Transcript Residue Operations - European Food Safety

Food Safety and Inspection Service
NATIONAL RESIDUE
PROGRAM (NRP)
NRP
presented by
• Dr. Manzoor Chaudry
• Dr. Jim Kile
NATIONAL RESIDUE PROGRAM
NRP
• Prevention of illegal chemical residues in the food
supply is an integral aspect of maintaining a high
level of food safety.
• Is a multi-component analytical testing program
for chemical residues in domestic and imported
products.
• Provides a number of sampling plans to VERIFY
that slaughter establishments and foreign
inspection systems are fulfilling their
responsibilities under HACCP for preventing
violative residues.
NATIONAL RESIDUE PROGRAM
(Continued)
• The NRP is designed to provide:
– A structured process for identifying and
evaluating compounds
– The capability to analyze for compounds of
concern
– Appropriate regulatory follow-up of reports of
violative tissue residues
– Collection, statistical analysis, and reporting of
the results of these activities
NATIONAL RESIDUE PROGRAM
NRP
Goals include:
• Enforcement of Federal laws and regulations
• Act as a deterrent against the slaughter of adulterated
animals and the processing of adulterated eggs
• Maintain consumer confidence by ensuring that meat,
poultry and egg products are not adulterated
• Assess and communicate human exposure to chemical
residues
• Provide verification of residue control in HACCP systems
REGULATORY RESPONSIBILITY
• Food Safety and Inspection Service (FSIS): Testing and
coordinating the efforts of the regulatory agencies to
control residues in meat, poultry, and egg products.
• Food and Drug Administration (FDA): Approval of drug
and feed additive usage's; and establishment of drug
tolerances in meat, poultry, and egg products, and their
enforcement.
• Environmental Protection Agency (EPA): Approval of
pesticides and establishment of their tolerances in meat,
poultry, and egg products.
• Meat Industry : Reduce or eliminate residues in meat,
poultry, and egg products.
NATIONAL RESIDUE PROGRAM
NRP
Potential food safety hazards related to
residues include:
• Animal drugs
• Pesticides
• Environmental contaminants
NATIONAL RESIDUE PROGRAM DESIGN
• Revised on an annual basis
• Compounds are ranked according to
public health risk
• Includes approved and unapproved
compounds in the monitoring program
NATIONAL RESIDUE PROGRAM (Components)
•
•
•
•
•
Domestic Residue Sampling Program
Import Residue Sampling Program
EU Additional Testing
Investigational New Animal Drugs (INAD)
Biologics
DOMESTIC RESIDUE SAMPLING
PROGRAM - (Components)
• Monitoring Plan
– Domestic & Imported Product
• Special Projects
• Surveillance Sampling
• Enforcement Testing
– In-Plant
• Contamination Response System (CRS)
SAMPLING SUMMARY TABLES
Source: 1999 & 2000 FSIS National Residue Program
1999
2000
• Monitoring Plan
• Special Projects
• Import (Port of Entry)
32,280
5,800
8,688
37,480
2,770
7,395
TOTAL
46,751
47,645
MONITORING PLAN
Sampling of specified animal populations to
provide information about the occurrence of
residue violations on an annual, national basis
– statistically based random selection
– from animals that appear normal and healthy at
the time of slaughter
– from animals that have passed inspection
MONITORING PLAN
(Continued)
• Sample Request Forms
• Generation
– Headquarters
• Distribution
– Federally Inspected Plants
– Importing Establishments
– State Inspected Plants
COMPOUNDS in 2000 NRP
• Monitoring Plan:
Arsenicals
Avermectins
Beta Agonists
Sulfonamides
Antibiotics
Flouroquinolones
Carbadox
Tilmicosin
Tranquilizers
CHC/COP
Others
SPECIAL PROJECTS
• Information gathering studies:
– will not be conducted over a full 12-month
period
– used to develop information on frequency and
concentration at which residues occur
– from animals that appear normal and healthy at
the time of slaughter
– from animals that have passed inspection
SPECIAL PROJECTS
(Example)
• Clenbuterol testing
– coordinate testing with the States that conduct
animal fairs
– monitor testing by FSIS in plants slaughtering
show animals
• Other projects
– coordinate within FSIS and states
– phenylbutazone, flunixin
SURVEILLANCE SAMPLING
• Are information gathering studies
• Is designed to:
– distinguish components of a production class in
which residue problems may exist
– measure the extent of the problem
– evaluate the impact of actions taken to reduce
the occurrence of residues in the food animal
population
ENFORCEMENT TESTING
(In-Plant Sampling)
• Obtained from individual animals or lots:
– to detect violative concentrations of residues
from animals that appear suspicious based on
herd history, ante-mortem,, or post-mortem
inspection
– to follow up on producers and others that have
marketed animals with violative levels of
residues
– to verify the industry’s HACCP system
ENFORCEMENT TESTING
(Continued)
• Fast Antimicrobial Screen Test (FAST)
– replacing STOP & CAST tests
– only approved for use in cattle including bobveal calves
– detects both antibiotic and sulfonamide drugs
• Swab Test On Premises (STOP)
– may be used in any species
– if used in calves, all zones are considered
positive and tissues are sent to the lab
– test has little sensitivity for sulfonamides
ENFORCEMENT TESTING
“FAST” & “STOP”
• Presence of significant pathology which would
indicate a likelihood of treatment
• Animals condemned for disease conditions where
treatment was likely
• Injection sites
• Antemortem downers
– Depending on pathology
• Violators with an open residue case
‘FAST’ IN-PLANT TESTS
Source: USDA/FSIS/OPHS/FASD
YEAR
1995
1996
1997
1998
NUMBER VIOLATIONS PERCENT
68,139
156,078
109,021
108,020
804
1,024
472
751
1.18
0.66
0.43
0.70
‘STOP’ IN-PLANT TESTS
Source: USDA/FSIS/OPHS/FASD
YEAR
1995
1996
1997
1998
NUMBER VIOLATIONS PERCENT
83,524
41,995
33,709
37,633
888
292
148
220
1.06
0.70
0.44
0.58
ENFORCEMENT TESTING
‘SOS’
• Sulfa on Site
– Testing-used in market hogs only
– testing protocol-one day per week
– 6 samples per day (one sample per lot not to
exceed 6 lots)
‘SOS’ IN-PLANT TESTS
Source: USDA/FSIS/OPHS/FASD
YEAR
1995
1996
1997
1998
NUMBER VIOLATIONS PERCENT
155,430
15,600
10,072
11.109
43
24
9
28
0.03
0.15
0.09
0.25
ENFORCEMENT TESTING
‘CAST’
• Calf Antibiotic and Sulfonamide Test
• Certified - certification the calf has not been
treated, or treated within FDA label directions
• Noncertified - normal healthy calves selected at
random for testing according to testing level tables
• Others - tested always at 100% and include the
following:
–
–
–
–
suspects
carcasses showing signs of disease or treatment
calves from violators with an open residue case
condemned calves are not tested
‘CAST’ IN-PLANT TESTS
Source: USDA/FSIS/OPHS/FASD
YEAR
1995
1996
1997
1998
NUMBER VIOLATIONS PERCENT
58,197
21,045
11,988
8,958
848
169
55
82
1.46
0.80
0.46
0.92
COMPARISON OF IN-PLANT RESIDUE VIOLATIONS
Source: USDA/FSIS/OPHS/FASD
1.6
1.4
PERCENT
1.2
1
FAST
0.8
STOP
CAST
0.6
SOS
0.4
0.2
0
1995
1996
1997
YEAR
1998
RESIDUE VIOLATIONS
• FSIS Informs FDA:
– Illegal drugs
– Massive violations (over 10X the tolerance)
– Advent of new drugs/codes (e.g. tilmicosin)
• Since FDA has access to the Residue
Violation Information System (RVIS),
exercise good judgement in deciding if
necessary
INVESTIGATIONAL NEW
ANIMAL DRUGS
(INAD)
• Receive initial FDA approval of INAD and enter
in the database
• Receive request from the investigator for slaughter
of animals used in the trial
• Review & prepare slaughter permit
• Will develop and maintain log on INAD
• For Biologic - same as INAD
INVESTIGATIONAL NEW ANIMAL
DRUGS
(INAD; Continued)
• INAD animals under waiver:
– most INAD’s have a waiver granted by FDA under
their agreement with the originating drug company that
any animal going to slaughter more than 30 days
beyond the withdrawal time can be slaughtered as a
non-investigational animal
– no special notifications are involved
– the investigator is not required to notify FSIS of the
slaughter of these animals which fulfill waiver
requirements
IMPORT RESIDUE SAMPLING
PROGRAM
• Countries are required to have inspection systems
equivalent to the U.S.
• Principle of import activities is a ‘systems approach’
– residue control is a major feature of the inspection
system
– are required to have residue control standards
• FSIS randomly samples products for reinspection at
U.S. ports of entry
IMPORT RESIDUE SAMPLING
PROGRAM (Continued)
• Reinspection of products is performance-based
• Residue analysis is not limited to compounds in
the Domestic Residue Program
• Decisions of product acceptability are based on
U.S. tolerances or action levels
PRODUCT DISPOSITION
• TSC staff analyze and interpret test results
• Determine product disposition
• Enforcement Testing samples:
– inform the IIC ASAP
• For Monitoring Plan samples:
– have IIC make inquiry to determine if any
product is still available
FOLLOW-UP ON RESIDUE CASES
• Red Meat
• Poultry
• Certain other selected violations:
– 5 negative animals are required for pre-sampling
followed by 1 negative verification sample
– for a producer, this is generally five (5) consecutive
negative animals
• may be submitted over a period of time
– for middlemen, such as dealers, order buyers,
feedlots, etc.
• fifteen (15) animals are required
• up to 5/week as available
CONTAMINATION RESPONSE
SYSTEM - CRS
Management response system to identify potential
residue crises involving pesticides or other
environmental contaminants
– Such as Dioxin & Alachlor
– Resources utilized by CRS:
•
•
•
•
•
Food and Drug Administration (FDA)
Environmental Protection Agency (EPA)
Animal and Plant Health Inspection Service (APHIS)
State Officials
Agricultural Marketing Service (AMS)
– poultry cases
TOTAL LIVESTOCK SLAUGHTERED
BY YEAR IN U.S.
SOURCE: USDA/FSIS/OPHS/FASD (01-10-01)
160
140
120
100
80
PER MIL
60
40
20
0
1995
1996
1997
1998
1999
2000
Technical Service Center
USDA/FSIS/OFO
Suite 300, Landmark Center
1299 Farnam Street
Omaha, NE 68102
402-221-7400
[email protected]
6am - 6pm CT
INTERNET ADDRESSES
• TSC at FSIS:
http://www.fsis.usda.gov/OFO/TSC/
• Red Book:
http://www.fsis.usda.gov/OPHS/red97/index.htm
• Blue Book:
http://www.fsis.usda.gov/OPHS/blue2000/index.htm
• NRP 2000:
http://www.fsis.usda.gov/OPHS/nrp2000/index.htm