FDA’s Pesticide ProgramFDA’s Pesticide Program

Young Lee, Ph.D. Young Lee, Ph.D.

Office of Plant & Dairy Foods Office of Plant & Dairy Foods

FDA/CFSANFDA/CFSAN

Regulation of PesticidesRegulation of Pesticides

EPA: EPA: FIFRA - Registers Use of PesticidesFIFRA - Registers Use of Pesticides

FFDCA - Establishes tolerancesFFDCA - Establishes tolerances

FDA:FDA: Compliance with ToleranceCompliance with Tolerance

USDA/FSIS: USDA/FSIS: Compliance with ToleranceCompliance with Tolerance

Meat & PoultryMeat & Poultry

FDA OrganizationFDA Organization

FDA Commissioner

CDER CBER CFSANCFSAN CDRH CVMCVM ORAORA

OFFICE OF REGULATORY AFFAIRS190 OFFICES IN FY 2004

NORTHEASTPACIFIC CENTRAL

SOUTHEAST

SOUTHWEST3/03

Division of Planning, Evaluation, & MgmtORA Offices.ppt

REGIONAL OFFICES - 5DISTRICT OFFICES - 20RESIDENT INSPECTION POSTS - 140OCI FIELD OFFICES - 6OCI RESIDENT OFFICES - 6OCI DOMICILES - 13

CA

NV

WA

MT

ORID

AL

HI

AZ

UT

WY

CO

NM

TX

OK AR

MO

IANE

KS

TN NC

GAALMS

LA

FL

SC

PR

MEVT

NY

NH

MA

CTRI

MN

WI

IL

MI

INOH

PA

WV

KYVA

NJ

ND

SD

MDDE

VI

OFFICE OF REGULATORY AFFAIRSLaboratories Nationwide

5 REGIONAL LABS

5 DISTRICT LABS

PRL-NW

SAN FRANCISCO

PRL-SW

`

DENVERKANSAS CITY

ARL

DETROIT

FCCPHILADELPHIA

NRL

WEAC

SRL

SAN JUAN

2 SPECIALTY LABS

2 MOBILE LABS

FDA Residue Monitoring ProgramFDA Residue Monitoring Program

Regulatory Monitoring: Regulatory Monitoring: Enforce TolerancesEnforce Tolerances

Incidence/Level MonitoringIncidence/Level MonitoringSpecific Commodity/PesticideSpecific Commodity/Pesticide

Total Diet Study (Market Basket Survey)Total Diet Study (Market Basket Survey)

Estimate Dietary ExposureEstimate Dietary Exposure

FDA Regulatory Monitoring FDA Regulatory Monitoring ProgramProgram

Import – Import – Point of entryPoint of entry

Domestic – Domestic – Point of productionPoint of production

Emphasis Emphasis RAC RAC Foods Consumed by Infants & Foods Consumed by Infants &

ChildrenChildren

~ 7,500 Samples Each Year~ 7,500 Samples Each Year ~ 400 Pesticide Chemicals~ 400 Pesticide Chemicals

FDA Regulatory Monitoring ProgramFDA Regulatory Monitoring Program

- Violative Samples - Violative Samples

Illegal ResiduesIllegal Residues

> EPA Tolerances> EPA TolerancesNo EPA TolerancesNo EPA Tolerances

DomesticDomestic – Invoke Sanctions – Invoke Sanctions

seizure, injunctionseizure, injunction

Import Import – – Refuse admissionRefuse admission DWPEDWPE

FDA Regulatory Monitoring ProgramFDA Regulatory Monitoring ProgramDWPE: Country/ specific geographic areaDWPE: Country/ specific geographic area

Specific products based on multiple Specific products based on multiple violative samples:violative samples:

• >> 12 detentions, 6 months; and 12 detentions, 6 months; and

• Represent Represent >> 25% of total shipments; and 25% of total shipments; and

• Represent significant # of firms from the Represent significant # of firms from the country/ geographic areacountry/ geographic area

FDA Regulatory Monitoring ProgramFDA Regulatory Monitoring Program

- Factors in planning samples- Factors in planning samples

Review of residue dataReview of residue data Pesticide usePesticide use Dietary importance of foodDietary importance of food Foods consumed by infants & childrenFoods consumed by infants & children Volume in commerceVolume in commerce Toxicity & characteristics of pesticidesToxicity & characteristics of pesticides

FDA Regulatory Monitoring ProgramFDA Regulatory Monitoring Program Sample CollectionSample Collection

0

20004000

60008000

1000012000

1400016000

18000

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

*

20

05

*

20

06

*

Fiscal Year

No

. o

f S

amp

les

Domestic & ImportDomestic & ImportViolation Rates*, FY 81 – FY 03Violation Rates*, FY 81 – FY 03

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00

Fiscal Year

% V

iola

tio

n R

ate

Imported samples

Domestic Samples

*Data for FY 81 –86 reflect both surveillance and compliance samples

Incidence/Level Monitoring ProgramIncidence/Level Monitoring Program

In-depth coverageIn-depth coverage

Specific commodity or groupSpecific commodity or group

Raw or processedRaw or processed

Incidence/Level Monitoring ProgramIncidence/Level Monitoring Program

Aquaculture Survey, FY 90 - 94Aquaculture Survey, FY 90 - 94 Milk Survey, FY 90 - 93Milk Survey, FY 90 - 93 US Manufactured Pesticides (Circle of Poisons), FY 94US Manufactured Pesticides (Circle of Poisons), FY 94 Foods Eaten by Infants & Children, FY 94 -Foods Eaten by Infants & Children, FY 94 - Statistically Based Surveys, FY 93 - 95 Statistically Based Surveys, FY 93 - 95 Triazine Herbicides, FY 95Triazine Herbicides, FY 95 Wheat Imported from Canada, FY 99Wheat Imported from Canada, FY 99 Forchlorfenuron on Mexican Grapes, FY 99Forchlorfenuron on Mexican Grapes, FY 99 Canola – Dom & Imp from Canada, FY 00Canola – Dom & Imp from Canada, FY 00 Dietary supplement ginseng, FY 02 – 03Dietary supplement ginseng, FY 02 – 03 Dietary supplements, FY 04, 06, 07 Dietary supplements, FY 04, 06, 07

Statistically Based SurveysStatistically Based Surveys

Objective:Objective:

To determine how violation rates, frequency To determine how violation rates, frequency of occurrence of residues, residue levels of occurrence of residues, residue levels obtained differ from those obtained through obtained differ from those obtained through FDA’s traditional surveillance approach.FDA’s traditional surveillance approach.

Statistically Based SurveysStatistically Based Surveys

4 commodities:4 commodities:

• Tomatoes, pears, apples, riceTomatoes, pears, apples, rice

• Widely consumed year roundWidely consumed year round

• Have a significant domestic & Have a significant domestic & import componentimport component

Cost: ~ $ 1 mil / commodityCost: ~ $ 1 mil / commodity

Statistically Based Surveys Statistically Based Surveys FY 03-05FY 03-05

Conclusion:Conclusion:• Corroborate the low levels of pesticide Corroborate the low levels of pesticide

residues found in FDA’s regulatory residues found in FDA’s regulatory monitoring.monitoring.

• Demonstrate that FDA’s regulatory Demonstrate that FDA’s regulatory monitoring provides a reasonably reliable monitoring provides a reasonably reliable estimate of pesticide residues in the U.S. estimate of pesticide residues in the U.S. food supply.food supply.

Total Diet Study ObjectivesTotal Diet Study Objectives

Determine levelsDetermine levels

Estimate dietary intakes – 14 Estimate dietary intakes – 14 age/sex groupsage/sex groups

Identify trends and changes in Identify trends and changes in the levelsthe levels

Total Diet Study Total Diet Study Revised 2003Revised 2003

USDA’s National Food Consumption USDA’s National Food Consumption SurveysSurveys

>3,500 Foods Identified>3,500 Foods Identified

282 Foods Selected282 Foods Selected

Analysis of individual foods as eatenAnalysis of individual foods as eaten

Modified analytical methodsModified analytical methods(1 – 2 ppb range for many)(1 – 2 ppb range for many)

TDS – Population GroupsTDS – Population Groups 6 – 11-month-old infants6 – 11-month-old infants 2-year-old children2-year-old children 6-year-old children6-year-old children 10-year-old children10-year-old children 14 – 16-year-old females & males14 – 16-year-old females & males 25 – 30-year-old females & males25 – 30-year-old females & males 40 – 45-year-old females & males40 – 45-year-old females & males 60 – 65-year-old females & males60 – 65-year-old females & males 70+ -year-old females & males70+ -year-old females & males

TDS – TDS – 4 regional market baskets4 regional market baskets

WESTNORTHCENTRAL

NORTHEAST

SOUTH

Total Diet StudyTotal Diet StudyFood PurchasesFood Purchases

4 Times per year4 Times per year Local grocery storesLocal grocery stores Each market basket – Each market basket – 3 cities in a given 3 cities in a given

regionregion

Standard metropolitan statistical areaStandard metropolitan statistical area

TDS - AnalytesTDS - Analytes

Pesticide residuesPesticide residues RadionuclidesRadionuclides Industrial chemicalsIndustrial chemicals Toxic elementsToxic elements Trace & macro elementsTrace & macro elements FolateFolate

Total Diet StudyTotal Diet StudySummary of FindingsSummary of Findings

~ 300 Pesticide chemicals~ 300 Pesticide chemicals ~ 70 chemicals found ~ 70 chemicals found Estimated IntakesEstimated Intakes

< FAO/WHO’s ADIs< FAO/WHO’s ADIs

< EPA’s RDs< EPA’s RDs Rarely exceed 1% of ADIsRarely exceed 1% of ADIs

TDS Summary of FindingsTDS Summary of FindingsOccurrence of Pesticide ResiduesOccurrence of Pesticide Residues

Carbaryl, Chlorpropham, ChlorpyrifosCarbaryl, Chlorpropham, ChlorpyrifosChlorpyrifos-methyl, DDT, DieldrinChlorpyrifos-methyl, DDT, DieldrinEndosulfan, Malathion, Permethrin Endosulfan, Malathion, Permethrin

FQPA of 1996FQPA of 1996Revocation of TolerancesRevocation of Tolerances

• Channels of Trade ProvisionChannels of Trade Provision

VinclozolinVinclozolinMethyl ParathionMethyl Parathion

Channels of Trade ProvisionChannels of Trade ProvisionFFDCAFFDCA

How long residues of a pesticide are How long residues of a pesticide are expected to remain in various foods.expected to remain in various foods.

How long fresh/processed foods may How long fresh/processed foods may remain in channels of trade.remain in channels of trade.

Whether the presence of the residue is a Whether the presence of the residue is a result of lawful application of a pesticide.result of lawful application of a pesticide.

International Cooperative AgreementsInternational Cooperative Agreements

MOU – New ZealandMOU – New Zealand

StrawberryStrawberry

Action Plan on Food Safety – CanadaAction Plan on Food Safety – Canada

MicrobialsMicrobials

Pesticide ResiduesPesticide Residues Collaboration Program – SpainCollaboration Program – Spain

ClementinesClementines

CFSAN – Pesticide ProgramCFSAN – Pesticide Programhttp://www.cfsan.fda.gov/~lrd/pestadd.htmlhttp://www.cfsan.fda.gov/~lrd/pestadd.html

Annual reportsAnnual reports Residue monitoring databasesResidue monitoring databases Glossary of pesticide chemicalsGlossary of pesticide chemicals Pesticide analytical behavior dataPesticide analytical behavior data Pesticide analytical manuals (PAM I & II)Pesticide analytical manuals (PAM I & II) Total Diet Study residue dataTotal Diet Study residue data