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Update: National Residue Program
P. Bennett, DVM, MS, DACVPM, MPPOffice of Public Health Science
Food Safety and Inspection Service
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Historical Perspectives
NRP Initiatives◦ Restructure NRP◦ Establish public health safety levels◦ Establish methods framework
Questions
Outline
3
NRP Mission StatementTo protect consumers from unsafe exposure to chemical
residues in meat, poultry, and egg products
http://www.culinate.com/hunk/29180
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History of the NRP
1967-8 Wholesome Meat and Poultry Acts 1975-1984 Memorandums of Understanding: Give authority to
Surveillance Advisory Team (SAT) & Interagency Residue Control Group (IRCG)
1979 Implementation of Swab Test on Premises (STOP)
1980 First Compound Ranking System 1981 FDA executes first successful prosecution
as a result of STOP
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1995 FSIS Implementation of Fast Antimicrobial Screen Test (FAST)
1996 HACCP Implementation2009 Begin Kidney Inhibition Swab (KIS) Implementation2011 Begin using Multi-class method for
testing pesticides 2012 Begin using Multi-class method for
testing veterinary drugs
History of the NRP
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NRP GoalsRevise residue
sampling & scheduling algorithms
Improve documentation
of chemical hazards
Identify trends and high-priority
compounds to research
Establish protocol for
recall decisions
Develop analytical techniques and
improve analysis
Respond to public and
stakeholder concern
Monitor chemical
exposure in the industry
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Collaborative Efforts
-Manages farm-to-fork testing and feed analysis
-Conducts on-farm
investigations
-Prevents violations through testing and regulatory action
-Enforces the tolerances of animal drugs in meat, poultry, and egg products and prevents improper use of these drugs on farm
-Provides data for continuous baseline sampling
-Uses residue data to
adjust or establish tolerances and safety limits
-Regulates the use of pesticides through establishment of tolerances in meat, poultry and egg products and prevents improper use of these chemicals
FDA EPA
-Improved coordination
andcommunicatio
n between tiers
- Share residue data, safety limits, and analytical
methods
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Collaborative Efforts
MOU: Memorandum of Understanding:• Working relationship
between FSIS, AMS, FDA, EPA to coordinate regulatory activities for residues
• FSIS consults mainly with FDA/EPA to compare information on regulations
IRCG: Interagency Residue Control Group:• FSIS/FDA/EPA/AMS/
CDC/ARS; monthly meetings for updates and collaborating relative to the NRP
SAT: Surveillance Advisory Team:• Interagency
committee that determines the chemical compounds and production classes of public health concern
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Why propose new initiatives?
To minimize risks to consumers from chemical hazards
To “catch the next melamine” and detect new hazards
To more efficiently collect necessary residue data for risk assessments
To develop NRP processes that are easily translated for smooth import and export
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NRP Initiatives
Restructure NRP
Establish public health safety levels
Establish methods
framework
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Modern approach to residue testing Collaboration with Agricultural Research
Service
FSIS labs received new methods in 2011 The MRM methods be implemented as part
of overall improvements to NRP
Multi-Residue Method (MRM)
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Distinguishindividualanalytes
Screen many types of analytes
First time FSIS method to analyze multiple chemicals per sample
Screen up to 120+ analytes
NOT JUST ANTIBIOTICSFirst time FSIS to use this type of method
MRM: a Significant Improvement
• Chemical method
MRM ClassesMRM ClassesBeta-Agonists
Beta-Lactams & Cephalosporins
Hormones
Macrolides & Lincosamides
Analgesics & Anti-inflammatory
Phenicols
Fluoroquinolones
Sulfas
Tetracyclines
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Analytes in the MRM Classes
FluoroquinoloneDesethylene CiprofloxacinNorfloxacinCiprofloxacinDanofloxacinEnrofloxacinSarafloxacin
HormonesPrednisone*
Macrolide/LincosamideLincomycinPirlimycinClindamycinGamithromycin*TilmicosinErythromycinTylosin
Analgesic/Anti-inflammatory
Oxyphenylbutazone (pork only)*
Flunixin Phenylbutazone (pork only) Beta/Dexa-methasone*
Tetracycline Oxytetracline Tetracyline Chlortetracycline
Phenicol Florfenicol Amine (pork only) Florfenicol Chloramphenicol
* Indicates analytes not tested/not tested in recent years.
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Analytes in the MRM Classes
SulfonamideSulfanilamide (pork only)*SulfadiazineSulfathiazoleSulfapyridineSulfamerazineSulfamethiazoleSulfamethazineSulfamethoxypyridazineSulfachloropyridazineSulfadoxineSulfamethoxazoleSulfaethoxypyridazineSulfadimethoxineSulfaquinoxalineSulfanitran*
β-Agonist Salbutamol Cimaterol Ractopamine
Β-Lactam/ Cephalosporin
Cefazolin DCCD Ampicillin Difloxacin Penicillin G Oxacillin Cloxacillin Nafcillin Dicloxacillin
* Indicates analytes not tested/not tested in recent years.
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Screening method◦ Specific screening◦ Improved sensitivity◦ Level assessment
Confirmatory method◦ Multi class method reduces time and need for
class-specific confirmation tests
Impact of MRM
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Aminoglycosides AnalytesNeomycin
Gentamicin
Spectinomycin
Apramycin
Dihydrostreptomycin
Hygromycin B
Amikacin
Streptomycin
Kanamycin
Analytes in the Aminoglycosides Method
Pesticide ClassesPesticide Classes
Benzimidazole
Carbamate
Conazoles/Triazoles
Halogenated
Imidazoles
Organonitrogen
Organophosphates
Pyrethroids
Triazines
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BenzimidazoleThiabendazole
CarbamateCarbarylCarbofuranMethomyl
Organophosphorus Acephate
Azinphos-methylChlorpyrifosChlorpyrifos-methyl Dichlorvos (DDVP) EthofumesateTetrachlorvinphos
Organonitrogen Metalaxyl Tebufenozide
Pyrethroids Bifenthrin Cyhalothrin-L Cypermethrin Deltamethrin Permethrin (cis & trans) Tefluthrin
Triazines Simazine
Conazoles / Triazoles Difenoconazole Myclobutanil Propiconazole Tetraconazole
Analytes in the Pesticide Classes
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Halogenated◦ Alachlor ◦ Aldrin ◦ Boscalid ◦ Carfentrazone-ethyl ◦ Chlordane, cis- ◦ Chlordane, trans- ◦ Clofentezine ◦ Dieldrin ◦ Diflubenzuron ◦ Diuron ◦ Endosulfan I ◦ Endosulfan II ◦ Endosulfan sulfate ◦ Fipronil ◦ Heptachlor
HalogenatedHeptachlor epoxide (cis & trans)Imidacloprid Linuron Nonachlor, trans- Norflurazon Oxychlordane Pronamide Propachlor Propanil Pyridaben Thiamethoxam
Imidazoles
Imazalil
Other Compounds Indoxacarb
Methoxyfenozide
Mirex
Piperonyl butoxide
Analytes in the Pesticide Classes
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Metals ElementsLead
Cadmium
Manganese
Thallium
Selenium
Cobalt
Molybdenum
Elements in the Metals Method
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Sulfa
dimeth
oxine (
SUL)
Sulfa
methazi
ne (SU
L)
Sulfa
thiazole
(SUL)
Sulfa
diazine (
SUL)
Sulfa
methoxa
zole
(SUL)
Sulfa
dimeth
oxine
(SUL2
)
Sulfa
methazi
ne (SU
L2)
Sulfa
thiazole
(SUL2
)
Ractopam
ine
Carbad
ox
Aldrin
Alpha-BHC
Mirex
p,p'-DDE
Flunixi
n
Flunixi
n Lea
d Lea
d
Cadmium
Cadmium
Moxidecti
n
Moxidecti
n
Doramecti
n
Doramecti
n
Iverm
ectin
Iverm
ectin
Arsenic
*** P
enicil
lin
*** C
hlortetra
cyclin
e
Chloramphen
icol
*** A
mpicillin
Florfe
nicol
Florfe
nicol
Desfuro
ylceft
iofur (as
DCA or DCCD)
*** O
xytet
racycl
ine
*** T
etracy
cline
Tilmico
sin
*** N
eomyci
n
*** T
ylosin
20
60
100
140
180
MU (normalized) for quantitative FSIS CLG methods
Rela
tive
%
*** denotes 7-plate bioassay
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Methods for the analysis of food composition, food additives, nutrients, veterinary drug and pesticide residues.
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/Science/Chemistry_Lab_Guidebook/index.asp
Chemistry Laboratory Guidebook
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2012 •MRM method: Targeted sampling •Aminoglycosides Method: Scheduled and Targeted sampling programs•Metals method: Exploratory program
2013 •MRM as a screening method in Eastern and Western labs for Scheduled sampling program
FSIS Method Implementation:
Proposed Timetable
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Scheduled Sampling Program◦ Headquarters generated◦ Across production classes
Targeted Sampling Program◦ (Field)Inspector generated◦ Directed at a particular plant/production
class/chemical◦ Focused
National Residue Program
3-Tiered Model
May direct samplefor Tier 3 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
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Additional testing
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Hazard IDand Ranking
Define the Universe of Chemical Hazards
Screen to Establish a Priority List
National Residue Program
Enter into scheduling algorithm
Risk Management
Risk Based Priority List
Select compounds from Priority List
Determine appropriatePublic Health Safety Level
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NRP Initiatives
Restructure NRP
Establish public health safety levels
Establish methods
framework
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Developing
policies
Methodology
to determine PH safety levels
Public Health Safety Levels -Cadmium
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NRP Initiatives
Restructure NRP
Establish public health safety levels
Establish methods framewor
k
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FDA/FSIS collaboration
Develop a process to expedite approval of new testing methodologies for FSIS.
Develop a comparison protocol to facilitate using new analytical methods while retaining the linkage to the safety package prepared to support the new animal drug approval
Performance-based methods
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Conclusions
The NRP initiatives will result in:
Identify emerging
contaminants
Prevent adulterated meat, poultry, and egg products from entering
the marketplace
Discourage improper behavior by
producers, processors, and importers
Close regulatory gaps between
Agencies
http://www.quicklabel.com/blog/wp-content/uploads/2011/07/iStock_000011997708Small.jpghttp://media.treehugger.com/assets/images/2011/10/cute-kid-eating-meat-steak-photo.jpg
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Terry Dutko
Patricia Nedialkova
Lynn Cruikshank
Lou Bluhm
Emilio Esteban
Sarah Edwards
Janell Kause
Alice Thaler
Pat Basu
Kerry Dearfield
Vivian Chen
David Goldman
Allie Miraglia
Margaret O’Keefe
Naser Abdelmajid
David LaBarre
Alex Domesle
Jade Mitchell-Blackwood
Acknowledgements