FDA Tissue Residue Reduction Efforts

1. FDA Tissue Residue Reduction Efforts Deborah A. Cera Office of Surveillance and Compliance Center for Veterinary Medicine (301)827-0181

2. Food & Drug Administration • Center for Veterinary Medicine • Center for Food Safety and Applied Nutrition • Center for Drug Evaluation and Research • Center for Devices and Radiological Health • Center for Biologics Evaluation and Research • National Center for Toxicological Research

3. Atlanta (GA,NC,SC) Florida (FL) New Orleans (AL,LA,MS,TN) San Juan (PR) Dallas (AR,OK,TX) Denver (CO,NM,UT,WY) Kansas City (IA,KS,MO,NE) Los Angeles (CA(Southern),AZ) San Francisco (CA(Northern),HI,NV) Seattle (AK,ID,MT,OR,WA) New England (CT,ME,MA,NH,RI,VT) New York (NY) Baltimore (DC,MD,VA,WV) Chicago (IL) Cincinnati (KY,OH) Minneapolis (MN,ND,SD,WI) New Jersey (NJ) Philadelphia (DE,PA) Detroit (IN, MI) FDA District Offices

4. TRULY A COOPERATIVE EFFORT!

5. Memoranda of Understanding • Food and Drug Administration (FDA) • Food Safety and Inspection Service (FSIS) • Environmental Protection Agency (EPA)

6. other Federal Partners • Centers for Disease Control • Agricultural Research Service • Animal Plant Health Inspection Service • Agricultural Marketing Service • Grain Inspection Packers and Stockyards Administration

7. Memoranda of Understanding Partnership Agreements Contracts Informal Agreements State Partners

8. STATE COOPERATIVE AGREEMENTS MEMORANDA OF OTHER CONTRACTS UNDERSTANDING AGREEMENTS Vermont Delaware AlabamaNew York Pennsylvania TennesseeMaryland Virginia North Carolina Ohio West Virginia IndianaKentucky Georgia MinnesotaNew Jersey South Carolina MissouriLouisiana MississippiMichiganNorth DakotaSouth DakotaWisconsinTexasIowaKansasNebraskaCaliforniaWashingtonOregon

9. The Most Important Element of a Successful National Program is Communication

10. Databases • Residue Violation Information System (RVIS) • Tissue Residue Information Management System (TRIMS)

11. Residue Violation Information System (RVIS)

12. Tissue Residue Information Management System (TRIMS)

13. Attachment C Data Gathering Tool This Information is Entered into the TRIMS Database

14. Withdrawal Time Not Followed Exceeded Approved Dosage/Treatment (Extra-Label Use) Medication/Treatment Records Not Maintained Calves Fed Colostrum Containing Residue Drugs Given or Fed by Mistake Poor Medicated Feed GMP’s TRIMS - Traditional Causes of Residues

15. Livestock Being Raised for Food Use are “Food” Under the Federal Food, Drug, and Cosmetic Act

16. CVM Compliance Program Activities Illegal Drug Residues in Meat and Poultry

17. Program Objectives • Determine the cause of the illegal drug residue(s). • Develop data descriptive of on-farm practices of management and animal drug use. • Obtain correction through voluntary and/or enforcement actions.

18. Investigative Priorities Repeat Violators First Time Violators

19. First-Time Violations • Drugs Prohibited from Extra Label Use • Residues Detected at a Toxicologically Significant Level • Drugs Not Approved in Food Animals, etc. • Contamination Response System Violations • Low-Level Antibiotic Residues

20. Health Hazards • Acute • Chronic • Intestinal Microflora

21. Investigation of Food Animal Marketing Firms Dealers/Haulers/Auctions

22. Directed Compliance Assignments

23. Tissue Residue Investigations Pasteurized Milk Ordinance Inspections Other Federal Agencies, i.e., Customs, AMS, FSIS, etc. State Regulatory Authorities Drug Experience Reports Agricultural Drug Marketing Data Trade Shows& Professional Meetings Complaints by Veterinarians and Academia Informants Surveillance Information

24. RVIS Activities Requesting Analytical Work Assigning Investigations Reviewing Completed Establishment Inspection Reports Submitting Paperwork Updating District Mgmt. Distributing Educational Materials Maintaining Communications District Program Monitors

25. Program Interaction

26. Analytical • FSIS • FDA • National Center for Toxicological Research

27. Elements of FDA Case • Jurisdiction • Violation • Responsibility

28. Documentation of Violation • Drug Inventory • Drug Storage Practices • Drug Administration Practices • Medication/Treatment Records • Withdrawal Time Adherence • Fraudulent Buying or Selling Practices

29. Dealer Involvement • Describe Dealer System for Documenting the Following: • Animal Identification • Medication Status Inquiry • Withholding Practices

30. Veterinary Involvement • Veterinarian/Client/Patient Relationship • Establishment of Withdrawal Time • Producer Adherence to Withdrawal Time • Labeling • Compounding Practices

31. Enforcement Remedies • Warning Letter • Injunction • Seizure • Prosecution • Import Alert • State/Local Enforcement

32. Warning Letter Issuance • Repeat Violations • First-Time Violations • High Risk Residues • High-Level Residues • Residues Caused by Extra-Label Use by Laymen

33. Injunction • Consider Once a Warning Letter Has Been Issued.

34. Prosecution • AMDUCA Prohibited • Unapproved Drugs • Blatant Misuse • Issuance of False Guarantee • Multiple Misdemeanor Counts • One or More Felony Counts

35. PROCESS SUMMARY • FSIS Collects the Sample Along with All Manmade ID • FSIS/FDA Analyzes the Sample • Preliminary Residue Data is Entered Into RVIS • FSIS Traces Back Residue and Enters All Parties Involved in Residue Into RVIS • FSIS Issues Violator Warning Letter • FDA District Receives Weekly Violator Report from RVIS • FDA Assigns Residue to State/FDA for Investigation • Investigation is Conducted • RVIS is Updated • FDA/State Enforcement Action is Taken as Appropriate • TRIMS is Updated • Firm Submits 5/15 Residue-Free Animals and Case is Closed

36. Extra Label Drug Use • Species • Indication • Dosage • Withdrawal Time

37. Animal Medicinal Drug Use Clarification Act • AMDUCA • Purpose

38. Valid VCPR • Veterinarian has assumed responsibility • Client agrees to follow instructions • Sufficient knowledge of the animal(s) • Readily available for follow-up

39. Conditions for extra-label drug use in food-producing animals: • No approved new animal drug • Prior to prescribing or dispensing: • Make careful diagnosis and evaluation • Establish withdrawal period • Maintain identity of treated animal • Assure withdrawal times are met/no illegal residues

40. ELU is not permitted: • By lay persons-except under vet supervision • In/on an animal feed • Results in an illegal residue

41. ELU of a Human or Vet drug Approved for Non-Food Animals: • Appropriate medical rationale • Human food safety measures • Does not permit ELU of a human drug if there is an approved vet drug

42. Veterinary Records: • Name of the drug • Condition • Species • Dosage • Duration • Number • Withdrawal

43. ELU Labeling Shall Include: • Vet name & address • Pharmacy name & address • Drug name • Directions for use • Cautionary statements • Withdrawal times

44. AMDUCA Does Not Permit: • ELU advertising or promotion • ELU of certain drugs prohibited from use in food animals • ELU of drugs for non-therapeutic uses • ELU of drugs in feed

45. Drugs Currently Prohibited from ELU • Chloramphenicol • Clenbuterol • Diethylstilbestrol • Dimetridazole • Ipronidazole • All Other Nitroimidazoles • Furazolidone(except for approved topical use) • Nitrofurazone(except for approved topical use) • Sulfonamide Drugs in Lactating Dairy Cattle(except for approved uses of sulfadimethoxine, sulfabromomethazine, sulfaethoxypyridazine) • Fluoroquinolones • Glycopeptides

46. 21 CFR Parts 500 to 599 • Available from the Government Printing Office: • (202)512-1800 credit • (202)512-2233 fax • P.O. Box 371954, Pittsburgh, PA 15250-7954

47. Check CVM’s Website for the most current information www.fda.gov/cvm