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

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NRP Overview/Changes


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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


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.

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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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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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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


Paired Multi-Analyses

800 samples

Many production

classes

Multiple compounds

1 production class – 300 samples

Single compound

10888888888

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Advantages


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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


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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


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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


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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


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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

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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

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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


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NARMS PARTICIPATION


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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


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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


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.

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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


http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/chemistry-laboratory-guidebook/chemistry-laboratory-guidebook



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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


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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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Thank You

Questions?

Questions?


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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).

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SLTR CLASS



TESTS

# OF VIOLATIVE

ANIMALs# OF

VIOLATIONSVIOLATIVE

COMPOUNDS DETECTED

STEERS 11,371216

(1.99% of tests)

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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)

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Ceftiofur (4); Sulfamethazine (4) Penicillin (3); Gentamycin (2); Neomycin (1); Tilmicosin (1); Flunixin (1); Sulfadimethoxine (1); Florfenicol (1); etc.

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SLTR CLASS



TESTS

# OF VIOLATIVE

ANIMALs# OF

VIOLATIONSVIOLATIVE

COMPOUNDS DETECTED

Bob Veal Calves

42,755802

(1.88% of tests)

283


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)

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Neomycin (14); Sulfadimethoxine (4); Gentamycin (4); Tilmicosin (3); Tulathromycin (2); Sulfamethazine (1);Tulathromycin (2).

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SLTR CLASS



TESTS

# OF VIOLATIVE

ANIMALs# OF

VIOLATIONSVIOLATIVE

COMPOUNDS DETECTED

Sows 10,089189

(1.88% of tests)

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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)

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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


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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)


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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


dr. david goldman - meat/poultry antibiotic residue testing, protecting human health

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