NATIONAL RESIDUE PROGRAM (NRP)

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 PROGRAMNRP 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 PROGRAMNRP 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 19992000 • Monitoring Plan 32,280 37,480 • Special Projects 5,800 2,770 • Import (Port of Entry) 8,688 7,395 TOTAL 46,751 47,645

12. 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

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

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

15. 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 TESTSSource: USDA/FSIS/OPHS/FASD YEARNUMBERVIOLATIONSPERCENT 1995 68,139 804 1.18 1996 156,078 1,024 0.66 1997 109,021 472 0.43 1998 108,020 751 0.70

22. ‘STOP’ IN-PLANT TESTSSource: USDA/FSIS/OPHS/FASD YEARNUMBERVIOLATIONSPERCENT 1995 83,524 888 1.06 1996 41,995 292 0.70 1997 33,709 148 0.44 1998 37,633 220 0.58

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 TESTSSource: USDA/FSIS/OPHS/FASD YEARNUMBERVIOLATIONSPERCENT 1995 155,430 43 0.03 1996 15,600 24 0.15 1997 10,072 9 0.09 1998 11.109 28 0.25

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 TESTSSource: USDA/FSIS/OPHS/FASD YEARNUMBERVIOLATIONSPERCENT 1995 58,197 848 1.46 1996 21,045 169 0.80 1997 11,988 55 0.46 1998 8,958 82 0.92

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.SOURCE: USDA/FSIS/OPHS/FASD (01-10-01)

38. Technical Service Center USDA/FSIS/OFO Suite 300, Landmark Center 1299 Farnam Street Omaha, NE 68102 402-221-7400 Tech.Center@usda.gov 6am - 6pm CT

39. 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

40. That's all Folks!