FDA Pesticide Monitoring Program - The IR-4 Projectir4.rutgers.edu/GMUS/23-Charlotte Liang_ACS Fall...
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FDA Pesticide Monitoring Program
Charlotte Liang, Ph.D.Office of Food Safety
Center for Food Safety and Applied NutritionU.S. Food and Drug Administration
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ACS Symposium: Who Should Regulate Pesticides in Our Food?
August 25th, 2016
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U.S. Food and Drug Administration• Many responsibilities
– Food– Drugs (prescription and over‐the‐counter)– Veterinary Products (animal drugs and feed)– Biologics (vaccine, blood, tissue)– Devices (medical, electronic products that give off radiation)
– Tobacco– Cosmetics
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U.S. Food and Drug Administration
• Center for Food Safety and Applied Nutrition (CFSAN) – Food Safety (Pesticides, Radionuclides, Pathogens, Filth, Toxins, Heavy
Metals)
• Center for Veterinary Medicine (CVM)– Feed Safety (focus on feeds for livestock and poultry animals that
ultimately become or produce foods for human consumption).
• Office of Regulatory Affairs (ORA)– Inspections/Investigations– Laboratory Analysis (pesticide testing)
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The FDA Pesticide Residue Program
Six Pesticide Laboratories
SEATTLE
LOS ANGELES
JEFFERSON
NEW YORK
ATLANTA
KANSAS CITY*
*Total Diet Study 4
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• Federal Insecticide Fungicide, and Rodenticide Act (FIFRA):– Registers use of pesticides
• Federal Food, Drug, and Cosmetic Act (FFDCA) – Establishes tolerances– Compliance with tolerances
• Food Quality Protection Act (FQPA)– More stringent safety standards– Protection of children
Pesticide Laws
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EPASets
Tolerances
FDAAll other
foods
Regulatory Agencies
6Interstate Commerce Intrastate Commerce
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FDA Pesticide Monitoring Program
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FDA Pesticide Monitoring Program
Three‐fold Approach:1. Regulatory Monitoring
• Enforce Tolerances
2. Special Assignments• Specific Commodity/Pesticides/Countries
3. Total Diet Study (Market Basket Survey)• Estimate Dietary Exposure to contaminants and nutrients
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Regulatory Monitoring • Domestic – Interstate Commerce
– close to the point of production (at grower, packing sheds, major distribution centers)
• Import – Point of entry
• Sample Types– Raw agricultural commodities (unwashed, whole, unpeeled)– Processed Foods (limited)– Animal Feeds
• Samples per year: 4000‐8000• Analytes: ~800 pesticide per sample
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Regulatory Monitoring• Targeted sampling:
– Violation history – State/USDA monitoring reports– Pesticide usage reports– Dietary significance– Foods consumed by infants & children– Foreign office reports– Volume in commerce– Toxicity & characteristics of pesticides
• Coordination with other agencies 10
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Pesticide Multi‐residue Method (MRM)
QuEChERS Extraction
dSPE Cleanup
LC‐QQQ
dSPE Cleanup
GC‐QQQ GCMS Fullscan
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Violative Shipments• Illegal Residues
– Greater than the EPA tolerances
– Pesticides with no EPA tolerances
• Domestic – Invoke Sanctions– Warning Letter, Seizure, Injunction
• Import – Refuse admission– Import Alert: Detention Without Physical Examination (DWPE)
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DWPE ‐ Imports(Automatic Detention) Sec 801 of the FFDCA
The recommendation may be based on the finding of ONEviolative shipment if there is reason to believe that the same situation will exist in future lots during the same shipping season for a specific shipper, grower, geographic area, or country.
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Import Alerts for Pesticide Residues
• # 99‐05: DWPE of Raw Agricultural Commodities• # 99‐08: DWPE of Processed Foods• # 99‐14: Countrywide DWPE of Raw Ag Commodities
– Dominican Republic: • Squash ( Problems: dimethoate, methamidophos, monocrotophos)• Peas, Snow Peas, Pea Pod, Sugar Snap Peas (Problems: methamidophos, dicrotophos,
monocrotophos, profenofos, chlorpyrifos)
• # 99‐15: Countrywide DWPE of Processed Foods – Hong Kong: Duck Eggs, in shell (Problems: BHC, DDT)– Turkey: Raisins (Problem: procymidone)
FDA Compliance Policy Guide 575.100 “Pesticide Residues in Food and Feed Enforcement Criteria”http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm123236.htm
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Removal from DWPE
• FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or importer from detention without physical examination should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolvedand the agency has confidence that future entries will be in compliance with the Act.
15http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf
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Exports from the United States
• Must comply with U.S. standards while being grown here‐some exceptions
• The responsibility of the grower to comply with destination country standards
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Data from Regulatory Monitoring Program
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Regulatory Monitoring
http://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm2006797.htm
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Regulatory Monitoring
http://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm2006797.htm19
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Regulatory Monitoring
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Year # of ViolativeResidues
Violation Type (%)
No MRL Exceeds MRL
2009 603 96.8 3.2
2010 686 94.5 5.5
2011 996 96.0 4.0
2012 1189 96.8 3.2
2013 1801 97.3 2.7
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Regulatory MonitoringTop violative import products (2013)**
*Commodity was on the FY 2012 table of import commodities warranting special attention.** commodities with > 50 samples analyzed
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Product Vio (%) Product Vio (%)Capsicums, cayenne chili, hot peppers* 56.6 Serrano Pepper 20Rice, Basmati * 49.7 Pepper, hot 14.2Rice, white* 24.2 Olive oil, crude 10.9Papaya* 21.8 Husk Tomato 10.4Pepper, hot, dried/paste 21.2 Mango 10.1Spinach, raw/dried/paste* 21.2
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Special Assignments
• Follow up on suspected area
• In‐depth coverage
• Specific commodity or group
• Raw or processed
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Assignment Year Spls Vio%
EU (milk, eggs, honey) 2013 253 2
Tea (black, green, white) 2013 22 10
Dietary supplements 2013 183 35
Dietary supplements 2011 68 15
Orange juice 2012 184 17
Baby food 2012 27 0
Special Assignments
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Total Diet Study (TDS)
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• Monitor contaminants and nutrients in the food supply
• Estimate exposures:– Acceptable Daily Intakes (ADIs) – Provisional Tolerable Daily/Weekly/Monthly Intakes – Tolerable Upper Intake Levels (ULs)
• Assess contaminant/nutrient trends and risk
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Total Diet Study (TDS)‐Objectives:
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• Analytes:– Pesticide Residues– Industrial Chemicals (PCBs, Perchlorate)– Radionuclides– Toxic & Nutrient Elements – Volatile Organic Compounds
• Serves as an early warning system:– Has much greater sensitivity when compared to FDA’s regulatory
program (10‐100 times more sensitive) – Capable of detecting many more pesticide residues
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Total Diet Study (TDS)
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• 4 regional market baskets each year• 280 foods collected in 3 cities per region• Make “table‐ready”, i.e. cook, peel, fry, etc.• 3 samples per food are composited for analysis
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TDS ‐ Sample Collections
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TDS – Estimate Dietary Intakes• 6 – 11‐month‐old infants• 2‐year‐old children• 6‐year‐old children• 10‐year‐old children• 14 – 16‐year‐old females & males• 25 – 30‐year‐old females & males• 40 – 45‐year‐old females & males• 60 – 65‐year‐old females & males• 70+ ‐year‐old females & males• Total population
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TDS ‐ Findings
Residues Per Market Basket• ~2000 records• 1200 ‐ 1600 residues • 80 % < 10 ppb• 50 % ≤ 1 ppb
29http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/default.htm
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TDS‐Exposures
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Publications• Annual Reports and Residue Monitoring Databaseshttp://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm2006797.htm
• Glossary of Pesticide Chemicalshttp://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/ucm113891.htm
• Pesticide Analytical Manuals (PAM)http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006955.htm
• Total Diet Study‐Analytical Resultshttp://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184293.htm
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Regulatory Monitoring and Special Assignments:Office of Food Safety: [email protected]
Total Diet Study: Office of Analytics and Outreach: [email protected]
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