | 92 |
| Baked Beans | 0.006 | 93 |
| Breaded Chicken | 0.005 | 94 |
| Peanut Butter | 0.004 | 96 |
| Soup Mix | 0.003 | 96 |

## All Tested Foods

| 
Food | Mean Population
AA intake
(ug/kgbw-d) | 
Cumulative Percentile |
| --- | --- | --- |
| Cocoa | 0.002 | 97 |
| Crisp Bread/Matzo | 0.002 | 97 |
| Instant Coffee | 0.002 | 98 |
| Bagels | 0.002 | 98 |
| Chocolate | 0.002 | 99 |
| Tortilla | 0.002 | 99 |
| Breaded Fish | 0.001 | 100 |

| 
Food | Mean Population
AA intake
(ug/kgbw-d) | 
Cumulative Percentile |
| --- | --- | --- |
| Doughnuts | 0.001 | 100 |
| Almonds | 0.000 | 100 |
| Nuts & Seeds | 0.000 | 100 |
| Taro | 0.000 | 100 |
| Soy Protein | 0.000 | 100 |
| Pork Rinds | 0.000 | 100 |
| Malted Drinks | 0.000 | 100 |
| Total | 0.37 |  |

## 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 Cereal | 77.4 | 0.84 | 133.3 | 0.11 | 0.09 | Mean AA Intake of Population 
(μg/kgbw-d) |
| Potato Chips | 75.8 | 0.17 | 548.0 | 0.09 | 0.07 |  |
| Toast | 27.0 | 1.14 | 207.8 | 0.24 | 0.06 |  |
| French Fries (RF) | 48.9 | 0.35 | 321.8 | 0.11 | 0.06 | 0.48 |
| French Fries (OB) | 20.6 | 0.35 | 663.8 | 0.23 | 0.05 |  |
| Cookies | 66.5 | 0.27 | 221.6 | 0.06 | 0.04 |  |
| Soft Bread | 73.0 | 1.14 | 44.4 | 0.05 | 0.04 |  |
| Brewed Coffee | 57.5 | 4.80 | 8.5 | 0.04 | 0.02 |  |

## 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 Cereal | 46.6 | 0.66 | 133.3 | 0.09 | 0.04 | Mean  AA Intake of Population
(μg/kgbw-d) |
| Potato Chips | 18.0 | 0.38 | 548.0 | 0.21 | 0.04 |  |
| French Fries (RF) | 19.4 | 0.60 | 321.8 | 0.19 | 0.04 |  |
| French Fries (OB) | 8.8 | 0.58 | 663.8 | 0.38 | 0.03 | 0.32 |
| Toast | 35.0 | 0.45 | 207.8 | 0.09 | 0.03 |  |
| Cookies | 28.6 | 0.48 | 221.6 | 0.11 | 0.03 |  |
| Brewed Coffee | 47.2 | 7.31 | 8.5 | 0.06 | 0.03 |  |
| Soft Bread | 68.0 | 0.72 | 44.4 | 0.03 | 0.02 |  |

## 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) | 19.0 | 0.91 | 321.8 | 0.29 | 0.06 | Mean AA Intake of Population
(μg/kgbw-d) |
| French Fries (OB) | 8.0 | 0.91 | 663.8 | 0.61 | 0.05 |  |
| Breakfast Cereal | 40.8 | 0.81 | 133.3 | 0.11 | 0.04 |  |
| Potato Chips | 17.2 | 0.44 | 548.0 | 0.24 | 0.04 | 0.37 |
| Cookies | 30.6 | 0.59 | 221.6 | 0.13 | 0.04 |  |
| Brewed Coffee | 45.7 | 7.62 | 8.5 | 0.06 | 0.03 |  |
| Toast | 22.4 | 0.49 | 207.8 | 0.10 | 0.02 |  |
| Soft Bread | 59.4 | 0.78 | 44.4 | 0.03 | 0.02 |  |

## 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 Cereal | 97.2 | 2.27 | 133.3 | 0.30 | 0.29 | Mean AA Intake of Population
(μg/kgbw-d) |
| Potato Chips | 82.9 | 0.40 | 548.0 | 0.22 | 0.18 |  |
| French Fries (OB) | 30.7 | 0.80 | 663.8 | 0.53 | 0.16 |  |
| Toast | 29.0 | 2.63 | 207.8 | 0.55 | 0.16 | 1.26 |
| French Fries (RF) | 49.9 | 0.80 | 321.8 | 0.26 | 0.13 |  |
| Cookies | 81.0 | 0.71 | 221.6 | 0.16 | 0.13 |  |
| Soft Bread | 71.0 | 2.63 | 44.4 | 0.12 | 0.08 |  |

## 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 Cereal | 77.9 | 1.35 | 133.3 | 0.18 | 0.14 | Mean AA Intake of Population
(μg/kgbw-d) |
| French Fries (OB) | 12.2 | 1.29 | 663.8 | 0.86 | 0.10 |  |
| Cookies | 41.4 | 1.09 | 221.6 | 0.24 | 0.10 |  |
| French Fries (RF) | 20.7 | 1.49 | 321.8 | 0.48 | 0.10 | 0.78 |
| Potato Chips | 23.1 | 0.73 | 548.0 | 0.40 | 0.09 |  |
| Toast | 34.1 | 1.08 | 207.8 | 0.22 | 0.08 |  |
| Soft Bread | 70.7 | 1.74 | 44.4 | 0.08 | 0.05 |  |

## 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) | 13.5 | 1.88 | 663.8 | 1.25 | 0.17 | Mean AA Intake of Population
(μg/kgbw-d) |
| Breakfast Cereal | 73.1 | 1.59 | 133.3 | 0.21 | 0.16 |  |
| French Fries (RF) | 22.0 | 1.88 | 321.8 | 0.61 | 0.13 |  |
| Cookies | 45.7 | 1.28 | 221.6 | 0.28 | 0.13 | 1.00 |
| Potato Chips | 24.6 | 0.88 | 548.0 | 0.48 | 0.12 |  |
| Toast | 25.0 | 1.08 | 207.8 | 0.22 | 0.06 |  |
| Soft Bread | 60.5 | 1.83 | 44.4 | 0.08 | 0.05 |  |

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

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

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

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

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

- Acrylamide Intake DistributionCSFII 1989-92; 2-5 Population

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

- Acrylamide Intake DistributionCSFII 1994-96, 1998; 2-5 Population

## Acrylamide Intake by Single Serving

| 
Food | Mean AA Conc
(μg/kg) | Portion
Size (g)* | 
AA (μg)/Portion |
| --- | --- | --- | --- |
| Breakfast Cereal | 133.3 | 55 | 7.3 |
| Brewed Coffee | 8.5 | 240 | 3.2 |
| Cookies | 221.6 | 30 | 6.6 |
| French Fries (RF) | 321.8 | 70 | 22.5 |
| French Fries (OB) | 697.8 | 70 | 48.8 |
| Potato Chips | 548.0 | 30 | 16.4 |
| Soft Bread | 44.4 | 50 | 2.2 |
| Toast | 213.0 | 46 | 9.8 |

- *  Portion Sizes From 21 CFR 101.12, Table 2

## 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

## 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

## 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

## 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

## Slide 36

## Slide 37

## Latin Hypercube Sampling

- 0

- 1

- Cumulative Probability
-          Distribution

- Faster Convergence
- Fewer Iterations

**Food Consumption**

- Random Number from Each Bin-
-      Equal Chance of any Bin