FDA’s Pesticide Program

1. FDA’s 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 DE IL 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 > 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: • > 12 detentions, 6 months; and • Represent > 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 ProgramSample 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 FDA’s 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 FDA’s regulatory monitoring. • Demonstrate that FDA’s 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 • USDA’s National Food Consumption Surveys >3,500 Foods Identified • 282 Foods Selected • Analysis of individual foods as eaten • Modified analytical methods (1 – 2 ppb range for many)

20. 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. NORTH EAST NORTH CENTRAL WEST SOUTH 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 < FAO/WHO’s ADIs < EPA’s RDs • Rarely exceed 1% of ADIs

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

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

27. 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

29. CFSAN – Pesticide Programhttp://www.cfsan.fda.gov/~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