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

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

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




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

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

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

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

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


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


Paired

MultiAnalyses

108
888
888
888


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


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

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




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

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

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








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










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

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

United States Department of
Agriculture







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


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


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








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


Questions?

28

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

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

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

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

- 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

•



- 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


1,221/
187

15

391

0/6
(All penicillin)


- 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
•



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

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