1. Food Safety and Inspection Service NATIONAL RESIDUE PROGRAM (NRP)

2. National Residue Program
NRP
presented by
Dr. Manzoor Chaudry
Dr. Jim Kile

3. 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.

4. 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

5. 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

6. 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.

7. NATIONAL RESIDUE PROGRAM NRP
Potential food safety hazards related to
residues include:
Animal drugs
Pesticides
Environmental contaminants

8. 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

9. NATIONAL RESIDUE PROGRAM - (Components)
Domestic Residue Sampling Program
Import Residue Sampling Program
EU Additional Testing
Investigational New Animal Drugs (INAD)
Biologics

10. DOMESTIC RESIDUE SAMPLING PROGRAM - (Components)
Monitoring Plan
Domestic & Imported Product
Special Projects
Surveillance Sampling
Enforcement Testing
In-Plant
Contamination Response System (CRS)

11. SAMPLING SUMMARY TABLES Source: 1999 & 2000 FSIS National Residue Program
Monitoring Plan 32, ,480
Special Projects 5, ,770
Import (Port of Entry) 8, ,395
TOTAL , ,645

12. MONITORING PLAN statistically based random selection
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

13. MONITORING PLAN (Continued)
Sample Request Forms
Generation
Headquarters
Distribution
Federally Inspected Plants
Importing Establishments
State Inspected Plants

14. COMPOUNDS in 2000 NRP Monitoring Plan: Arsenicals Carbadox
Avermectins Tilmicosin
Beta Agonists Tranquilizers
Sulfonamides CHC/COP
Antibiotics Others
Flouroquinolones

15. Information gathering studies:
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

16. 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

17. 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

18. 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

19. ENFORCEMENT TESTING (Continued)
Fast Antimicrobial Screen Test (FAST)
replacing STOP & CAST tests
only approved for use in cattle including bob-veal 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

20. 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

21. ‘FAST’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD
YEAR NUMBER VIOLATIONS PERCENT ,
, , , ,

22. ‘STOP’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD
YEAR NUMBER VIOLATIONS PERCENT , , , ,

23. 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)

24. ‘SOS’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD
YEAR NUMBER VIOLATIONS PERCENT , , ,

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

26. ‘CAST’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD
YEAR NUMBER VIOLATIONS PERCENT , , , ,

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. TOTAL LIVESTOCK SLAUGHTERED BY YEAR IN U. S
TOTAL LIVESTOCK SLAUGHTERED BY YEAR IN U.S. SOURCE: USDA/FSIS/OPHS/FASD ( )

38. Technical Service Center
USDA/FSIS/OFO
Suite 300, Landmark Center
1299 Farnam Street
Omaha, NE
6am - 6pm CT

39. INTERNET ADDRESSES TSC at FSIS: http://www.fsis.usda.gov/OFO/TSC/
Red Book:
Blue Book:
NRP 2000:
First is internet site address for the TSC.
“Red Book” is the NRP Domestic Residue Databook, pertinent to 1997.
“Blue Book” is the description of the different NRP programs, agencies involved, and various residue compound information.
“NRP 2000” are the data summary tables of various sampling programs for the year.

40. That's all Folks!