FDA Compliance Programs and Total Diet Study FDA Food Advisory Committee Meeting September 29, 2014 Paul South, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration

Discussion Outline FDA Compliance Programs FDA Total Diet Study Pesticides and Industrial Chemicals in Domestic and Imported Foods Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic Chemotherapeutics in Seafood Mycotoxins in Domestic and Imported Foods FDA Total Diet Study

Compliance Programs Purpose: Special assignments when needed Determine occurrence of contaminants in specific targeted foods Surveillance & regulatory follow-up Special assignments when needed Surveillance or regulatory follow-up

Information Sources Considered when Planning Samples FDA monitoring (e.g., Compliance Programs, Total Diet Study, Field Assignments, FDA Inspections) CAERS (CFSAN Adverse Event Reporting System), Reportable Food Registry (RFR), Recall data Other federal agencies, state and local governments, other countries (e.g., Codex, RASFF) Scientific publications, scientific meetings, academia Industry, consumers, Congress

Pesticides and Industrial Chemicals in Domestic and Imported Foods Pesticide Program Dioxin Program

Pesticide Program EPA is responsible under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for Registration of pesticides Setting tolerances if use of a particular pesticide may result in residues in or on food FDA is charged with enforcing tolerances in domestic and imported foods (except meat, poultry, and certain egg products) shipped in interstate commerce

Pesticide Program/Factors in Planning Samples Analysis of residue data (FDA and others) including violative samples Foods consumed by infants & children Toxicity & characteristics of pesticides Pesticide usage data Dietary significance Volume in commerce

Pesticide Program/Proposed FY15 Samples Domestic/Import Samples with focus on: Raw agricultural foods of dietary importance (i.e., foods that comprise the greater part of the U.S. diet that can contribute most to pesticide exposure) Foods consumed in large amounts by infants and children Food with high violation rates (i.e., foods with residue levels above tolerance or with no tolerance)

Pesticide Program/Analytes Approximately 600 pesticide residues (parent and metabolites) including: Carbamates with emphasis on aldicarb and carbofuran Synthetic pyrethroids Benomyl and thiophanate-methyl (where post-harvest application of the fungicides is indicated) EBDCs Neonicitinoid pesticides (acetamiprid, clothianidin, dinotefuran, etc.) Chlorophenoxy acids (2,3,4,6-tetrachlorophenol, 2,3,6-TBA, 2,4,5-T, etc.) Substituted urea pesticides (chlorobromuron, chloroxuron, diuron, etc.)

Annual Pesticide Report Summary and detailed analysis of residue data prepared annually by OFS and are available on FDA’s website http://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/UCM2006797.htm Information in reports is widely used by FDA and others including EPA, USDA, Congress, consumers

Dioxin Program Dioxin and chemically-related compounds (referred to as dioxin-like compounds or DLCs) found in food-producing animals Studies suggest DLC exposure may lead to a variety of adverse health effects including reproductive and developmental problems, cardiovascular disease, increased diabetes, and increased cancer

FDA Dioxin Strategy Obtain profiles of background levels of DLCs in a wide variety of food and feed Identify opportunities for DLC reduction by eliminating or reducing contamination sources Provide estimates of dietary DLC exposure

Dioxin Program/Proposed FY15 Samples Animal-based foods/Domestic and Import Milk and dairy products, eggs, seafood (fish and shellfish) including aquaculture and wild Associated feed samples for aquaculture fish Total Diet Study samples 232 TDS foods TDS samples and associated consumption data used to estimate dietary exposure

Dioxin Program/Analytes Program includes DLCs as well as other halogenated compounds: Polychlorinated dibenzo-p-dioxin (7 congeners) Polychlorinated dibenzofuran (10 congeners) Dioxin-like Polychlorinated Biphenyls (PCBs) (12 congeners) Non-dioxin-like PCBs (13 congeners) Polybrominated Diphenyl Ethers (PBDEs) (6 congeners)

Dioxin Program FDA Dioxin Strategy posted on FDA website Dioxin levels and exposure estimates from TDS and non-TDS foods posted on FDA website http://www.fda.gov/Food/FoodborneIllnessContaminants/ChemicalContaminants/ucm2006784.htm

Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic

Toxic Elements Program Toxic elements may occur in food due to agricultural practices, industrial emissions or natural occurrence Exposure to toxic elements may result in adverse health effects including kidney damage, endocrine disruption, developmental and immunological disorders, cancer and death Program designed to monitor foods that contribute most to toxic element exposure, particularly for sensitive populations

Toxic Elements/Proposed FY15 Samples Domestic Fruit, vegetables, milk, eggs, seafood (including aquaculture and wild), game meat, honey, juice and juice concentrate, candy Import Fruit, vegetables, cereal products, seafood (including aquaculture and wild), juice and juice concentrate, candy, spices

Toxic Elements/Analytes Lead Cadmium Mercury (seafood) Total arsenic and inorganic arsenic (non-seafood)

Radionuclides in Food Greatest potential for accidental contamination results from peacetime uses of radioactive materials, such as for generating nuclear power, both domestically and abroad (e.g., Fukushima, Chernobyl) Samples analyzed to determine current levels and trends and to assess dietary exposure

Radionuclides/Proposed FY15 Samples Domestic Milk (retail) Seafood Samples in vicinity of nuclear reactors (fish, milk, raw vegetables, food crops of local importance) Import (Japan) Fruits, vegetables, rice, tea, dairy, seafood and associated products

Radionuclides/Analytes Gamma-ray emitters, e.g., Cesium-134, Cesium-137, Iodine-131, Potassium-40, Ruthenium-103, Ruthenium-106 Beta emitter = Strontium-90 Tritium (if targeting nuclear power plant emissions)

Radionuclide Guidance Level Derived Intervention Levels (DILs) for Each Radionuclide Group for Food in Domestic Commerce and Food Offered for Import Radionuclide Group DIL (Bq/kg) Strontium-90 160 Iodine-131 170 Cesium-134 + Cesium-137 1200 Plutonium-238 + Plutonium-239 + Americium-241 2 Ruthenium-103 + Ruthenium-106 (C3/6800) + (C6/450) < 1

Chemotherapeutics in Seafood Certain chemotherapeutics are approved animal drugs used for aquaculture seafood Increased production and consumption of aquaculture seafood Acute response can occur from hypersensitivity or allergenicity from certain drug residues found in food Antibiotic drug residues may also result in antibiotic resistant bacteria

Chemotherapeutics Program/Proposed FY15 Samples Domestic Aquaculture seafood (crab, crayfish, lobster, shrimp, tilapia, salmon, trout) Honey Import Aquaculture seafood (crab, crayfish, eel, frog legs, lobster, salmon, shrimp, tilapia, trout)

Chemotherapeutics Program/Analytes for Seafood Chloramphenicol Nitrofurans (Furazolidone, Furaltadone, Nitrofurazone, Nitrofurantoin) Triphenylmethane Dyes: Malachite Green, Gentian (Crystal) Violet, and Brilliant Green Quinolones: (Flumequine, Oxolinic Acid and Nalidixic Acid) Fluoroquinolones (Cipro, Enro, Sara, and Difloxacin) Sulfonamides Trimethoprim Mectins (Ivermectin, Emamectin) Methyltestosterone Tetracyclines

Chemotherapeutics Program/Analytes for Honey Fluoroquinolones Nitrofurans metabolite Phenicols Sulfonamides Amino glycoside Lincosamide Fumagillin Macrolides Tetracyclines

Mycotoxin Program Mycotoxins are toxic metabolites produced by certain fungi that grow on various agricultural commodities Environmental factors (e.g., temperature, humidity, and rainfall) can affect mycotoxin levels Occurrence of mycotoxins is not entirely avoidable

Mycotoxin Program/Proposed FY15 Samples Domestic Cereal grains (corn, wheat, barley, rye, oat, rice) and products (breakfast cereals, baby cereals, snack foods, bakery goods), tree nuts, peanuts, apple juice and concentrate Import Same as domestic but also spices

Mycotoxins/FDA action levels and guidance levels Susceptible Food FDA Action Level/Guidance Level Aflatoxin Corn, peanuts, tree nuts, dairy products 20 ppb all products (M1 0.5 ppb in milk) Fumonisin Corn 2-4 ppm corn products Deoxynivalenol Wheat 1 ppm finished wheat products Patulin Apple juice 50 ppb apple juice and apple products Ochratoxin A Wheat, barley, beans, raisins, coffee

EU Audit Assignment European Union (EU) conducted an audit in 2010 of FDA and USDA programs designed to monitor chemical contaminants in domestically produced animal derived foods The audit identified differences between the EU and FDA in the design and respective programs to monitor these analytes Multi year assignments were issued in 2012 to analyze certain pesticide residues, chemotherapeutic agents, industrial contaminants, and toxic elements in milk, eggs, honey and game meat (bison, deer, elk, rabbit)

FY15 Field Assignments/Chemical Contaminants Chemical residues and contaminants in domestic and imported honey (EU audit) Chemical residues and contaminants in conventionally and organically produced/ free range domestic eggs (EU audit) Chemical residues and contaminants in game meat including bison, deer, elk, rabbit (EU audit)

Total Diet Study The Total Diet Study (TDS), sometimes called the market basket study, is an ongoing FDA program that determines levels of various contaminants and nutrients in foods The food list represents typical American diet, updated periodically to reflect changes Foods are prepared and analyzed as consumed to provide realistic estimates of dietary exposure

Total Diet Study Purpose: Determine background levels of contaminants in a wide range of food To focus resources for FDA compliance programs TDS exposure estimates indicate potential risks/identify main dietary sources That information used by compliance programs to design sampling plans

TDS Sample Collections 4 regional market baskets collected each year 280 foods collected in 3 cities per region 3 samples composited for analysis

TDS Food List Includes major components of the average American diet Based on national food consumption survey results Limited to foods available nationwide Revised periodically to reflect changing dietary patterns

TDS Food Types Dairy/eggs (milk, cheese) Meat/poultry/fish Grain/starches/baked goods (bread, rice) Fruits/vegetables (fresh & processed, juices) Mixtures (casseroles, sandwiches, soups, pizza) Snack foods (potato chips, popcorn) Candy/sweets/sugars/syrups Beverages (coffee, tea, bottled water) Fats/oils (butter, salad dressings, cream)

TDS: Analytes Each TDS food is analyzed routinely for Pesticide residues (> 600) Industrial chemicals (e.g., PCBs) Radionuclides (13) Elements (6 toxic, 5 nutrient) TDS foods analyzed periodically for other substances (e.g., perchlorate, acrylamide, dioxin) TDS generates > 20,000 data points each year

TDS Role TDS designed as broad, time-trend survey -- not to enforce regulations Results used for: monitor the impact of regulatory actions identify potential health hazards provide support for risk assessments and international food standards

International Importance of TDS TDS results submitted to WHO’s GEMS/Food database used for international standard setting by Codex recent CCCF working group on lead headed by the U.S. to reassess Codex maximum levels for lead U.S. submitted ~12,000 data points including TDS data also important for international risk assessments conducted by JECFA (Joint FAO/WHO Expert Committee on Food Additives), JMPR (Joint FAO/WHO Meeting on Pesticide Residues) WHO actively promoting TDS programs worldwide FDA co-sponsored first international workshop FDA TDS experts involved in subsequent workshops + training

Revitalizing CFSAN TDS Rebuilding staff/capacity More efficient and timely data management Evaluation of the sampling protocol New food list Revitalization of web presence/content

Questions?