Dietary Exposure Assessment Activities at U.S. EPA's Office Pesticide Programs

1. Dietary Exposure Assessment Activities at U.S. EPA's Office Pesticide Programs Interagency Risk Assessment Consortium Workshop on Chemical Food Safety Risk Assessment FDA – Center for Food Safety and Applied Nutrition Aaron NimanLT, USPHS Office of Pesticide ProgramsUS Environmental Protection Agency June 14, 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. Office Director EPA’s Office of Pesticide Programs Antimicrobials Health Effects Environmental Fate & Effects • 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 Biopesticides & Pollution Prevention Biological & Economic Analysis Registration Pesticide Re-Evaluation Field & External Affairs IT

4. 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 Residue Consumption Dietary Exposure = X

5. 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) (1994-96/1998) 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

6. 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

7. 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 Consumption Values All Residue Values Range of Dietary Exposures

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

9. Dietary Resources • Food Commodity Intake Database • Recipe database used by EPA/OPP in exposure assessment models • Developed using CSFII, 1994-96, 1998 • Updated for NHANES-WWEIA, 2003-08 • 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 2003-08 survey data • Stochastic Human Exposure and Dose Simulation (SHEDS) Model • Developed by EPA’s Office of Research and Development • Simulates aggregate and cumulative dietary exposure

10. Food Commodity Intake Database (FCID) • Both CSFII and WWEIA Captures 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.)

11. 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 1994-96/1998 • USDA’s Food and Nutrient Database for Dietary Studies (FNDDS) • Converts more than 5,000 food codes into recipes containing roughly 540 difference food commodities

12. 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.)

13. Food Commodity Intake Database: Example

14. 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.

15. FCID Accessibility • Developed database and user interface in MS Access • Web application with USDA’s Food Safety Inspection Service and U-Maryland’s Joint Institute of 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 http://fcid.foodrisk.org/

16. 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 2003-08 consumption data • Addressed stakeholder feedback from Fall 2011 beta testing • Enables eating occasion analysis http://www.epa.gov/pesticides/science/deem/

17. DEEM – User Interface

18. DEEM – User Interface

19. DEEM – User Interface

20. 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 http://www.epa.gov/heasd/products/sheds_multimedia/sheds_mm.html

21. SHEDS-Dietary v.1: Longitudinal Analysis

22. SHEDS-Dietary v.1: Uncertainty Analysis

23. What’s Next • FCID Recipe Database • FCID 2003-06 available through foodrisk.org • Working to finalize 2003-08 recipe CR-ROM and make available through JIFSAN foodrisk.org website • DEEM-WWEIA 2003-08 • Available through EPA/OPP website • Performing model-to-model comparisons • Upcoming ISES Dietary Symposium (Oct-2012) • SHED-Dietary • Available through EPA/ORD website

24. Exposure Assessment Resources FCID Recipe Database http://fcid.foodrisk.org/ DEEM-WWEIA 2003-08 http://www.epa.gov/pesticides/science/deem/ SHEDS-Multimedia http://www.epa.gov/heasd/products/sheds_multimedia/sheds_mm.html

25. Questions

26. Extra Slides

27. New Recipe Formation Step 1 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

28. Search Recipes by Food Name

29. Generate Recipe Report