Update on National Residue Program

Report
P. Bennett, DVM, MS, DACVPM, MPP
Office of Public Health Science
Food Safety and Inspection Service
1

Historical Perspectives

NRP Initiatives
◦ Restructure NRP
◦ Establish public health safety levels
◦ Establish methods framework

Questions
2
To protect consumers from unsafe exposure to chemical
residues in meat, poultry, and egg products
http://www.culinate.com/hunk/29180
3


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
4
1995
FSIS Implementation of Fast Antimicrobial Screen Test
(FAST)
1996
HACCP Implementation
2009
Begin Kidney Inhibition Swab (KIS) Implementation
2011
Begin using Multi-class method for
testing pesticides

2012 Begin using Multi-class method for
testing veterinary drugs
5
NRP Goals
Monitor chemical
exposure in the
industry
Revise residue
sampling &
scheduling
algorithms
Respond to
public and
stakeholder
concern
Develop analytical
techniques and improve
analysis
Improve
documentation of
chemical hazards
Identify trends
and high-priority
compounds to
research
Establish protocol
for recall decisions
6
EPA
FDA
-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
-Improved
coordination
and
communication
between tiers
- Share residue
data, safety
limits, and
analytical
methods
-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
7
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
8
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
9
Restructure
NRP
Establish
methods
framework
Establish
public
health
safety levels
10
New methods
Restructure
NRP
Tiered approach
Hazard ID and
ranking
11
New methods
Restructure
NRP
Tiered approach
Hazard ID and
ranking
12




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
13
MRM: a Significant Improvement
Distinguish
individual
•Chemical method
analytes
Screen many
types of analytes
Screen up to 120+
analytes
• NOT JUST
ANTIBIOTICS
• First time FSIS to use
this type of method
• First time FSIS method
to analyze multiple
chemicals per sample
14
Beta-Agonists
Beta-Lactams &
Cephalosporins
Hormones
Macrolides & Lincosamides
MRM Classes
Analgesics & Antiinflammatory
Phenicols
Fluoroquinolones
Sulfas
Tetracyclines
15
Fluoroquinolone

Desethylene Ciprofloxacin
Norfloxacin
Ciprofloxacin
Danofloxacin
Enrofloxacin
Sarafloxacin




Hormones

Prednisone*



Oxyphenylbutazone (pork only)*
Flunixin
Phenylbutazone (pork only)
Beta/Dexa-methasone*
Tetracycline

Macrolide/Lincosamide
Lincomycin
Pirlimycin
Clindamycin
Gamithromycin*
Tilmicosin
Erythromycin
Tylosin
Analgesic/Antiinflammatory
Oxytetracline
Tetracyline
Chlortetracycline
Phenicol



Florfenicol Amine (pork only)
Florfenicol
Chloramphenicol
* Indicates analytes not tested/not tested in
recent years.
16
Sulfonamide
Sulfanilamide (pork only)*
Sulfadiazine
Sulfathiazole
Sulfapyridine
Sulfamerazine
Sulfamethiazole
Sulfamethazine
Sulfamethoxypyridazine
Sulfachloropyridazine
Sulfadoxine
Sulfamethoxazole
Sulfaethoxypyridazine
Sulfadimethoxine
Sulfaquinoxaline
Sulfanitran*

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.
17

Screening method
◦ Specific screening
◦ Improved sensitivity
◦ Level assessment

Confirmatory method
◦ Multi class method reduces time and need for
class-specific confirmation tests
18
Analytes in the Aminoglycosides Method
Neomycin
Gentamicin
Spectinomycin
Apramycin
Aminoglycosides
Analytes
Dihydrostreptomycin
Hygromycin B
Amikacin
Streptomycin
Kanamycin
19
Benzimidazole
Carbamate
Conazoles/Triazoles
Halogenated
Pesticide Classes
Imidazoles
Organonitrogen
Organophosphates
Pyrethroids
Triazines
20
Benzimidazole
Thiabendazole
Carbamate
Carbaryl
Carbofuran
Methomyl
Organophosphorus
Acephate
Azinphos-methyl
Chlorpyrifos
Chlorpyrifos-methyl
Dichlorvos (DDVP)
Ethofumesate
Tetrachlorvinphos
Organonitrogen
Metalaxyl
Tebufenozide
Pyrethroids
Bifenthrin
Cyhalothrin-L
Cypermethrin
Deltamethrin
Permethrin (cis & trans)
Tefluthrin
Triazines
Simazine
Conazoles / Triazoles
Difenoconazole
Myclobutanil
Propiconazole
Tetraconazole
21
Halogenated
Halogenated
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
◦
Alachlor
Aldrin
Boscalid
Carfentrazone-ethyl
Chlordane, cisChlordane, transClofentezine
Dieldrin
Diflubenzuron
Diuron
Endosulfan I
Endosulfan II
Endosulfan sulfate
Fipronil
Heptachlor
Heptachlor epoxide (cis & trans)
Imidacloprid
Linuron
Nonachlor, transNorflurazon
Oxychlordane
Pronamide
Propachlor
Propanil
Pyridaben
Thiamethoxam
Imidazoles
Imazalil
Other Compounds
Indoxacarb
Methoxyfenozide
Mirex
Piperonyl butoxide
22
Elements in the Metals Method
Lead
Cadmium
Manganese
Metals Elements
Thallium
Selenium
Cobalt
Molybdenum
23
Florfenicol
Florfenicol
*** Tylosin
*** Neomycin
Tilmicosin
*** Tetracycline
*** Oxytetracycline
Desfuroylceftiofur (as DCA or DCCD)
*** denotes 7-plate bioassay
*** Ampicillin
Chloramphenicol
*** Chlortetracycline
*** Penicillin
Arsenic
Ivermectin
Ivermectin
Doramectin
Doramectin
Moxidectin
Moxidectin
Cadmium
Cadmium
Lead
Lead
Flunixin
Flunixin
p,p'-DDE
Mirex
Alpha-BHC
Aldrin
Carbadox
Ractopamine
Sulfathiazole (SUL2)
Sulfamethazine (SUL2)
Sulfadimethoxine (SUL2)
Sulfamethoxazole (SUL)
Sulfadiazine (SUL)
Sulfathiazole (SUL)
Sulfamethazine (SUL)
Sulfadimethoxine (SUL)
Relative %
MU (normalized) for quantitative
FSIS CLG methods
180
140
100
60
20
24


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_Gui
debook/index.asp
25
FSIS Method Implementation:
Proposed Timetable
• MRM method: Targeted sampling
2012
2013
• Aminoglycosides Method: Scheduled and Targeted
sampling programs
• Metals method: Exploratory program
• MRM as a screening method in Eastern and Western labs
for Scheduled sampling program
26
New methods
Restructure
NRP
Tiered approach
Hazard ID and
ranking
27

Scheduled Sampling Program
◦ Headquarters generated
◦ Across production classes

Targeted Sampling Program
◦ (Field)Inspector generated
◦ Directed at a particular plant/production
class/chemical
◦ Focused
28
Tier 1 – Scheduled Sampling:
Appropriate Methods
Violative
Residues
May direct sample
for Tier 2 Testing
Violative
Residues
May direct sample
for Tier 3 Testing
Violative
Residues
Additional testing
Tier 2 – Targeted Sampling:
Appropriate Methods
Tier 3 – Targeted Flock/Herd:
Appropriate Methods
29
New methods
Restructure
NRP
Tiered approach
Hazard ID and
ranking
30
Define the Universe of
Chemical Hazards
Screen to Establish a Priority List
Risk Based Priority List
Select compounds from Priority List
Determine appropriate
Public Health Safety Level
Enter into scheduling algorithm
National Residue Program
Risk Management
31
Restructure
NRP
Establish
methods
framework
Establish
public
health
safety levels
32
Developing
policies
Peer
Review
FDA
Input
Methodology
to determine
PH safety
levels
33
Restructure
NRP
Establish
methods
framework
Establish
public
health
safety levels
34



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
35
The NRP initiatives will result in:
Identify emerging
contaminants
Prevent
adulterated meat,
poultry, and egg
products from
entering the
marketplace
http://www.quicklabel.com/blog/wp-content/uploads/2011/07/iStock_000011997708Small.jpg
Discourage
improper
behavior by
producers,
processors, and
importers
Close regulatory
gaps between
Agencies
http://media.treehugger.com/assets/images/2011/10/cute-kid-eating-meat-steakphoto.jpg
36

Terry Dutko

Vivian Chen

Patricia Nedialkova

David Goldman

Lynn Cruikshank

Allie Miraglia

Lou Bluhm

Margaret O’Keefe

Emilio Esteban

Naser Abdelmajid

Sarah Edwards

David LaBarre

Janell Kause

Alex Domesle

Alice Thaler

Jade Mitchell-Blackwood

Pat Basu

Kerry Dearfield
37
Patty Bennett
[email protected]
202-690-6189
38

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