Appendix N Pilot Program


The implementation of the NCIMS Proposal 211 Pilot Program is July 1, 2017.  The Pilot Program will use the FDA evaluated and Appendix N Modification Committee accepted Charm ROSA Tetracycline-SL Test (Dilution Confirmation) and the M-a-85 FDA evaluated and NCIMS accepted Charm II Tetracycline test methods.  Other test kit methods would be brought into the Pilot Program as they are evaluated by FDA and accepted by the Appendix N Committee for the Pilot Program, and after FDA has made recommendations of test kit equivalence.  Participation would begin with users who have Charm ROSA tetracycline-SL (Dilution Confirmation) Test or the Charm II Tetracycline Test.

The following information and documents support the administration of the Pilot Program:

  1. Implementation Date for tetracycline class of drugs testing – July 1, 2017.    The Appendix N Pilot Program, including implementation date, was approved by vote of the NCIMS Executive Board concluding on April 4, 2017.
  2. Frequency of testing – No less than one (1) out of fifteen (15) bulk milk tankers including farm bulk tank milk prior to processing on the farm received per quarter.
  3. Test methods to use where certified
    M-a-85 Approved Methods for Tetracyclines
    Charm® II Tetracycline Drug Test (Competitive Assay)
    Pilot-Approved Methods for Tetracyclines
    Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)
  4. Documents
    a. 2015 NCIMS Proposal 211 Pilot Program Accepted Tetracycline Test Kit Using Both      Undiluted and Diluted Steps
    b. Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits
    c. Drug Residue Test Methods for Confirmation Tetracyclines Proposal 211 Pilot
    d. Appendix N Pilot Program Question and Answer Version 4
    e. PowerPoint 2015 NCIMS Proposal 211 Raw Milk Testing Pilot for Non-Beta Lactam        Drugs Version 4 2017
    f.  FDA evaluated and Appendix N Modification Committee accepted Charm ROSA       TETRACYCLINE-SL (Dilution Confirmation) FORM PROPOSAL 211 PILOT, “TETRACYCLINE PILOT PROGRAM, BULK MILK TANKER SCREENING TEST FORM, CHARM® ROSA TETRACYCLINE-SL TEST   DILUTION CONFIRMATION), (Raw Commingled Cow Milk)”