1,552
(15.4% of
tests)
Market
Hogs
Heavy
Calves
# OF
VIOLATIVE
ANIMALs
# OF
POSITIVE
IN-PLANT
TESTS
# OF INPLANT
TESTS
SLTR
CLASS
128
(8.24% of
positives)
199
The document discusses antibiotic residue testing in meat and poultry by the USDA to protect human health. It provides an overview of the National Residue Program, including improvements made to increase annual sampling and use multi-residue screening methods. Preliminary data from the program in 2013 found violative
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Dr. David Goldman - Meat/Poultry Antibiotic Residue Testing, Protecting Human Health
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. 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
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. 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. 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. 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
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. United States Department of Agriculture
Food Safety and Inspection Service
Paired
MultiAnalyses
108
888
888
888
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. 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. 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
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
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. 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
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
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. 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
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
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
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. 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. 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. 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. 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. 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. 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
Hinweis der Redaktion
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
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?