1. Dietary Exposure Assessment Activities at U. S
Dietary Exposure Assessment Activities at U.S. EPA's Office Pesticide Programs
Interagency Risk Assessment Consortium/CAFPA
FDA – Center for Food Safety and Applied Nutrition
Aaron Niman LT, USPHS
Office of Pesticide Programs US Environmental Protection Agency
September 27, 2012
Health Effects Division
Office of Pesticide Programs

2. Overview U.S. EPA’s Office of Pesticide Programs (OPP)
OPP’s dietary exposure assessment methodology
Dietary Exposure Assessment Resources
Food Commodity Intake Database (FCID)
JIFSAN Foodrisk.org Web Application
Dietary Exposure Evaluation Model (DEEM)
Stochastic Human Exposure and Dose Simulation (SHEDS) Model

3. EPA’s Office of Pesticide Programs
Antimicrobials
Health Effects
Environmental Fate & Effects
Biopesticides & Pollution Prevention
Biological & Economic Analysis
Registration
Pesticide Re-Evaluation
Field & External Affairs IT
Office Director
Registers pesticides for agricultural, residential, and public health applications
Evaluates safety of pesticides by assessing exposure and associated risks
Establishes legal limits (aka “tolerances”) for pesticides on agricultural commodities

4. Regulatory Framework Major OPP Regulatory Statutes Federal Statute
Key Features
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)
Established U.S. EPA as pesticide licensing agency
Established risk/benefit standard for registering pesticide products
Grants U.S. EPA strong authority to obtain toxicity and exposure data from pesticide registrants
Grants U.S. EPA ability to regulate labels and packaging
Federal Food, Drug, and Cosmetic Act
(FFDCA)
Grants U.S. EPA authority to establish pesticide tolerances for foods and feeds
Requires that FDA and USDA monitor and enforce tolerances

5. Regulatory Framework Food Quality Protection Act of 1996
Amended both FIFRA and FFDCA
Major impact on OPP Program Office
Established more health protective standard
Require OPP to re-evaluate over 10,000 pesticide tolerances
Required more advanced assessment methods
Aggregate pesticide exposure
Diet + Residential + Water
Cumulative effects of pesticides with common mode of toxicity
Evaluate exposure to multiple OP pesticide, rather than individual compounds
Special sensitivity of infants and children

6. Dietary Exposure Assessment
Approach
Evaluate food consumption patterns and residue concentrations that lead to highest potential for exposure
Assessments range from simple to complex, but based on same general exposure algorithm
Tiering process used to refine exposure assessment to reflect more realistic assumptions
Consumption
Residue
Dietary
Exposure X =

7. Dietary Exposure Modeling
Exposure assessment models based on nationally-representative monitoring surveys
Key data surveys and databases:
USDA’s Pesticide Data Program (PDP)
Nationally representative commodity residue sampling program
Continuing Survey of Food Intake by Individuals (CSFII) ( /1998)
NHANES’ What We Eat In America (WWEIA)
Nationally representative food consumption surveys
U.S. EPA’s Food Commodity Intake Database (FCID)
Recipe database that links WWEIA foods to PDP residue data

8. Dietary Exposure Modeling
Food Consumption
(WWEIA)
Food Recipe Database
(FCID)
Raw Ingredient Consumption
Dietary Exposure =
Ingredient Pesticide Residue
(USDA/PDP)
Acceptable Level
aPAD, cPAD, etc.
Risk

9. Dietary Exposure Modeling
DEEM-FCID/Calendex
SHEDS-Multimedia

10. Dietary Resources Food Commodity Intake Database
Recipe database used by EPA/OPP in exposure assessment models
Developed using CSFII, , 1998
Updated for NHANES-WWEIA,
Foodrisk.org Web Application
FCID recipe search tool
Links to NHANES-WWEIA
Population-based consumption estimates
Dietary Exposure Evaluation Model (DEEM)
Dietary exposure assessment mode
Now free and publically available
Utilizes NHANES WWEIA survey data
Stochastic Human Exposure and Dose Simulation (SHEDS) Model
Developed by EPA’s Office of Research and Development

11. Food Commodity Intake Database (FCID)
Both CSFII and WWEIA capture dietary recall data on foods as reported eaten
Examples:
1 slice apple pie,
1 Big Mac™ ,
1 slice Cheese Pizza (1/8 of 12” pie)
Pesticide residue information and regulatory focus is on a food commodity basis
Therefore, estimating dietary exposure requires converting data on foods “as eaten” to food commodities (e.g, tomato sauce, wheat flour, apples, soybean oil, beef, milk, etc.)

12. Food Commodity Intake Database (FCID)
Translates foods as reported eaten to raw agricultural commodities using U.S. EPA food vocabulary
Developed in collaboration with USDA ‘s Agricultural Research Service
Originally based on:
CSFII /1998
USDA’s Food and Nutrient Database for Dietary Studies (FNDDS)
Converts more than 5,000 food codes into recipes containing roughly 540 different food commodities

13. Food Commodity Intake Database (FCID)
Also includes additional information on food commodities (used subsequently in exposure modeling)
Cooked Status (Yes, No)
Food Form (Fresh, frozen, etc.)
Cooking Method (Baked, boiled, etc.)

14. Food Commodity Intake Database: Example

15. Updating FCID: WWEIA 2003-2008 New Recipe Formation
New recipes were needed for foods that were not included in earlier versions of FCID.
Some of these new foods were easily matched to an already existing recipe for a similar food that was in the CSFII-FCID database, with little or no modification necessary.
Other foods required generating a recipe “from scratch,” or using an already existing recipe but applying significant alterations to their ingredients.

16. FCID Accessibility http://fcid.foodrisk.org/
Developed database and user interface in MS Access
Web application with USDA’s Food Safety Inspection Service and U-Maryland’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
Functionality
Improve transparency of coded fields
Make recipes fully searchable
Make recipe format more user-friendly
Enable users to estimate consumption of food commodities
Weighted mean and percentile calculations

17. Dietary Exposure Evaluation Model (DEEM)
EPA/OPP has acquired DEEM license and made freely available to the public
Improve accessibility
Increase transparency of EPA/OPP regulatory decisions
DEEM Updates and Release
Incorporates WWEIA consumption data
Addressed stakeholder feedback from Fall 2011 beta testing
Enables eating occasion analysis

18. DEEM – User Interface

19. DEEM – User Interface

20. DEEM – User Interface

21. SHEDS-Multimedia
State-of-the-science model developed by EPA’s Office of Research and Development
Enables longitudinal assessment of exposure from multimedia sources
SHEDS-Residential v.4: Residential model that can simulate cumulative or aggregate residential exposures over time via multiple routes of exposure for different types of chemicals and scenarios.
SHEDS-Dietary v.1: Dietary model that can simulate individual exposures to chemicals in food and drinking water over different time periods
Collaborated closely with EPA’s Office of Pesticide Programs with extensive peer-review by the FIFRA Scientific Advisory Panel

22. What’s Next FCID Recipe Database JIFSAN foodrisk.org Website
Finalized FCID Recipe Database
Anticipate completing recipe updates in October-2012
JIFSAN foodrisk.org Website
FCID Recipe Database available for download
Working to make FCID Recipe Database available
Finalizing consumption calculator
DEEM-WWEIA
Available through EPA/OPP website
Performing model-to-model comparisons
Upcoming ISES Dietary Symposium (Oct-2012)

23. Exposure Assessment Resources
FCID Recipe Database
DEEM-WWEIA
SHEDS-Multimedia

24. Questions

25. Extra Slides

26. New Recipe Formation Step 1 Step 1.A Step 2 Step 3 Step 4
Identify food nutrients
Step 1.A
Conduct internet search to determine food description and ingredients (if necessary)
Step 2
Search existing recipes for similar food
Step 3
Use similar existing recipe as starting point for new recipe
Step 4
Modify/add/delete recipe commodities to match new recipe nutrient information

27. Search Recipes by Food Name

28. Generate Recipe Report

29. Dietary Exposure Modeling
Modeling tools rely on probabilistic techniques (Monte-Carlo) to evaluate exposure
Techniques are routinely applied by OPP for virtually all of its pesticide risk assessments
Allow the Agency to characterize and quantify the variability in dietary exposure across various subgroups of interest X =
All Residue Values
All Consumption Values
Range of Dietary
Exposures