Update: National Residue Program

1. Update: National Residue Program P. Bennett, DVM, MS, DACVPM, MPP Office of Public Health Science Food Safety and Inspection Service

2. Outline • Historical Perspectives • NRP Initiatives • Restructure NRP • Establish public health safety levels • Establish methods framework • Questions

3. NRP Mission Statement To protect consumers from unsafe exposure to chemical residues in meat, poultry, and egg products http://www.culinate.com/hunk/29180

4. History of the NRP • 1967-8 Wholesome Meat and Poultry Acts • 1975-1984 Memorandums of Understanding: Give authority to Surveillance Advisory Team (SAT) & Interagency Residue Control Group (IRCG) • 1979Implementation of Swab Test on Premises (STOP) • 1980First Compound Ranking System • 1981 FDA executes first successful prosecution as a result of STOP

5. History of the NRP • 1995 FSIS Implementation of Fast Antimicrobial Screen Test (FAST) • 1996 HACCP Implementation • 2009Begin Kidney Inhibition Swab (KIS) Implementation • 2011Begin using Multi-class method for testing pesticides • 2012Begin using Multi-class method for testing veterinary drugs

6. NRP Goals

7. Collaborative Efforts EPA FDA -Manages farm-to-fork testing and feed analysis -Conducts on-farm investigations -Prevents violations through testing and regulatory action -Enforces the tolerances of animal drugs in meat, poultry, and egg products and prevents improper use of these drugs on farm -Provides data for continuous baseline sampling -Uses residue data to adjust or establish tolerances and safety limits -Regulates the use of pesticides through establishment of tolerances in meat, poultry and egg products and prevents improper use of these chemicals -Improved coordination and communication between tiers - Share residue data, safety limits, and analytical methods

8. Collaborative Efforts

9. Why propose new initiatives? To minimize risks to consumers from chemical hazards To “catch the next melamine” and detect new hazards To more efficiently collect necessary residue data for risk assessments To develop NRP processes that are easily translated for smooth import and export

10. NRP Initiatives

13. Multi-Residue Method (MRM) • Modern approach to residue testing • Collaboration with Agricultural Research Service • FSIS labs received new methods in 2011 • The MRM methods be implemented as part of overall improvements to NRP

14. MRM: a Significant Improvement • Chemical method

15. MRM Classes

16. Analytes in the MRM Classes Fluoroquinolone Desethylene Ciprofloxacin Norfloxacin Ciprofloxacin Danofloxacin Enrofloxacin Sarafloxacin Hormones Prednisone* Macrolide/Lincosamide Lincomycin Pirlimycin Clindamycin Gamithromycin* Tilmicosin Erythromycin Tylosin • Analgesic/Anti-inflammatory • Oxyphenylbutazone (pork only)* • Flunixin • Phenylbutazone (pork only) • Beta/Dexa-methasone* • Tetracycline • Oxytetracline • Tetracyline • Chlortetracycline • Phenicol • Florfenicol Amine (pork only) • Florfenicol • Chloramphenicol * Indicates analytes not tested/not tested in recent years.

17. Analytes in the MRM Classes Sulfonamide Sulfanilamide (pork only)* Sulfadiazine Sulfathiazole Sulfapyridine Sulfamerazine Sulfamethiazole Sulfamethazine Sulfamethoxypyridazine Sulfachloropyridazine Sulfadoxine Sulfamethoxazole Sulfaethoxypyridazine Sulfadimethoxine Sulfaquinoxaline Sulfanitran* • β-Agonist • Salbutamol • Cimaterol • Ractopamine • Β-Lactam/ Cephalosporin • Cefazolin • DCCD • Ampicillin • Difloxacin • Penicillin G • Oxacillin • Cloxacillin • Nafcillin • Dicloxacillin * Indicates analytes not tested/not tested in recent years.

18. Impact of MRM • Screening method • Specific screening • Improved sensitivity • Level assessment • Confirmatory method • Multi class method reduces time and need for class-specific confirmation tests

19. Analytes in the Aminoglycosides Method

20. Pesticide Classes

21. Analytes in the Pesticide Classes Benzimidazole Thiabendazole Carbamate Carbaryl Carbofuran Methomyl Organophosphorus Acephate Azinphos-methyl Chlorpyrifos Chlorpyrifos-methyl Dichlorvos (DDVP) Ethofumesate Tetrachlorvinphos • Organonitrogen Metalaxyl • Tebufenozide • Pyrethroids • Bifenthrin • Cyhalothrin-L • Cypermethrin • Deltamethrin • Permethrin (cis & trans) • Tefluthrin • Triazines • Simazine • Conazoles / Triazoles • Difenoconazole • Myclobutanil • Propiconazole • Tetraconazole

22. Analytes in the Pesticide Classes • Halogenated • Heptachlor epoxide (cis & trans) • Imidacloprid • Linuron • Nonachlor, trans- • Norflurazon • Oxychlordane • Pronamide • Propachlor • Propanil • Pyridaben • Thiamethoxam • Imidazoles • Imazalil • Other Compounds • Indoxacarb • Methoxyfenozide • Mirex • Piperonyl butoxide Halogenated • Alachlor • Aldrin • Boscalid • Carfentrazone-ethyl • Chlordane, cis- • Chlordane, trans- • Clofentezine • Dieldrin • Diflubenzuron • Diuron • Endosulfan I • Endosulfan II • Endosulfan sulfate • Fipronil • Heptachlor

23. Elements in the Metals Method

25. Chemistry Laboratory Guidebook • Methods for the analysis of food composition, food additives, nutrients, veterinary drug and pesticideresidues. • Methods provide analysts with documentation to facilitate training, performance, quality assessment, and interpretation of data. • The contents are continuously revised and updated. • http://www.fsis.usda.gov/Science/Chemistry_Lab_Guidebook/index.asp

26. FSIS Method Implementation:Proposed Timetable

28. National Residue Program • Scheduled Sampling Program • Headquarters generated • Across production classes • Targeted Sampling Program • (Field)Inspector generated • Directed at a particular plant/production class/chemical • Focused

29. 3-Tiered Model Tier 1 – Scheduled Sampling: Violative Residues Appropriate Methods May direct sample for Tier 2 Testing Tier 2 – Targeted Sampling: Appropriate Methods Violative Residues May direct sample for Tier 3 Testing Tier 3 – Targeted Flock/Herd: Appropriate Methods Violative Residues Additional testing

31. Define the Universe of Chemical Hazards Hazard IDand Ranking Screen to Establish a Priority List Risk Based Priority List Select compounds from Priority List Determine appropriate Public Health Safety Level Enter into scheduling algorithm National Residue Program Risk Management

32. NRP Initiatives

33. Public Health Safety Levels -Cadmium

34. NRP Initiatives

35. Performance-based methods • FDA/FSIS collaboration • Develop a process to expedite approval of new testing methodologies for FSIS. • Develop a comparison protocol to facilitate using new analytical methods while retaining the linkage to the safety package prepared to support the new animal drug approval

36. Conclusions http://www.quicklabel.com/blog/wp-content/uploads/2011/07/iStock_000011997708Small.jpg http://media.treehugger.com/assets/images/2011/10/cute-kid-eating-meat-steak-photo.jpg

37. Acknowledgements • Terry Dutko • Patricia Nedialkova • Lynn Cruikshank • Lou Bluhm • Emilio Esteban • Sarah Edwards • Janell Kause • Alice Thaler • Pat Basu • Kerry Dearfield • Vivian Chen • David Goldman • Allie Miraglia • Margaret O’Keefe • Naser Abdelmajid • David LaBarre • Alex Domesle • Jade Mitchell-Blackwood

38. Questions? Patty Bennett Patty.Bennett@FSIS.USDA.gov 202-690-6189