Dr. David Goldman - Meat/Poultry Antibiotic Residue Testing, Protecting Human Health

2,036 views

Published on

Meat/Poultry Antibiotic Residue Testing, Protecting Human Health - Dr. David Goldman, Chief Medical Officer, USPHS Office of Public Health Science, Food Safety and Inspection Service, from the 2013 NIAA Symposium Bridging the Gap Between Animal Health and Human Health, November 12-14, 2013, Kansas City, MO, USA.

More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-antibiotics-bridging-the-gap-animal-health-human-health

1 Comment
2 Likes
Statistics
Notes
No Downloads
Views
Total views
2,036
On SlideShare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
98
Comments
1
Likes
2
Embeds 0
No embeds

No notes for slide
  • The Food Safety and Inspection Service (FSIS) is announcing that it is restructuring the United States National Residue Program (NRP) with respect to how sampling of chemical compounds and animal production and egg product classes is scheduled. To complement this new approach to sampling and scheduling, the Agency is implementing several multi-residue methods for analyzing samples of meat, poultry, and egg products for animal drug residues, pesticides, and environmental contaminants in its inspector-generated testing program. These modern, high-efficiency methods will conserve resources and provide useful and reliable results while enabling FSIS to analyze each sample for more chemical compounds than was previously possible. One of the multi-residue methods being implemented for veterinary drugs will allow the Agency to screen for chemical compounds that include several types of legal and illegal drugs such as antibiotics, anti-inflammatories and growth promoters. In the past, FSIS would have collected 300 samples from 300 cows and looked for just one chemical at a time. Under the new system, one sample may be tested for as many as 55 pesticide chemicals, 9 kinds of antibiotics, various metals, and eventually more than 50 other chemicals. In all, FSIS will assess more compounds per sample using several multi-residue methods.
  • Using multi-analytic methods gives us more information on individual samples – FSIS is conserving resources b/c fewer samples need to be collected (6,000 vs 20,000) for the NRP
  • 2nd column: The number of plants w/in the production class where an inspector performed at least 1 in-plant screen4th column: Total volume of the plants in column 25th column: Ratio of the in-plant screens completed over the total volume for the plants in 2nd column6th column total number of plants that slaughter the production class indicated in column 17th columns – total volume of animals slaughtered within the production class indicated8th column – Ratio of the value in column 2 divided by value in column 69th column – Ration of column 4 divided by column 7 – The meaning of columns 8 & 9 - using beef cows – while only 32% of plants slaughtering beef cows are screened for residues, these plants produce 96% of what is slaughtered -
  • Review of some 2013 Pilot Survey Responses: (Bold Percent % represents response to similar question from 1999 survey results)35% of establishments have a residue control program20% of establishments have a residue-testing plan10% conduct screening tests for residues (13%)8% of establishments experience fewer violative residues due to their residue testing plan6% of establishment’s residue testing plans implement testing at the livestock production unit10% of establishments do not address residues (53%)
  • Objective:A comprehensive hazard identification. Phase Data driven hazard prioritization process.Risk management Hazard ID Multiple Hazard ID Eastern Lab Proposal:EL chemistry to receive 20-30 reserve blinded samples from the microbiology branch per quarter for 4 quarters. The project started in September 2013.The samples will be analyzed by MRM, AMG, and multi-metals methods in support of multiple hazards ID. The samples will be analyzed by the TOX 1 method as part of hazard ID. Future Phases:Unidentified spectra from tox screens will be evaluated/identified.Chemical hazards identified will be risk ranked.Chemical hazards of high priority may result in a targeted testing program.
  • 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/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/chemistry-laboratory-guidebook/chemistry-laboratory-guidebook
  • Multi-Class Residue Method (MRM):Analgesics / Anti-inflammatoryBeta-AgonistsBeta-Lactams / CephalosporinsFluoroquinolonesHormonesMacrolidesPhenicols SulfonamidesTetracyclines
  • Many potential chemical hazards exist that are not animal drugs orpesticide chemicals within the meaning of the FFDCA or FIFRA and thus do not have established tolerances. This group of chemicals without tolerances might include, but is notlimited to, environmental contaminants, heavy metals, industrial chemicals, and mycotoxins. The approach that the Agency is considering consists of the following stages: calculating a de minimis level for the chemical in the relevant food product; determining at what level and prevalence the chemical is present in FSIS-regulated products through monitoring and testing; and, if necessary, taking risk management action in collaboration with federal partners and stakeholders. Questions remain to be answered :Should the first step be to identify the chemical used to calculate a DML?How chemicals will be selected?How will FSIS determine that it needs to establish a DML for a chemical?
  • Dr. David Goldman - Meat/Poultry Antibiotic Residue Testing, Protecting Human Health

    1. 1. Antibiotic Residue Testing in Meat and Poultry - Bridging the Gap to Protect Human Health Dr. David Goldman, MD, MPH Chief Medical Officer, USPHS Assistant Administrator Office of Public Health Science Food Safety & Inspection Service USDA November 13, 2013 Kansas City, MO
    2. 2. United States Department of Agriculture Food Safety and Inspection Service  Overview/Changes to the FSIS National Residue Program  Variability in the Level of In-plant Screening  NARMS Participation & FSIS Multi Hazard Project  FSIS Residue Lab Method (Changes)  Chemicals without Tolerances 2
    3. 3. United States Department of Agriculture Food Safety and Inspection Service 3
    4. 4. United States Department of Agriculture Food Safety and Inspection Service  Purpose • Provide a structured process for identifying and evaluating chemical compounds of concern in food animals • Test for the presence of chemical compounds, including approved (legal) and unapproved (illegal) veterinary drugs, pesticides, hormones, and environmental contaminants in meat, poultry, and egg products. • Identify need for regulatory follow-up when violative levels of chemicals residues are found 4
    5. 5. The domestic sampling includes:  (Headquarters) Scheduled Sampling – which consist of the random sampling of tissue from food animals that have passed ante-mortem inspection.  Inspector Generated Sampling – which is conducted by in-plant personnel (IPP), when the Public Health Veterinarians (PHVs) suspects that an animal may contain violative levels of chemical residues. 5
    6. 6. IPP identifies a carcass to test for residue Positive Send sample to FSIS Laboratory In-Plant Screen Test Owner/Producer Information and all man-made ID recorded Negative Carcass released for human food 6
    7. 7. Surveillance Targeted Testing Program Process Aminoglycosides Method New Testing Scheme Multi Residue Method In-plant screen ---------KIS™ test Positive 7-Plate Bioassay Old Testing Scheme Owner/Producer Information and animal’s ID recorded KIS™ Test Repeat Sulfonamides Flunixin 7
    8. 8. Negative Confirmation Test Positive Qualitative Analysis Completed Carcass released for human food Positive: Quantitation/ Violative Levels Carcass and/or Parts Condemned Positive: Carcass released for human food Quantitated/NonViolative Levels 8
    9. 9. United States Department of Agriculture Food Safety and Inspection Service Improving NRP  FSIS announcement of restructuring NRP - July 2012 News Release : Congressional and Public Affairs – OPPD USDA to Enhance Consumer Safeguards with Expanded Testing for Illegal Drug Residues in Meat. “A new approach to its testing to protect the public from exposure to harmful levels of chemical residues in meat, poultry, and egg products”  New (multi-residue) chemical methods (screens) and samples scheduling algorithms  Impact of implementing new methods - FSIS lab resources conservation b/c analyzing more chemical compound per sample  Revamping the scheduled sampling program by increasing the annual number of samples per slaughter class from 230/300 to 800 per animal class. 9
    10. 10. United States Department of Agriculture Food Safety and Inspection Service Paired MultiAnalyses 108 888 888 888
    11. 11. United States Department of Agriculture Food Safety and Inspection Service Tier 1 – Scheduled Sampling: Appropriate Methods Violative Residues May direct sample for Tier 2 Testing Tier 2 – Targeted Sampling: Appropriate Methods Violative Residues Additional testing Tier 3 – Targeted Flock/Herd: Appropriate Methods Violative Residues Additional testing 11
    12. 12. United States Department of Agriculture Food Safety and Inspection Service FSIS has published the first quarterly report that summarizes chemical residue results for the NRP The report will provide chemical residue testing results more frequently to increase program transparency for all stakeholders  The report is NOT intended to replace the annual report known as FSIS Red Book (FSIS will continue publish)  12
    13. 13. 2012 NRP Preliminary data* (Unpublished – from PHIS) Number of Number of Samples/ chemical animals laboratory tested analysis Domestic Scheduled Samples Inspector Generated Samples 5,627 29,128 Number of Violations 17 (0.302%) 1,136 214,614 27,410 (in 906 animals) (0.53%) Major Violative Compounds Antibiotics -8 Sulfa – 9 Penicillin - 263 Sulfa drugs - 215 Neomycin - 203 Ceftiofur – 170 Flunixin – 96 Tilmicosin - 46 Gentamycin – 38; etc. 13
    14. 14. United States Department of Agriculture Food Safety and Inspection Service 14
    15. 15. United States Department of Agriculture Food Safety and Inspection Service  FSIS residue workgroup looked at level in-plant screening to evaluate the degree of variability in testing across production classes in relation to slaughter volume, animals identified as suspect and/or condemned. 15
    16. 16. Animal Beef Cows Boar/Stags Bob Veal Bulls Dairy Cows Formula-fed Veal Goats Heavy Calves Heifers Lambs Market Swine Mature Sheep Non Formula-fed Veal Roaster Swine Sows Steers Pct InNo of Volume of Tested No of Plants plants Volume of Plants Plants % Total Plants Tested Slaughtering Tested Slaughtering Tests Pct Plants tested % Pct Plants Volume % 161 20,728 3,217,198 0.64 498 3,351,232 32 96 22 260 365,221 0.07 231 420,845 10 87 43 124 42,074 3,769 368,391 543,214 11.42 0.69 60 503 368,697 563,973 72 25 99.92 96 160 95,311 3,112,355 3.06 355 3,116,287 45 99.97 12 1,039 303,071 0.34 26 321,767 46 94 66 578 288,823 0.2 431 557,842 15 52 38 934 24,067 3.88 158 31,385 24 77 175 3,933 9,171,640 0.04 579 9,265,517 30 99 114 1,087 1,620,196 0.07 491 1,867,987 23 87 263 18,066 107,892,856 0.02 566 108,131,881 46 99.78 40 406 88,455 0.46 333 145,217 12 61 26 1,819 7,233 25.15 99 10,604 26 68 64 1,457 599,423 0.24 323 797,304 20 75 65 10,048 2,992,618 0.34 396 3,034,522 16 99 291 13,148 16,049,207 0.08 609 16,152,686 48 99 Source : FSIS DW & PHIS – Feb 2013 16
    17. 17. Selected 2013 Quarter-1 data comparison* - Market Hogs Number Slaughtered Suspect/ Condemned** HQ Generated Samples In-Plant KIS tests Violations HQ/IIC (Antibiotics) A 1,256,536 1910/ 490 7 0 0/0 B 1,485,268 5450/ 1,277 7 389 0/2 1,158/ 828 8 District • C 2,050,176 * Preliminary data from PHIS (Both penicillin) 183 0/0 ** For disease conditions that are subject to residue tests
    18. 18. United States Department of Agriculture Food Safety and Inspection Service    Launched July 1-24 to determine factors affecting residue policy implementation The pilot was sent to FSIS personnel in 67 plants in Des Moines District Mirrors the intent of 1999 survey completed in cull dairy plants 18
    19. 19. United States Department of Agriculture Food Safety and Inspection Service 19
    20. 20. United States Department of Agriculture Food Safety and Inspection Service        Started March 2013 and FDA intends to continue the collaboration ~ 6400 sampling events (chicken, turkey, dairy, beef, market hog, sows) Salmonella, Campylobacter, Enterococcus, and generic E. coli Nationally representative sample weighted by plant volume within slaughter class FSIS collects samples and extracts organisms FDA/CVM performs PFGE, serotyping and antimicrobial resistance profile Comparable to on-farm sampling? 20
    21. 21. Animal Class Sal + % Pos Campy + % Pos Beef Cow Sample Total 353 31 8.8% 74 21.0% Dairy Cow 1121 237 21.2% 473 42.2% 191 90.5% 184 96.8% Heifer 364 31 8.5% 181 49.7% 74 94.9% 61 92.4% Steer 395 37 9.4% 203 51.4% 78 96.3% 62 95.4% Young Chicken 142 33 23.2% 32 22.7% 25 100.0% 22 100.0% Market Swine 455 195 43.1% 136 29.9% 86 97.7% 73 98.6% Sow 385 214 55.9% 113 29.4% 94 98.9% 72 98.6% Young Turkey 101 21 20.8% 7 6.9% 16 100.0% 14 100.0% 3316 799 24.16% 1219 36.77% 636 94.22% 551 96.50% Total E.coli+ % Pos Enterococcus + 72 88.9% 63 % Pos 94.0% 21
    22. 22. United States Department of Agriculture Food Safety and Inspection Service    FSIS has assumed some of the responsibility to continue the animal arm work done since NARMS inception by ARS All further characterization (molecular serotyping, PFGE and antimicrobial susceptibility testing) for HACCP and other salmonella isolates will be performed by FSIS Eastern Lab Results will be stored in the FSIS Data Warehouse and results will be uploaded to PN and NARMS Integrated DB 22
    23. 23. United States Department of Agriculture Food Safety and Inspection Service FSIS is conducting an exploratory pilot program to identify unexpected hazards or multiple concurrent hazards in FSIS regulated products by analyzing reserve microbiology samples with several chemistry residue methods. This sampling program will assist FSIS in defining potential effectiveness of merging microbiology and chemistry sampling programs. 23
    24. 24. United States Department of Agriculture Food Safety and Inspection Service 24
    25. 25. United States Department of Agriculture Food Safety and Inspection Service Product Class → Beef Pork Poultry M, K M, K M, K M**, K** M**, K** M Aminoglycosides M, K, L M, K, L M, K M**, K** M**, K** M Beta-Agonists M, L M, L Phenylbutazone K Screening Methods ↓ MRM* Sheep Goat Equine multiple drug classes Carbadox L L M** M L Flunixin M, L Avermectins M, L, P M, L, P M, L, P M, L, P M, L, P *Consult method for specific applicability M = muscle L = liver K = kidney P **Slated for inclusion during FY14FY14 2014 = Processed Products 25
    26. 26. United States Department of Agriculture Food Safety and Inspection Service 26
    27. 27. United States Department of Agriculture Food Safety and Inspection Service    When tolerances are not available, a separate approach is provided for environmental contaminants to determine monitoring levels for the NRP This is a proposal for a three-step process ◦ Derive a de minimis level ◦ Collect monitoring data ◦ Determine risk management approach This proposal is part of broader improvements to the NRP 27
    28. 28. United States Department of Agriculture Food Safety and Inspection Service Questions? 28
    29. 29. SLTR CLASS # OF INPLANT TESTS # OF POSITIVE IN-PLANT TESTS # OF VIOLATIVE ANIMALs 2,817 BEEF COWS 99,385 19,417 420 (2.83% of tests) (14.9% of positives) 545 DAIRY COWS 64 (2.81% of tests) (11.74% of positives) # OF VIOLATIONS 503 82 VIOLATIVE COMPOUNDS DETECTED Penicillin (147); Ceftiofur (130); Sulfadimethoxine (62); Flunixin (59); Sulfamethazine (33); Gentamycin (19); Ampicillin (13); Tilmicosin (13); Dihydrostreptomycin (7); Neomycin (6); Oxytetracycline (5); Tetracycline (3); etc. Penicillin (21); Tilmicosin (13); Oxytetracycline (12); Flunixin (11) Sulfamethazine (10); Florfenicol (9); Ceftiofur (4); Gentamycin (2). 29
    30. 30. HEIFERS 11,371 3,717 # OF VIOLATIVE ANIMALs 31 (1.99% of tests) (14.6% of positives) 117 STEERS # OF INPLANT TESTS # OF POSITIVE IN-PLANT TESTS 216 SLTR CLASS 16 (3.15% of tests) (17.1% of positives) # OF VIOLATIONS VIOLATIVE COMPOUNDS DETECTED 40 Gentamycin (8); Ceftiofur (7); Tilmicosin (6); Penicillin (5); Sulfadimethoxine (4); Florfenicol (4); Flunixin (3); Sulfamethazine (3); 20 Ceftiofur (4); Sulfamethazine (4) Penicillin (3); Gentamycin (2); Neomycin (1); Tilmicosin (1); Flunixin (1); Sulfadimethoxine (1); Florfenicol (1); etc. 30
    31. 31. SLTR CLASS Bob Veal Calves Non Formula Fed Veal Calves 1,786 # OF VIOLATIVE ANIMALs 283 (1.88% of tests) (35.15% of positives) 107 42,755 # OF POSITIVE IN-PLANT TESTS 802 # OF INPLANT TESTS 23 (5.99% of tests) (21.5% of positives) # OF VIOLATIONS VIOLATIVE COMPOUNDS DETECTED 371 Neomycin (188); Sulfamethoxazole (41); Ceftiofur (26); Sulfamethazine (19); Flunixin (19); Sulfadimethoxine (15); Penicillin (13); Oxytetracycline (12); Tilmicosin (9); Gentamycin (5); etc. 27 Neomycin (14); Sulfadimethoxine (4); Gentamycin (4); Tilmicosin (3); Tulathromycin (2); Sulfamethazine (1); Tulathromycin (2). 31
    32. 32. Sows 10,089 # OF POSITIVE IN-PLANT TESTS # OF VIOLATIVE ANIMALs 189 SLTR CLASS # OF INPLANT TESTS 62 18,074 (35.15% of positives) 160 Market Hogs (1.88% of tests) (5.99% of tests) 78 12 (21.5% of positives) # OF VIOLATIONS 18 VIOLATIVE COMPOUNDS DETECTED Penicillin (75); Sulfadoxine (1); Ceftiofur (1); Naficillin (1). Sulfamethazine (12); Penicillin (4); Lincomycin (1); Ciprofloxacin (1) 32
    33. 33. Selected 2013 Quarter-1 data comparison* - Dairy Cows District Number Slaughtered Suspect/ Condemned** HQ Generated Samples In-Plant KIS tests Violations HQ/IIC (Antibiotics) A 82,559 2118/ 1945 3 2,042 0/7 B 68,650 3571/ 1969 4 1,465 0/9 C 60,094 1872/ 490 9 1,780 0/15 • * Preliminary data from PHIS ** For disease conditions that are subject to residue tests
    34. 34. Selected 2013 Quarter-1 data comparison* - Sows Number Slaughtered Suspect/ Condemned** HQ Generated Samples In-Plant KIS tests Violations HQ/IIC (Antibiotics) A 100,839 1,703/ 540 12 23 0/0 B 104,440 337/66 9 1,204 0/3 District • (All penicillin) C 30,983 * Preliminary data from PHIS 1,221/ 187 15 391 0/6 (All penicillin) ** For disease conditions that are subject to residue tests
    35. 35. Selected 2013 Quarter-1 data comparison* - Bob Veal Calves Number Slaughtered Suspect/ Condemned** HQ Generated Samples In-Plant KIS tests Violations HQ/IIC (Antibiotics) A 23,272 6,059/ 9 15 72 0/33 B 23,337 7,173/ 1,937 20 2,624 0/71 C 22,546 4,064/ 1,280 14 2,719 0/19 District • * Preliminary data from PHIS ** For disease conditions that are subject to residue tests

    ×