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

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

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

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

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

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 =

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

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

Dietary Exposure Modeling DEEM-FCID/Calendex SHEDS-Multimedia

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

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.)

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 different food commodities

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.)

Food Commodity Intake Database: Example

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.

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 http://fcid.foodrisk.org/

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/

DEEM – User Interface

DEEM – User Interface

DEEM – User Interface

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

What’s Next FCID Recipe Database JIFSAN foodrisk.org Website Finalized 2003-08 FCID Recipe Database Anticipate completing 2009-10 recipe updates in October-2012 JIFSAN foodrisk.org Website 2003-06 FCID Recipe Database available for download Working to make 2003-08 FCID Recipe Database available Finalizing consumption calculator DEEM-WWEIA 2003-08 Available through EPA/OPP website Performing model-to-model comparisons Upcoming ISES Dietary Symposium (Oct-2012)

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

Questions

Extra Slides

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

Search Recipes by Food Name

Generate Recipe Report

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