FDA

1
FDAs Pesticide Program

• Young Lee, Ph.D.
• Office of Plant Dairy Foods
• FDA/CFSAN

2
Regulation of Pesticides

• EPA FIFRA - Registers Use of Pesticides
• FFDCA - Establishes tolerances
• FDA Compliance with Tolerance
• USDA/FSIS Compliance with Tolerance
• Meat Poultry

3
FDA Organization
4
OFFICE OF REGULATORY AFFAIRS 190 OFFICES IN FY
2004
NORTHEAST
AL
PACIFIC
CENTRAL
NH
ME
VT
ND
MN
WA
MA
NY
WI
SD
MT
RI
MI
CT
OR
NJ
PA
ID
OH
MD
IN
IL
DE
WV
VA
KY
NV
CA
WY
IA
NE
TN
NC
AZ
SC
UT
GA
AL
CO
KS
MS
MO
HI
PR
LA
OK
AR
NM
VI
REGIONAL OFFICES - 5 DISTRICT OFFICES -
20 RESIDENT INSPECTION POSTS - 140 OCI FIELD
OFFICES - 6 OCI RESIDENT OFFICES - 6 OCI
DOMICILES - 13
FL
TX
SOUTHEAST
SOUTHWEST
3/03
Division of Planning, Evaluation, Mgmt ORA
Offices.ppt
5
OFFICE OF REGULATORY AFFAIRS Laboratories
Nationwide
PRL-NW
WEAC
DETROIT
NRL
SAN FRANCISCO
KANSAS CITY
PHILADELPHIA
DENVER
FCC
PRL-SW
ARL
SRL
5 DISTRICT LABS
5 REGIONAL LABS

2 SPECIALTY LABS
2 MOBILE LABS
SAN JUAN
6
FDA Residue Monitoring Program

• Regulatory Monitoring Enforce Tolerances
• Incidence/Level Monitoring
• Specific Commodity/Pesticide
• Total Diet Study (Market Basket Survey)
• Estimate Dietary Exposure

7
FDA Regulatory Monitoring Program

• Import Point of entry
• Domestic Point of production
• Emphasis
• RAC
• Foods Consumed by Infants Children
• 7,500 Samples Each Year
• 400 Pesticide Chemicals

8
FDA Regulatory Monitoring Program- Violative
Samples

• Illegal Residues
• gt EPA Tolerances
• No EPA Tolerances
• Domestic Invoke Sanctions
• seizure, injunction
• Import Refuse admission
• DWPE

9
FDA Regulatory Monitoring ProgramDWPE Country/
specific geographic area

• Specific products based on multiple violative
  samples
• gt 12 detentions, 6 months and
• Represent gt 25 of total shipments and
• Represent significant of firms from the
  country/ geographic area

10
FDA Regulatory Monitoring Program- Factors in
planning samples

• Review of residue data
• Pesticide use
• Dietary importance of food
• Foods consumed by infants children
• Volume in commerce
• Toxicity characteristics of pesticides

11
FDA Regulatory Monitoring Program Sample
Collection
12
Domestic ImportViolation Rates, FY 81 FY 03
Data for FY 81 86 reflect both surveillance and
compliance samples
13
Incidence/Level Monitoring Program

• In-depth coverage
• Specific commodity or group
• Raw or processed

14
Incidence/Level Monitoring Program

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

15
Statistically Based Surveys

• Objective
• To determine how violation rates, frequency of
  occurrence of residues, residue levels obtained
  differ from those obtained through FDAs
  traditional surveillance approach.

16
Statistically Based Surveys

• 4 commodities
• Tomatoes, pears, apples, rice
• Widely consumed year round
• Have a significant domestic import component
• Cost 1 mil / commodity

17
Statistically Based Surveys FY 03-05

• Conclusion
• Corroborate the low levels of pesticide residues
  found in FDAs regulatory monitoring.
• Demonstrate that FDAs regulatory monitoring
  provides a reasonably reliable estimate of
  pesticide residues in the U.S. food supply.

18
Total Diet Study Objectives

• Determine levels
• Estimate dietary intakes 14 age/sex groups
• Identify trends and changes in the levels

19
Total Diet Study Revised 2003

• USDAs National Food Consumption Surveys
• gt3,500 Foods Identified
• 282 Foods Selected
• Analysis of individual foods as eaten
• Modified analytical methods
• (1 2 ppb range for many)

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TDS Population Groups

• 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

21
TDS 4 regional market baskets
22
Total Diet StudyFood Purchases

• 4 Times per year
• Local grocery stores
• Each market basket 3 cities in a given region
• Standard metropolitan statistical area

23
TDS - Analytes

• Pesticide residues
• Radionuclides
• Industrial chemicals
• Toxic elements
• Trace macro elements
• Folate

24
Total Diet StudySummary of Findings

• 300 Pesticide chemicals
• 70 chemicals found
• Estimated Intakes
• lt FAO/WHOs ADIs
• lt EPAs RDs
• Rarely exceed 1 of ADIs

25
TDS Summary of FindingsOccurrence of Pesticide
Residues

• Carbaryl, Chlorpropham, Chlorpyrifos
• Chlorpyrifos-methyl, DDT, Dieldrin
• Endosulfan, Malathion, Permethrin

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FQPA of 1996Revocation of Tolerances

• Channels of Trade Provision
• Vinclozolin
• Methyl Parathion

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Channels of Trade ProvisionFFDCA

• How long residues of a pesticide are expected to
  remain in various foods.
• How long fresh/processed foods may remain in
  channels of trade.
• Whether the presence of the residue is a result
  of lawful application of a pesticide.

28
International Cooperative Agreements

• MOU New Zealand
• Strawberry
• Action Plan on Food Safety Canada
• Microbials
• Pesticide Residues
• Collaboration Program Spain
• Clementines

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CFSAN Pesticide Programhttp//www.cfsan.fda.go
v/lrd/pestadd.html

• Annual reports
• Residue monitoring databases
• Glossary of pesticide chemicals
• Pesticide analytical behavior data
• Pesticide analytical manuals (PAM I II)
• Total Diet Study residue data