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

1

Discussion Outline

• FDA Compliance Programs– 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

2

Compliance Programs

• Purpose:– Determine occurrence of contaminants in

specific targeted foods– Surveillance & regulatory follow-up

• Special assignments when needed– Surveillance or regulatory follow-up

3

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

4

Pesticides and Industrial Chemicals in Domestic and

Imported Foods

• Pesticide Program• Dioxin Program

5

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

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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

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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) 8

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.)9

Annual Pesticide Report• Summary and detailed analysis of residue data

prepared annually by OFS and are available on FDA’s websitehttp://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/UCM2006797.htm

• Information in reports is widely used by FDA and others including EPA, USDA, Congress, consumers

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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

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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

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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 exposure13

Dioxin Program/AnalytesProgram 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)14

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

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

• Toxic Elements in Food• Radionuclides in Food

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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

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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

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Toxic Elements/Analytes

• Lead• Cadmium• Mercury (seafood)• Total arsenic and inorganic arsenic (non-

seafood)

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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

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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

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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)

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Radionuclide Guidance Level

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

Derived Intervention Levels (DILs) for Each Radionuclide Group for Food in Domestic Commerce and Food Offered for Import

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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

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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)– Honey

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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

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Chemotherapeutics Program/Analytes for Honey

• Fluoroquinolones• Nitrofurans

metabolite• Phenicols• Sulfonamides

• Amino glycoside• Lincosamide• Fumagillin• Macrolides• Tetracyclines

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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

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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

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Mycotoxins/FDA action levels and guidance levels

Mycotoxin 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

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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)

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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)

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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

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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

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TDS Sample Collections

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

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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

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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)

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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

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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

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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

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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

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Questions?

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