2. USDA, Food Safety and Inspection Service Food Safety and Antimicrobial Residues in Food Animals B. P. Dey. DVM, Ph.D. USDA, FSIS, AEPFS Washington, D.C. & Edna Negron, Ph.D. University of Puerto Rico, Mayaguez

3. USDA, Food Safety and Inspection Service Food Safety (Definition) U.S. Department of Health and Human Services Public Health Service Food and Drug Administration 1999 Food Code **************** (27) "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

4. USDA, Food Safety and Inspection Service Food Safety (Definition) A suitable product which when consumed orally either by a human or an animal does not cause health risk to consumer.

5. USDA, Food Safety and Inspection Service How Safe is Food (Meat) Increased Food Borne Illnesses of 1980’s National Research Council (Food Nutrition Board) Scientific Basis of the USDA’s Meat and Poultry Inspection Program (Risk Assessment Approach)

6. USDA, Food Safety and Inspection Service Pathogen Reduction/Hazard Analysis & Critical Control Points System Pathogen Reduction/Hazard Analysis & Critical Control Points System PR/ HACCP Final Rule (9 CFR Chapter III) July 1996

7. USDA, Food Safety and Inspection Service PR/HACCP Preamble PR/HACCP Preamble Overall Food Safety Strategy Regulatory Reform Flexibility and Encourage Industry Involvement Farm-To-Table Approach

8. USDA, Food Safety and Inspection Service Pathogen Reduction/Hazard Analysis & Critical Control Points System Pathogen Reduction/Hazard Analysis & Critical Control Points System 1. Standard Sanitation Operating Procedure (SSOP) 2. Pathogen Reduction a. E.coli Testing b. Salmonella (Performance Standard) Testing 3. Hazard Analysis Critical Control Points (HACCP)

9. USDA, Food Safety and Inspection Service Food Safety Hazard (Unsafe for Human Consumption) Biological (Bacteria, Viruses, Protozoa, BSE (?) ) Physical Chemical (Agricultural Chemicals /Animal Drugs and Environmental Contaminants )

10. USDA, Food Safety and Inspection Service Food Safety Problem Food Safety Problem Farm -To-Table Continuum Hazard at Production, Distribution or Consumption

11. USDA, Food Safety and Inspection Service Concept of Farm-to-Table Food Safety. IN Safe Raw Food Product for Production OUT Safe Processed Food Product Result Safe Food On Table

12. USDA, Food Safety and Inspection Service Challenges Adulteration Organoleptic Examination Farm-To-Table Strategy

13. USDA, Food Safety and Inspection Service Chemical Residues Chemical Residues Growth Promotants Arsenicals, Antibiotics, Clenbuterol Drugs Antimicrobials (Antibiotics, sulfonamides, coccidiostat, anthelmentics, carbadox, phenylbutazone, Halafuginone Insecticide Chlorinated Hydrocarbons and organophosphates

14. USDA, Food Safety and Inspection Service Antibiotics Antibiotics are chemicals substances which has the capacity to inhibit the growth of microorganism or destroy them BacitracinHygromycinStreptomycin ChlortetracyclineNeomycin Tetracycline ErythromycinNovobiocinTilmicosin FlavomycinOxytetracyclineTylosin Gentamycin Penicillin FSIS analyzed 7,834 Domestic monitoring & Special project samples in 2000

15. USDA, Food Safety and Inspection Service SULFONAMIDES Sulfonamides are drugs with bacteriostatic activity used as feed additives and for treating infections. Sulfabromomethazine SulfaguanidineSulfaphenazole Sulfacetamide Sulfamerazine Sulfapyridine Sulfachlorpyridazine Sulfamethazine Sulfaquinoxaline Sulfadiazine Sulfamethizole Sulfasalazine Sulfadimethoxine Sulfamethoxazole Sulfathiazole Sulfadoxine Sulfamethoxypyridazine Sulfatroxazole Sulfaethoxypyridazine Sulfanilamide Sulfisoxazole FSIS analyzed 6,623 Domestic Monitoring and Special Project samples in 2000

16. USDA, Food Safety and Inspection Service Why Prevent Antibiotic Residue in Meat? Immediate Effect - Anaphylactic reaction - Allergy Delayed Effect -Drug resistant organism - Therapy failure -Economics - Impact on immune response

17. USDA, Food Safety and Inspection Service Why Antimicrobial Residue Occurs 1. Shot gun Therapy 2. Illegal Use 3. Excess Use 4. Improperly Prepared/labeled Feed 5. Non Observance of Drug Withdrawal time

18. USDA, Food Safety and Inspection Service FSIS Regulated Product & Action Violative & Illegal Drugs and Chemicals Processor held Responsible for Chemicals Processor Asking Producer to Supply th Risk-free Raw Product

19. USDA, Food Safety and Inspection Service Screen Tests For Detecting Antibiotics in Animal products Meat: 1. Swab Test on Premises (STOP) 2. Calf Antibiotic and Sulfonamide Test (CAST) 3. Fast Antibiotic and SulfonamideTest (FAST) Milk: 1. Charm Test Live Animals 1. None

20. USDA, Food Safety and Inspection Service Antibiotic Violations in Meat: 2000 FSIS Domestic Residue Plan Monitoring Enforcement ProductionClass % Violations% Violations Bulls 0.012 Beef cows 0.310 Dairy cows 1.0 19 Bob veal calves 1.9 NS Heifers 1.98 Steers 0.811 Roaster pig3.2NS Market Hog0.85 Sows2.111 Boar /stags1.6 NS

21. USDA, Food Safety and Inspection Service Sulfonamide Violations in Meat Monitoring Enforcement Production Class % Violations % Violations Bulls 0.0 12 Beef cows 0.3 10 Dairy cows 1.0 19 Bob veal 1.90 Market Hog0.8 5 Bora/Stags1.6 NS Roaster Pig3.2NS Sows2.111

22. USDA, Food Safety and Inspection Service Rate of Residue Violations In Puerto Rico Total Samples Violations/ Rate(%) YearCattle Calves Swine Cattle Calves Swine 199914116419 32 (23) 0 0 200015014711 43 (29) 1 (1) 0 200199130 14 18 (18) 0 0 _________ Total Violations : Cattle: 70 (Antibiotics-68; Sulfonamide-1; CHC-1) Calf-1 (Antibiotics)

23. USDA, Food Safety and Inspection Service Approach & Concerns in Residue Control Approach & Concerns in Residue Control Rethinking in a HACCP environment Sample for certain chemicals in certain establishment Verification

24. USDA, Food Safety and Inspection Service Food Safety Organizations American Food Safety Institute: Training in food safety handling. Arcoplast: Contamination control training for industry. Environmental Outcomes: Training for foodservice and hospitality industries. Food Chemical News: Newsletter for food safety regulations/legislation/ enforcement etc. Food Safety 2000: Multimedia-based training program. Food Safety Resources: Information & training on FDA food code. Hi-Tech Detergents Ltd - manufacturer/designer of detergents, sanitisers, and animal remedies.

25. USDA, Food Safety and Inspection Service Residue Avoidance Activity Residue Avoidance Activity Food Safety and Inspection Service State Producer Groups Universities Industrial Organizations Consumer Group

26. USDA, Food Safety and Inspection Service Residue Control in HACCP Environment FOLLOW NAS GUIDELINE Frame work for control of chemical hazard Consideration of management of chemical hazard HACCP

27. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice #1 Keep medication record for at least 12 months following marketing of any medicated livestock How? - Individually-By Group-By Pen Tool for Identification - Sow Card -Paint -Ear Tags -Ear Notch -Tatoo-Micro(Bio) Chips-

28. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice #2 Maintain Medication and Production Records 1. Routine Vaccination Protocol 2. Use of Medication to prevent Disease (Shipping, Change in Weather) and Stress of Mixing 3. Use of Animal Health products in breeding herd 4. Use of feed additive in finisher unit 5. Routine Treatment Plan -

29. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice #3 Properly Store, Labels, and Account for All Drugs Products and Medicated Feed. Follow labels directions for storage and use Effectiveness (dose) - Storage Temperature (refrigeration) - Administration (Route) - Precaution - Warning (Withdrawl time to market) - Expiration Date Inventory Control and Storage - Storage of Feed and water additives, use of syringes - Separation of medication from Farm Chemicals - Condition of a medicant

30. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 4 Valid Veterinarian/ Client / Patient Relationship 1. Who is responsible for making medical judgement? 2. Regular visits by a veterinarian 3. Commitment by veterinarian

31. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 5 Administering Medications a. Injection Routes (IM /SQ /IP/ IV/ IN) Needle Usage b. Water ( Availability of non medicated water after administration of medicated water)

32. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 6 HACCP Compatible Production Practice # 6 Commercial Feed processors Procedure Feed Manufacturer –Meet specification for nutritional composition –Meet desired medication level –Free of contamination

33. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 7 HACCP Compatible Production Practice # 7 On Farm Feed Processing Buildings and Grounds (House keeping, space, preventive maintenace and storage of medicated feed) Equipment (Suitable, Capable, Cleaning, Accuracy) Work Space and Storage Area (work place and storage design, and separation areas) Product Quality Assurance (Laboratory assay, Equipment Cleaning) Labeling (Proper handling and storage of medications and labels) Record Keeping( Visual inspection, Written records, Retain records, storage of sample of finished feed for 6 months)

34. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 8 Drug Residue Testing When Appropriate a. Culled Animal For Sale b. Animal received extra label treatment c. Roaster Pigs/ Steers d. Exhibiting at Livestock Stock Shows and Fairs e. Other special situations (Accidental spill/Exposure)

35. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 9 HACCP Compatible Production Practice # 9 Establish and Implement Effective Herd Health management plan Check for Disease Observe herd with veterinarian Perform test for disease exposure Conduct Post Mortem following diagnostic procedure Conduct Slaughter Checks Review Production record “BIOSECURITY”

36. USDA, Food Safety and Inspection Service HACCP Compatible Production Practice # 10 HACCP Compatible Production Practice # 10 Code of Practice for Food Animal producers Proper Facility to Protect and Shelter Animals Well Kept facility to allow Safe, Humane and efficient Movement of Animals Trained personnel to take proper care of animals Provide clean water and nutritionally balanced feed Follow herd health program with Veterinarian advice Provide prompt veterinary care Humane method for euthanasia Safe movement/ transportation of animals

37. USDA, Food Safety and Inspection Service Support and promote the FSIS effort to create an environment for Farm-to-Table FoodSafety Concept. Conclusion

38. USDA, Food Safety and Inspection Service References References PR/ HACCP Final Rule,(9 CFR Chapter III) July 1996. Residue Control in a HACCP Environment. Federal Register. 5(229): 70809-70815, Nov 28, 2000. Quality Assurance -A Program for Pork Producers,Level iii, National Pork Board, 1997. USDA, FSIS, Domestic Residue Data Book, National Residue Program 2000. Farm to Fork: Critical Control Points for Food Safety, J. Nutrition & Menu Development, Vol. 3(2), 2001 Milk and Dairy Beef Quality Assurance Program: Milk and Dairy Beef Residue Prevention Protocol -1996 Producer Manual Human Heal Impact and Regulatory Issues Involving Antimicrobial Resistance in Food Production Environment. Regulatory Research Perspectives. Vol. 1, Issue 1, July 2001