Dr. David Goldman - Meat/Poultry Antibiotic Residue Testing, Protecting Human Health
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Transcript of Dr. David Goldman - Meat/Poultry Antibiotic Residue Testing, Protecting Human Health
Dr. David Goldman, MD, MPHChief Medical Officer, USPHS
Assistant AdministratorOffice of Public Health Science
Food Safety & Inspection Service USDA
November 13, 2013Kansas City, MO
Antibiotic Residue Testing in Meat and Poultry
- Bridging the Gap to Protect Human Health -
2
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
Presentation Outline
United States Department of AgricultureFood Safety and Inspection Service
3
NRP Overview/Changes
United States Department of AgricultureFood Safety and Inspection Service
4
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
National Residue Program
United States Department of AgricultureFood Safety and Inspection Service
National Residue Program
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
Inspector-generated: Sampling Flow Diagram
IPP identifies a carcass to
test for residue
In-Plant Screen Test
PositiveSend sample to
FSIS Laboratory
Negative
Carcass released for human food
Owner/Producer Information and all
man-made ID recorded
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7
In-plant screen
----------
KIS™ test Positive
New Testing Scheme
Aminoglycosides Method
Multi Residue Method
Old Testing Scheme
KIS™ Test Repeat
7-Plate Bioassay
Sulfonamides
Flunixin
Owner/Producer Information and
animal’s ID recorded
Surveillance Targeted Testing Program Process
Sample Flow Diagram - FSIS Laboratory
Confirmation Test Positive
Qualitative Analysis
Completed
NegativeCarcass released for human food
Positive: Quantitation/
Violative LevelsCarcass and/or
Parts Condemned
Positive: Quantitated/Non-Violative Levels
Carcass released for human food
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9
FSIS announcement of restructuring NRP - July 2012News Release : Congressional and Public Affairs – OPPDUSDA 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.
Improving NRP
United States Department of AgricultureFood Safety and Inspection Service
Paired Multi-Analyses
800 samples
Many production
classes
Multiple compounds
1 production class – 300 samples
Single compound
10888888888
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Advantages
United States Department of AgricultureFood Safety and Inspection Service
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3-Tiered Model
Additional testing
Tier 1 – Scheduled Sampling:
Appropriate Methods Violative Residues
Tier 2 – Targeted Sampling:
Violative Residues
Tier 3 – Targeted Flock/Herd:
May direct sample
for Tier 2 Testing
Appropriate Methods
Violative Residues
Appropriate Methods Additional testing
United States Department of AgricultureFood Safety and Inspection Service
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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)
Quarterly Residue Report
United States Department of AgricultureFood Safety and Inspection Service
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2012 NRP Preliminary data*(Unpublished – from PHIS)
Number of Samples/animalstested
Number of chemical
laboratory analysis
Number of Violations
Major Violative Compounds
Domestic Scheduled Samples
5,627 29,128 17
(0.302%)Antibiotics -8Sulfa – 9
InspectorGenerated Samples
214,614 27,4101,136
(in 906 animals)
(0.53%)
Penicillin - 263Sulfa drugs - 215Neomycin - 203 Ceftiofur – 170Flunixin – 96Tilmicosin - 46Gentamycin – 38; etc.
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Evaluating Variability in the level of in-plant
screening for chemical residues
United States Department of AgricultureFood Safety and Inspection Service
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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.
Variability in in-plant screening for chemical residues
United States Department of AgricultureFood Safety and Inspection Service
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AnimalNo of
PlantsTested
In-plantsTotal Tests
Volume of Plants Tested
Pct Tested
%No of PlantsSlaughtering
Volume of Plants
Slaughtering
Pct Plants tested
%
Pct PlantsVolume
%
Beef Cows 161 20,728 3,217,198 0.64 498 3,351,232 32 96
Boar/Stags 22 260 365,221 0.07 231 420,845 10 87
Bob Veal 43 42,074 368,391 11.42 60 368,697 72 99.92
Bulls 124 3,769 543,214 0.69 503 563,973 25 96
Dairy Cows 160 95,311 3,112,355 3.06 355 3,116,287 45 99.97
Formula-fed Veal 12 1,039 303,071 0.34 26 321,767 46 94
Goats 66 578 288,823 0.2 431 557,842 15 52
Heavy Calves 38 934 24,067 3.88 158 31,385 24 77
Heifers 175 3,933 9,171,640 0.04 579 9,265,517 30 99
Lambs 114 1,087 1,620,196 0.07 491 1,867,987 23 87
Market Swine 263 18,066 107,892,856 0.02 566 108,131,881 46 99.78
Mature Sheep 40 406 88,455 0.46 333 145,217 12 61
Non Formula-fed Veal 26 1,819 7,233 25.15 99 10,604 26 68
Roaster Swine 64 1,457 599,423 0.24 323 797,304 20 75
Sows 65 10,048 2,992,618 0.34 396 3,034,522 16 99
Steers 291 13,148 16,049,207 0.08 609 16,152,686 48 99
CY2012 In-plant Testing / Slaughter Volume By Animal Class
Source : FSIS DW & PHIS – Feb 2013
•
Selected 2013 Quarter-1 data comparison*- Market Hogs -
DistrictNumber
SlaughteredSuspect/
Condemned**HQ
GeneratedSamples
In-Plant KIS tests
ViolationsHQ/IIC
(Antibiotics)
A 1,256,536 1910/490
7 0 0/0
B 1,485,268 5450/1,277
7 389 0/2(Both
penicillin)
C 2,050,176 1,158/828
8 183 0/0
* Preliminary data from PHIS ** For disease conditions that are subject to residue tests
18
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
In-Plant Testing (Pilot) Survey
United States Department of AgricultureFood Safety and Inspection Service
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NARMS PARTICIPATION
United States Department of AgricultureFood Safety and Inspection Service
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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?
NARMS Cecal Sampling
United States Department of AgricultureFood Safety and Inspection Service
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NARMS Cecal Sample Percent Positives by Organism and Animal Class
Animal Class Sample Total
Sal + % Pos Campy + % Pos E.coli+ % Pos Enterococcus+
% Pos
Beef Cow 353 31 8.8% 74 21.0% 72 88.9% 63 94.0%
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%
Total 3316 799 24.16% 1219 36.77% 636 94.22% 551 96.50%
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
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NARMS HACCP Sampling and Reporting
United States Department of AgricultureFood Safety and Inspection Service
FSIS Multi Hazard ProjectFSIS 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
United States Department of AgricultureFood Safety and Inspection Service
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FSIS Residue Laboratory Methods
Chemistry Laboratory Guidebook:http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/chemistry-laboratory-guidebook/chemistry-laboratory-guidebook
United States Department of AgricultureFood Safety and Inspection Service
25
Method Capability by Tissue Class, Oct 2013
Product Class →
Beef Pork Poultry Sheep Goat EquineScreening Methods ↓
MRM*multiple drug classes
M, K M, K M, K M**, K** M**, K** M
Aminoglycosides M, K, L M, K, L M, K M**, K** M**, K** MBeta-Agonists M, L M, L L L M**
Phenylbutazone K MCarbadox 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**Slated for inclusion during FY14FY14 2014
M = muscle L = liver K = kidneyP = Processed Products
United States Department of AgricultureFood Safety and Inspection Service
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Chemicals without Tolerances
United States Department of AgricultureFood 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
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Chemicals without Tolerances
United States Department of AgricultureFood Safety and Inspection Service
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Thank You
Questions?
Questions?
United States Department of AgricultureFood Safety and Inspection Service
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CY 2012 Inspector Generated Violations - by Animal Type -
SLTR
CLASS
# OF IN- PLANT TESTS
# OF POSITIVE IN-PLANT
TESTS
# OF VIOLATIVE
ANIMALs# OF
VIOLATIONSVIOLATIVE
COMPOUNDS DETECTED
DAIRY COWS 99,385
2,817
(2.83% of tests)
420
(14.9% of positives)
503
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.
BEEF COWS 19,417
545
(2.81% of tests)
64
(11.74% ofpositives)
82
Penicillin (21); Tilmicosin (13); Oxytetracycline (12); Flunixin (11) Sulfamethazine (10); Florfenicol (9); Ceftiofur (4); Gentamycin (2).
30
CY 2012 Inspector Generated Violations - by Animal Type -
SLTR CLASS
# OF IN- PLANT TESTS
# OF POSITIVE IN-PLANT
TESTS
# OF VIOLATIVE
ANIMALs# OF
VIOLATIONSVIOLATIVE
COMPOUNDS DETECTED
STEERS 11,371216
(1.99% of tests)
31
(14.6% of positives)
40
Gentamycin (8); Ceftiofur (7); Tilmicosin (6); Penicillin (5); Sulfadimethoxine (4); Florfenicol (4); Flunixin (3); Sulfamethazine (3);
HEIFERS 3,717
117
(3.15% of tests)
16
(17.1% ofpositives)
20
Ceftiofur (4); Sulfamethazine (4) Penicillin (3); Gentamycin (2); Neomycin (1); Tilmicosin (1); Flunixin (1); Sulfadimethoxine (1); Florfenicol (1); etc.
31
CY 2012 Inspector Generated Violations - by Animal Type -
SLTR CLASS
# OF IN- PLANT TESTS
# OF POSITIVE IN-PLANT
TESTS
# OF VIOLATIVE
ANIMALs# OF
VIOLATIONSVIOLATIVE
COMPOUNDS DETECTED
Bob Veal Calves
42,755802
(1.88% of tests)
283
(35.15% of positives)
371
Neomycin (188); Sulfamethoxazole (41); Ceftiofur (26); Sulfamethazine (19); Flunixin (19); Sulfadimethoxine (15); Penicillin (13); Oxytetracycline (12); Tilmicosin (9); Gentamycin (5); etc.
Non Formula Fed Veal Calves
1,786
107
(5.99% of tests)
23
(21.5% ofpositives)
27
Neomycin (14); Sulfadimethoxine (4); Gentamycin (4); Tilmicosin (3); Tulathromycin (2); Sulfamethazine (1);Tulathromycin (2).
32
CY 2012 Inspector Generated Violations - by Animal Type -
SLTR CLASS
# OF IN- PLANT TESTS
# OF POSITIVE IN-PLANT
TESTS
# OF VIOLATIVE
ANIMALs# OF
VIOLATIONSVIOLATIVE
COMPOUNDS DETECTED
Sows 10,089189
(1.88% of tests)
62
(35.15% of positives)
78Penicillin (75); Sulfadoxine (1); Ceftiofur (1); Naficillin (1).
Market Hogs
18,074
160
(5.99% of tests)
12
(21.5% ofpositives)
18Sulfamethazine (12); Penicillin (4); Lincomycin (1); Ciprofloxacin (1)
•
Selected 2013 Quarter-1 data comparison*- Dairy Cows -
DistrictNumber
SlaughteredSuspect/
Condemned**HQ
GeneratedSamples
In-Plant KIS tests
ViolationsHQ/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
•
Selected 2013 Quarter-1 data comparison*- Sows -
DistrictNumber
SlaughteredSuspect/
Condemned**HQ
GeneratedSamples
In-Plant KIS tests
ViolationsHQ/IIC
(Antibiotics)
A 100,839 1,703/540
12 23 0/0
B 104,440 337/66 9 1,204 0/3(All penicillin)
C 30,983 1,221/187
15 391 0/6(All penicillin)
* Preliminary data from PHIS ** For disease conditions that are subject to residue tests
•
Selected 2013 Quarter-1 data comparison*- Bob Veal Calves -
DistrictNumber
SlaughteredSuspect/
Condemned**HQ
GeneratedSamples
In-Plant KIS tests
ViolationsHQ/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
* Preliminary data from PHIS ** For disease conditions that are subject to residue tests