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FDAs Pesticide Program Young Lee, Ph.D. Office of Plant & Dairy Foods FDA/CFSAN.

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Presentation on theme: "FDAs Pesticide Program Young Lee, Ph.D. Office of Plant & Dairy Foods FDA/CFSAN."— Presentation transcript:

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

3 FDA Organization FDA Commissioner CDERCBERCFSANCDRHCVMORA

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

5 OFFICE OF REGULATORY AFFAIRS Laboratories Nationwide 5 REGIONAL LABS 5 DISTRICT LABS PRL-NW SAN FRANCISCO PRL-SW ` DENVER KANSAS CITY ARL DETROIT FCC PHILADELPHIA NRL WEAC SRL SAN JUAN 2 SPECIALTY LABS 2 MOBILE LABS

6 FDA Residue Monitoring Program Regulatory Monitoring: Enforce Tolerances Regulatory Monitoring: Enforce Tolerances Incidence/Level Monitoring Incidence/Level Monitoring Specific Commodity/Pesticide Total Diet Study (Market Basket Survey) Total Diet Study (Market Basket Survey) Estimate Dietary Exposure

7 FDA Regulatory Monitoring Program Import – Point of entry Import – Point of entry Domestic – Point of production Domestic – Point of production Emphasis EmphasisRAC Foods Consumed by Infants & Children ~ 7,500 Samples Each Year ~ 7,500 Samples Each Year ~ 400 Pesticide Chemicals ~ 400 Pesticide Chemicals

8 FDA Regulatory Monitoring Program - Violative Samples Illegal Residues Illegal Residues > EPA Tolerances No EPA Tolerances Domestic – Invoke Sanctions Domestic – Invoke Sanctions seizure, injunction Import – Refuse admission Import – Refuse admission DWPE DWPE

9 FDA Regulatory Monitoring Program DWPE: Country/ specific geographic area Specific products based on multiple violative samples: Specific products based on multiple violative samples: > 12 detentions, 6 months; and> 12 detentions, 6 months; and Represent > 25% of total shipments; andRepresent > 25% of total shipments; and Represent significant # of firms from the country/ geographic areaRepresent significant # of firms from the country/ geographic area

10 FDA Regulatory Monitoring Program - Factors in planning samples Review of residue data Review of residue data Pesticide use Pesticide use Dietary importance of food Dietary importance of food Foods consumed by infants & children Foods consumed by infants & children Volume in commerce Volume in commerce Toxicity & characteristics of pesticides Toxicity & characteristics of pesticides

11 FDA Regulatory Monitoring Program Sample Collection FDA Regulatory Monitoring Program Sample Collection

12 Domestic & Import Violation Rates*, FY 81 – FY 03 *Data for FY 81 –86 reflect both surveillance and compliance samples

13 Incidence/Level Monitoring Program In-depth coverage In-depth coverage Specific commodity or group Specific commodity or group Raw or processed Raw or processed

14 Incidence/Level Monitoring Program Aquaculture Survey, FY 90 - 94 Aquaculture Survey, FY 90 - 94 Milk Survey, FY 90 - 93 Milk Survey, FY 90 - 93 US Manufactured Pesticides (Circle of Poisons), FY 94 US 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 95 Triazine Herbicides, FY 95 Wheat Imported from Canada, FY 99 Wheat Imported from Canada, FY 99 Forchlorfenuron on Mexican Grapes, FY 99 Forchlorfenuron on Mexican Grapes, FY 99 Canola – Dom & Imp from Canada, FY 00 Canola – Dom & Imp from Canada, FY 00 Dietary supplement ginseng, FY 02 – 03 Dietary supplement ginseng, FY 02 – 03 Dietary supplements, FY 04, 06, 07 Dietary supplements, FY 04, 06, 07

15 Statistically Based Surveys Objective: 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: 4 commodities: Tomatoes, pears, apples, riceTomatoes, pears, apples, rice Widely consumed year roundWidely consumed year round Have a significant domestic & import componentHave a significant domestic & import component Cost: ~ $ 1 mil / commodity Cost: ~ $ 1 mil / commodity

17 Statistically Based Surveys FY 03-05 Conclusion: Conclusion: Corroborate the low levels of pesticide residues found in FDAs regulatory monitoring.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.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 Determine levels Estimate dietary intakes – 14 age/sex groups Estimate dietary intakes – 14 age/sex groups Identify trends and changes in the levels Identify trends and changes in the levels

19 Total Diet Study Revised 2003 USDAs National Food Consumption Surveys USDAs National Food Consumption Surveys >3,500 Foods Identified 282 Foods Selected 282 Foods Selected Analysis of individual foods as eaten Analysis of individual foods as eaten Modified analytical methods Modified analytical methods (1 – 2 ppb range for many)

20 TDS – Population Groups 6 – 11-month-old infants 6 – 11-month-old infants 2-year-old children 2-year-old children 6-year-old children 6-year-old children 10-year-old children 10-year-old children 14 – 16-year-old females & males 14 – 16-year-old females & males 25 – 30-year-old females & males 25 – 30-year-old females & males 40 – 45-year-old females & males 40 – 45-year-old females & males 60 – 65-year-old females & males 60 – 65-year-old females & males 70+ -year-old females & males 70+ -year-old females & males

21 TDS – 4 regional market baskets WEST NORTH CENTRAL NORTH EAST SOUTH

22 Total Diet Study Food Purchases 4 Times per year 4 Times per year Local grocery stores Local grocery stores Each market basket – 3 cities in a given region Each market basket – 3 cities in a given region Standard metropolitan statistical area Standard metropolitan statistical area

23 TDS - Analytes Pesticide residues Pesticide residues Radionuclides Radionuclides Industrial chemicals Industrial chemicals Toxic elements Toxic elements Trace & macro elements Trace & macro elements Folate Folate

24 Total Diet Study Summary of Findings ~ 300 Pesticide chemicals ~ 300 Pesticide chemicals ~ 70 chemicals found ~ 70 chemicals found Estimated Intakes Estimated Intakes < FAO/WHOs ADIs < EPAs RDs Rarely exceed 1% of ADIs Rarely exceed 1% of ADIs

25 TDS Summary of Findings Occurrence of Pesticide Residues Carbaryl, Chlorpropham, Chlorpyrifos Chlorpyrifos-methyl, DDT, Dieldrin Endosulfan, Malathion, Permethrin

26 FQPA of 1996 Revocation of Tolerances Channels of Trade Provision Channels of Trade Provision Vinclozolin Methyl Parathion

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

28 International Cooperative Agreements MOU – New Zealand MOU – New ZealandStrawberry Action Plan on Food Safety – Canada Action Plan on Food Safety – CanadaMicrobials Pesticide Residues Collaboration Program – Spain Collaboration Program – SpainClementines

29 CFSAN – Pesticide Program http://www.cfsan.fda.gov/~lrd/pestadd.html Annual reports Annual reports Residue monitoring databases Residue monitoring databases Glossary of pesticide chemicals Glossary of pesticide chemicals Pesticide analytical behavior data Pesticide analytical behavior data Pesticide analytical manuals (PAM I & II) Pesticide analytical manuals (PAM I & II) Total Diet Study residue data Total Diet Study residue data


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