Introduction to Drug Residue Testing

1. Introduction to Drug Residue Testing

2. Introduction to Drug Residue Testing • Introduction • Basic Lab Set Up • Sampling • Testing Demonstrations • Record Keeping • Proficiency Testing (Split Sample) Program • Wrap Up and Q &As

3. 2011 PMO Appendix N • Industry shall screen all bulk milk pickup tankers, regardless of final use, for Beta lactam drug residues. • The bulk milk pickup tanker shall be sampled after the last producer has been picked up and before any additional commingling. These bulk milk pickup tanker samples may be collected from an approved aseptic sampler. The sample must be representative. Bulk milk pickup tanker testing shall be completed prior to processing the milk.

4. 1 NYCRR Part 2 • A PPS shall: (iii) ensure that no commingled milk is received that exceeds the drug standard set forth in section 2.8 of this Part; • General Permit holders shall: (4) Receive no commingled milk that exceeds the drug standard, as provided in section 2.7(b)(1) of this Part and shall, when commingled milk exceeds the drug standard….

5. 2013 PMOAppendix N • Industry shall screen all bulk milk pickup tankers and/or all raw milk supplies that have not been transported in bulk milk pickup tankers, regardless of final use, for Beta lactam drug residues. • All raw milk supplies that have not been transported in bulk milk pickup tankers shall be sampled prior to processing the milk. The sample(s) shall be representative of each farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. Testing of all raw milk supplies that have not been transported in bulk milk pickup tankers shall be completed prior to processing the milk.

6. Introduction to Drug Residue Testing

7. National Conference On Interstate Milk Shipments • Conferences held every 2 years. Regulatory agencies, industry, and academia represented. • Proposals are reviewed and voted on by committees, councils, and state delegates. If passed, FDA either concurs or not. • Changes to affected documents (PMO, EML, etc.) then become enforceable 1 year after publication. • Documents regulate all aspects of Grade A milk and milk product production, processing, shipping, and testing. States are required to enforce in order to remain in the program.

8. NCIMS Program • Documents which address milk testing include: • The Pasteurized Milk Ordinance – Appendix N • The NCIMS/FDA 2400 Forms • The NCIMS/FDA Evaluating Milk Laboratories • 1 NYCRR Parts 2 and 6 • Standard Methods for the Examination of Dairy Products (17th ed.)

9. Milk Laboratory Accreditation • On-Site Evaluation • Analyst is trained/licensed • Facility and equipment is appropriate • Accurate records are maintained in an organized manner • Samples are taken by licensed milk receivers/samplers • Proficiency Testing Program • Analysts must participate in annual testing (May in NY) Demonstrates competency by testing unknown samples and accurately reporting results

10. Introduction to Drug Residue Testing

11. Introduction to Drug Residue Testing • Use appropriate test method – from FDA M-a-85 (rev 14) • Consult the test kit manufacturer for training or problems/questions • Communicate with your assigned Laboratory Evaluation Officer • Follow-up appropriately on any positive test results • Keep good records (2 years)