Ensuring Food Safety and Health Standards

Explore the historical perspectives and initiatives taken by the NRP to establish public health safety levels, monitor chemical exposure, and respond to stakeholder concerns regarding chemical hazards in meat products. Learn about the key goals of the NRP in revising residue sampling algorithms, improving documentation of hazards, and developing recall protocols.

• Food safety
• Public health
• NRP initiatives
• Chemical exposure
• Meat products

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1. P. Bennett, DVM, MS, DACVPM, MPP Office of Public Health Science Food Safety and Inspection Service 1

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

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

4. c00d0896 1967 1975 Surveillance Advisory Team (SAT) & Interagency Residue Control Group (IRCG) 1979 Implementation of Swab Test on Premises (STOP) 1967- -8 1975- -1984 8 Wholesome Meat and Poultry Acts 1984 Memorandums of Understanding: Give authority to 1979 Feeding hogs. 1980 1981 1980 First Compound Ranking System 1981 FDA executes first successful prosecution as a result of STOP 4

5. c00d0896 1995 (FAST) 1996 2009 2011 testing pesticides 2012 testing veterinary drugs 1995 FSIS Implementation of Fast Antimicrobial Screen Test 1996 HACCP Implementation 2009 Begin Kidney Inhibition Swab (KIS) Implementation 2011 Begin using Multi-class method for Feeding hogs. 2012 Begin using Multi-class method for 5

6. NRP Goals NRP Goals Revise residue sampling & scheduling algorithms Revise residue sampling & scheduling algorithms Monitor chemical exposure in the industry Monitor chemical exposure in the industry Improve Improve documentation of chemical hazards documentation of chemical hazards Respond to public and stakeholder concern Respond to public and stakeholder concern Identify trends and high- -priority compounds to research Identify trends and high compounds to research priority Develop analytical techniques and improve analysis Develop analytical techniques and improve analysis Establish protocol for recall decisions Establish protocol for recall decisions 6

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

8. MOU: Memorandum of Understanding: Working relationship between FSIS, AMS, FDA, EPA to coordinate regulatory activities for residues FSIS consults mainly with FDA/EPA to compare information on regulations MOU: Memorandum of Understanding: IRCG: Interagency Residue Control Group: FSIS/FDA/EPA/AMS/ CDC/ARS; monthly meetings for updates and collaborating relative to the NRP IRCG: Interagency Residue Control Group: SAT: Surveillance Advisory Team: Interagency committee that determines the chemical compounds and production classes of public health concern SAT: Surveillance Advisory Team: 8

9. 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 9

10. Restructure NRP Restructure NRP Establish public health safety levels Establish methods framework 10

11. New methods Restructure NRP Tiered approach Hazard ID and ranking 11

12. New methods Restructure NRP Tiered approach Hazard ID and ranking 12

13. 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 13

14. MRM: MRM: a Significant a Significant I Improvement mprovement Distinguish individual analytes Chemical method NOT JUST ANTIBIOTICS First time FSIS to use this type of method NOT JUST ANTIBIOTICS Screen many types of analytes First time FSIS method to analyze multiple chemicals per sample Screen up to 120+ analytes 14

15. Beta Beta- -Agonists Agonists Beta Cephalosporins Beta- -Lactams & Cephalosporins Lactams & Hormones Hormones Macrolides & Lincosamides Macrolides & Lincosamides MRM Classes MRM Classes Analgesics & Anti inflammatory Analgesics & Anti- - inflammatory Phenicols Phenicols Fluoroquinolones Fluoroquinolones Sulfas Sulfas Tetracyclines Tetracyclines 15

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

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

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

19. Analytes in the Aminoglycosides Method Neomycin Neomycin Gentamicin Gentamicin Spectinomycin Spectinomycin Apramycin Apramycin Aminoglycosides Analytes Aminoglycosides Analytes Dihydrostreptomycin Dihydrostreptomycin Hygromycin B Hygromycin B Amikacin Amikacin Streptomycin Streptomycin Kanamycin Kanamycin 19

20. Benzimidazole Benzimidazole Carbamate Carbamate Conazoles/Triazoles Conazoles/Triazoles Halogenated Halogenated Pesticide Classes Pesticide Classes Imidazoles Imidazoles Organonitrogen Organonitrogen Organophosphates Organophosphates Pyrethroids Pyrethroids Triazines Triazines 20

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

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

23. Elements in the Metals Method Elements in the Metals Method Lead Lead Cadmium Cadmium Manganese Manganese Metals Elements Metals Elements Thallium Thallium Selenium Selenium Cobalt Cobalt Molybdenum Molybdenum 23

24. MU (normalized) for quantitative FSIS CLG methods 180 140 Relative % 100 60 20 Sulfamethoxazole (SUL) Ivermectin Ractopamine Mirex Doramectin Doramectin Tilmicosin *** Penicillin Carbadox Alpha-BHC p,p'-DDE Cadmium Cadmium Moxidectin Moxidectin Sulfadiazine (SUL) Sulfamethazine (SUL2) Flunixin Flunixin *** Ampicillin *** Tetracycline Sulfathiazole (SUL) Aldrin Lead Lead Arsenic *** Oxytetracycline Sulfadimethoxine (SUL2) Chloramphenicol Florfenicol Florfenicol *** Neomycin Sulfathiazole (SUL2) Ivermectin *** Tylosin *** Chlortetracycline Sulfamethazine (SUL) Desfuroylceftiofur (as DCA or DCCD) Sulfadimethoxine (SUL) *** denotes 7-plate bioassay 24

25. Methods for the analysis of food composition, food additives, nutrients, veterinary drug residues veterinary drug and pesticide pesticide residues. 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_Gui debook/index.asp 25

26. FSIS Method Implementation: Proposed Timetable MRM method: Targeted Aminoglycosides Method: Scheduled sampling programs Metals method: Exploratory Targeted sampling Scheduled and Targeted Targeted 2012 Exploratory program MRM as a screening method in Eastern and Western labs for Scheduled Scheduled sampling program 2013 26

27. New methods Restructure NRP Tiered approach Hazard ID and ranking 27

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

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

30. New methods Restructure NRP Tiered approach Hazard ID and ranking 30

31. Define the Universe of Chemical Hazards 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 31

32. Restructure NRP Establish public health safety levels Establish public health safety levels Establish methods framework 32

33. Developing policies Peer Review FDA Input Methodology to determine PH safety levels Methodology to determine PH safety levels 33

34. Restructure NRP Establish public health safety levels Establish methods framework Establish methods framework 34

35. 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 35

36. The NRP initiatives will result in: Prevent Discourage improper behavior by producers, processors, and importers adulterated meat, poultry, and egg products from entering the marketplace Close regulatory gaps between Agencies Identify emerging contaminants 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 36

37. 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 37

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