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Update: National Residue Program

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Presentation on theme: "Update: National Residue Program"— Presentation transcript:

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 Questions
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

4 History of the NRP 1967-8 Wholesome Meat and Poultry Acts
Memorandums of Understanding: Give authority to Surveillance Advisory Team (SAT) & Interagency Residue Control Group (IRCG) 1979 Implementation of Swab Test on Premises (STOP) 1980 First 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 2009 Begin Kidney Inhibition Swab (KIS) Implementation 2011 Begin using Multi-class method for testing pesticides 2012 Begin using Multi-class method for testing veterinary drugs

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

7 Collaborative Efforts
FDA EPA -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
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 IRCG: Interagency Residue Control Group: FSIS/FDA/EPA/AMS/ CDC/ARS; monthly meetings for updates and collaborating relative to the NRP SAT: Surveillance Advisory Team: Interagency committee that determines the chemical compounds and production classes of public health concern

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 Restructure NRP Establish public health safety levels
Establish methods framework

11 Restructure NRP Tiered approach Hazard ID and ranking New methods

12 Restructure NRP Tiered approach Hazard ID and ranking New methods

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
Distinguish analytes individual types of analytes Screen many First time FSIS method to analyze multiple chemicals per sample Screen up to 120+ NOT JUST ANTIBIOTICS First time FSIS to use this type of method Chemical method

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

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

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

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

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

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
Metals Elements Lead Cadmium Manganese Thallium Selenium Cobalt Molybdenum Highlighted elements are currently being validated

24 MU: Method of Uncertainty

25 Chemistry Laboratory Guidebook
Methods for the analysis of food composition, food additives, nutrients, veterinary drug and pesticide residues. Methods provide analysts with documentation to facilitate training, performance, quality assessment, and interpretation of data. The contents are continuously revised and updated. debook/index.asp

26 FSIS Method Implementation: Proposed Timetable
2012 MRM method: Targeted sampling Aminoglycosides Method: Scheduled and Targeted sampling programs Metals method: Exploratory program 2013 MRM as a screening method in Eastern and Western labs for Scheduled sampling program In 2011, FSIS implemented the pesticide method

27 Restructure NRP Tiered approach Hazard ID and ranking New methods

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

30 Restructure NRP Tiered approach Hazard ID and ranking New methods

31 Hazard ID and Ranking 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

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

33 Public Health Safety Levels -Cadmium
Developing policies Peer Review FDA Input Methodology to determine PH safety levels

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

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

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

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

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