1. 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

2. 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

3. 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

4. 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

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

6. 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

7. 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

8. 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)

9. 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.)

10. Annual Pesticide Report
Summary and detailed analysis of residue data prepared annually by OFS and are available on FDA’s website
Information in reports is widely used by FDA and others including EPA, USDA, Congress, consumers

11. 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

12. 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

13. 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

14. 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)

15. Dioxin Program FDA Dioxin Strategy posted on FDA website
Dioxin levels and exposure estimates from TDS and non-TDS foods posted on FDA website

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

17. 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

18. 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

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

20. 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

21. 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

22. 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)

23. 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 Cesium-137
1200
Plutonium Plutonium Americium-241 2
Ruthenium Ruthenium-106
(C3/6800) + (C6/450) < 1

24. 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

25. 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)

26. 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

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

28. 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

29. 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

30. 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

31. 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)

32. 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)

33. 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

34. 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

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

36. 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

37. 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)

38. 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

39. 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

40. 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

41. 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

42. Questions?