Dr. Steve Larsen - Antibiotic Residues: Methodology, Withdrawal Time and Incidences

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Antibiotic Residues: Methodology, Withdrawal Time and Incidences - Dr. Steve Larsen, Director, Pork Safety at National Pork Board, from the 2014 Minnesota Pork Congress, January 14-15, Minneapolis, MN, USA.

More presentations at http://www.swinecast.com/2014-minnesota-pork-congress

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Dr. Steve Larsen - Antibiotic Residues: Methodology, Withdrawal Time and Incidences

  1. 1. Antibiotic Residue Methodology, Withdrawal Times and Incidences. Dr. Steve Larsen Director, Pork Safety January 14, 2014
  2. 2. Outline • • • • • • FSIS Testing Cull Sow Penicillin Research National Residue Program Changes Incidences Fact Sheets Questions
  3. 3. FSIS Testing
  4. 4. From the Beginning • FSIS Changed Screening Test – 2011 for 2012 – FAST to KIS • Changed – Confirmed by HPLC MS/MS • Increased KIS and Violative Positives – Penicillin for Sows – Penicillin = Zero Tolerance – Chasing Zero • Need Withdrawal Research – Penicillin/Sows
  5. 5. Cull Sow Penicillin Research
  6. 6. The Questions • Labeled Use – 1cc/100 lbs. – 7 day withdrawal period – 10cc per Injection Site • Typical Use – – – – Extra-Label 5cc/100 lbs. Extended Withdrawal – 14 days 20cc per Injection Site
  7. 7. Research Study • Protocol – Injection Site Volume • 10cc vs. 20cc – Injection Site Location • Single vs. Multiple – Withdrawal Days • 7 to 40 • Screen with KIS • Verify with HPLC MS/MS
  8. 8. Preliminary Information • Limit of 10 mls of an injectable antimicrobial product in one site • Separate injection sites by at least 3 inches when multiple injections must be given to deliver the appropriate dose • Separate injection sites by at least 3 inches from the previous day’s injection site when multiple-day therapy is needed
  9. 9. Bottom Line…. • Penicillin Research – ARS – Extra-Label Dosage – 51 day withdrawal – kidneys – For Zero Tolerance
  10. 10. Change Is In The Air at FSIS – 2012
  11. 11. Comparison: Old vs. New • OLD METHOD • Scheduled sampling (exposure assessment) • Inspector-generated sampling • Import sampling • 300 Samples/Class • NEW METHOD • Tier 1 (exposure assessment) • Tier 2 Inspectorgenerated sampling • Tier 3 (targeted herd/flock testing) • Import sampling • 1 Sample/Multiple Tests
  12. 12. National Residue Program Important Differences •Inspector Generated Tests – Sows – KIS •Multi-Residue Method – MRM – Antibiotics, Sulfonamindes, Anti-inflammatories, βagonists, and Steroids
  13. 13. FSIS Methodology – Penicillin Sow Example • Screen Kidney with KIS • Positive Kidney Test – Generic Positive, could be anything • Send Kidney, Muscle and Liver to FSIS Lab – Carcass and Tissues Are Held Until Results – Run Multi-Residue Methodology Plate, Kidney First • 52 Analytes • Positive for Penicillin, run Muscle – Confirm with HPLC MS/MS • Zero Tolerance, so any amount is violative
  14. 14. Methodology • If: – Kidney and Muscle are violative, all get tanked – Kidney violative and Muscle non-violative, Kidneys tanked and carcass can pass – Kidney and Muscle are non-violative, all are okay • Process from screening test to confirmation? – About 4 to 5 days • Issue for pre-rigor sow plants/sausage makers • Traceability issues, Consolidators
  15. 15. Next Steps - Working with NPPC and AASV • Establish a tolerance in edible tissue – FDA – Other Commodities have 50 ppm – Reduce withdrawal to 47 days • Establish a Higher Tolerance than 50 ppm – FDA – Highly unlikely due to: • Cost • Daily Intake – allergenicity issues • Declare Sow Kidneys as inedible tissue – FSIS/Packer – Would help violations – Muscle withdrawal at 12 days
  16. 16. Now What? • 51 or 47 Day Withdrawal is Not Practical – Alternatives Are More Expensive and Closer to Human Antimicrobials • Alternatives – PolyFlex – Ampicillin • Ampicillin – Established MRL – Extra-Label usage – Approve in Canada but not U.S. – Research to Find Withdrawal Time
  17. 17. Incidences of Residues
  18. 18. What Animals Are Tested? • • • • Boars/Stags Market Hogs Roaster Pigs Sows • Let’s focus on the New Method!
  19. 19. April – June 2013 • Boars/Stags – None • Market Hogs – 3 Penicillin – 1 Sulfamethazine • Roaster Pigs – None • Sows – 45 Penicillin – 3 Sulfamethazine – 1 Gentamycin Sulfate
  20. 20. July – September 2013 • Boars/Stags – None • Market Hogs – 1 Penicillin • Roaster Pigs – None • Sows – – – – 19 Penicillin 2 Zearalanol 1 Ampicillin 1 Desfuroylceftiofur
  21. 21. Information Sheets
  22. 22. Questions?

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