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APPENDIX N of the PMO. Catherine Hall, LEO Laboratory Certification Office Quality Assurance Unit Laboratory Services Section. Appendix N – Why?. Why the ß -Lactams? They may cause hypersensitivity reactions in some people

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appendix n of the pmo


Catherine Hall, LEO

Laboratory Certification Office

Quality Assurance Unit

Laboratory Services Section

appendix n why
Appendix N – Why?
  • Why the ß-Lactams?
  • They may cause hypersensitivityreactions in some people
    • Because of this, residues of ß-lactam type antibiotics are of greatest concern from the standpoint of human food safety.
  • ß-lactam antibiotics are the most commonly used & largest volume drugs administered to dairy cows.
  • Can cause resistant organisms.
  • Can cause quality problems for cultured products.
fda memos regarding app n
FDA Memos Regarding App N
  • What do these mean??
  • M-a = Memorandum of Interpretation
    • Clarification of the intent or meaning of wording related to the PMO / DMO / Methods / EML
  • M-I = Memorandum of Information
  • IMS-a = transmittal of information related to the actions taken at the NCIMS conferences and between PHS/FDA & the NCIMS Executive Board
appendix n
Appendix N
  • Appendix N of the PMO states–
    • “Industry shall screen all bulk milk pickup tankers, regardless of final use, for ß-lactam drug residues.”
appendix n5
Appendix N
  • ‘Every plant that receives a bulk milk tanker of milk shall screen that tanker for ß-lactam drug residues regardless of whether or not it was screened elsewhere.’
      • (Milk & Dairy Products Division Memo, October 11, 1995)
appendix n6
Appendix N
  • Exceptions:
    • A new plant may have its milk screened at an approved / accredited plant until the first survey
    • A plant that has lost its approval / accreditation may have its milk screened at an approved plant during the interim
appendix n definitions
Appendix N Definitions
  • Presumptive Positive
    • A presumptive positive test is a positive result from an initial testing of a tanker using M-a-85 (latest revision) approved test which has been promptlyrepeated in duplicate with performance checks, positive and negative controls using the same test kit, on the same sample, by the same analyst, with one or both of these duplicate results giving a positive result.
appendix n definitions8
Appendix N Definitions
  • Screening Lab Flowchart
    • Post this flowchart by the testing area
    • All analysts must know what to do
  • Positive Load Forms
    • Forms available to all analysts
    • Example form available
    • This form must follow the sample through confirmation & producer traceback
appendix n definitions9
Appendix N Definitions
  • Screening Test Positive Load or Load Confirmation
    • A screening test positive result is obtained when the presumptive positive sample is tested in duplicate, using the same or equivalent tests (M-I-96-10, latest revision) as that used for the presumptive positive, with performance checks, positive & negative controls, and either or both of the duplicates are positive and the controls give proper results.
appendix n definitions10
Appendix N Definitions
  • Screening Test Positive (cont.)
    • A screening test positive (load confirmation) is to be performed by an Official State Laboratory or an Officially Designated Laboratory using the same or equivalent test (M-I-96-10, latest revision)
    • Flowcharts
    • Positive Load Forms
appendix n definitions11
Appendix N Definitions
  • Producer Traceback / Permit Action
    • A producer traceback / permit action test is performed after a screening test positive load is identified by an Official State Laboratory or an Officially Designated Laboratory using the same or an equivalent (M-I-96-10, latest revision) test as was used to obtain the screening test positive (load confirmation). A confirmed producer test positive result is obtained in the same manner as a confirmation (screening test positive) for a load.
appendix n definitions12
Appendix N Definitions
  • Producer Traceback / Permit Action
    • After an initial positive result (producer presumptive positive) is obtained on a producer sample, that sample is then tested in duplicateusing the same test as was used to obtain the producer presumptive positive result. This testing is performed with performance checks, positive & negative controls and if either or both of the duplicates are positive and the controls give the proper results, the producer sample is confirmed as positive.
appendix n definitions13
Appendix N Definitions
  • Individual Producer Load
    • An individual producer bulk milk pickup tanker is a tanker (or compartment of a tanker) that contains milk from only one dairy farm
appendix n definitions14
Appendix N Definitions
  • Industry Analyst (IA)
    • A person under the supervision of the Industry Supervisor (IS) who is assigned to conduct screening of bulk milk pickup tankers for Appendix N drug residue requirements.
    • These are the individuals who perform the bulk of the tanker testing.
ia responsibilities
IA Responsibilities
  • Receive training from the IS
  • Remain current on all testing procedures
  • Run split samples every year
  • Demonstrate testing competence to LEO or IS at least every other year (or when there is an on-site survey)
ia responsibilities16
IA Responsibilities
  • Maintain test kit control testing records
  • Perform initial test on tankers
  • NOT FOUND – clear milk for processing
  • FOUND – Run same sample in duplicate
  • Fill out positive load form
  • Alert appropriate persons (supervisor, manager, Sanitarian, State Regulatory Authority)
appendix n definitions17
Appendix N - Definitions
  • Industry Supervisor (IS)
    • An individual trained by the State Laboratory Evaluation Officer (LEO) who is responsible for the supervision and training of Industry Analysts (IA) who test bulk milk pickup tankers for Appendix N drug residue requirements.
    • Also refers to Alternate IS or Backup IS
    • Every plant MUST have an IS
      • Or the plant may not receive raw bulk milk tankers
is responsibilities
IS Responsibilities
  • Receive training from State LEO
  • Remain current on all testing procedures being performed
  • All responsibilities of IA
  • Provide training to IA
  • Keep list of IA current
  • Report changes of IA to LEO within 30 days of change – may be done via e-mail
    • Non-compliance is grounds for removal from list
is responsibilities19
IS Responsibilities
  • Train all analysts initially & annually thereafter
  • Split samples every year
  • On-site every other year
  • Maintain training records
    • Send the dates of training to LEO when sending updated list.
  • SHARE information sent by LEO with all analysts
    • Newsletters, FDA memos, new forms, flowcharts, etc
appendix n definitions20
Appendix N Definitions
  • Certified Industry Supervisors
    • Analysts who are evaluated by the State LEO to perform drug residue testing and other milk tests. These analysts are allowed to confirm presumptive positive drug residue tests, perform producer traceback & producer permit actions.
    • These individuals are listed in the IMS List
cis responsibilities
CIS Responsibilities
  • All the same as the Industry Supervisor
  • Run split samples every year
  • Must be present for on-site evaluation every two years to maintain certification
  • The difference is that the CIS runs confirmations
approved vs certified
Approved vs. Certified
    • Allows for Appendix N Screening of milk from bulk milk pickup tankers for ß-lactams (perform initial ß-lactam test and duplicates)
    • For the purposes of Appendix N: Allows for the screening of milk from bulk milk pickup tankers for drug residues AND for the confirmation of drug residues in the milk from bulk milk pickup tankers and producers.
  • From SMEDP, 17th Ed. page 73
    • With inadequate agitation of bulk tank milk (trucks / tankers / plant storage tanks) samples taken from the top of the tank contain more bacteria, somatic cells, and milkfat than samples taken low in the tank. Higher numbers of cells are caused by the rising of fat globules, which “sweep” microbes and somatic cells toward the surface, thus concentrating them in the cream layer.
  • M-a-82 – December 28, 1993
  • States that agitation should be minimum of 15 minutes
  • June 28, 2000 TDH Memo
  • States to agitate for a minimum of 15 minutes
  • October 9, 2006 Milk Information Release
  • Proper Agitation of Bulk Milk Tankers
  • This is not an option in Texas!
  • If a tanker test comes up positive and you know for sure that the tanker was not agitated properly, long enough or not at all – you still must notify the State Regulatory Agency before proceeding.
  • Only with the permission of TDSHS may you re-sample the tanker.
producer samples
Producer Samples
  • Producer samples shall travel with the bulk milk pickup tanker
  • If a tanker is positive – the producer samples must accompany the positive sample to the official laboratory for producer traceback
  • Whether the load is positive or negative upon confirmation – there must be producer traceback
  • If the milk pickup tanker is unloaded and commingled prior to obtaining a NOTFOUND test result and the screening test is POSITIVE, the State Regulatory Agency must be notified immediately
  • At this point your silo is contaminated and must be dumped
record requirements
Record Requirements
  • Who is doing the test?
    • Use Operator ID’s on Charm SL & Snap
  • Identity of the bulk milk tanker being tested
    • Include the BTU number(s) of the farms present on the tanker being tested
  • Date / Time the test was performed (Time / Day / Month / Year)
    • Be sure that the reader has the correct time
record requirements29
Record Requirements
  • Identity of the test performed
    • Kit Lot #
    • Controls – Lot # / result values
    • Performance Checks – ranges
  • Results of the test
    • Positive or NF (Not Found) and the value from the reader
  • Follow-up testing if initial test was positive including all new controls
positive tanker
Positive Tanker
  • Once a tanker is determined “presumptive positive” –
    • Notify TDSHS
    • Make a copy of the Positive Load Form
    • Give the copy to the Sanitarian or you may be asked to fax it to the confirmation lab
    • This form should end up at TDSHS with all information filled out
  • Use the FDA 2400 Checklist
  • Watch the analyst(s) run the test
  • Explain what Appendix N is and why we test every tanker
  • Explain why it is critical to agitate the tanker
on site survey
On-Site Survey
  • All records must be available
    • Thermometers, pipettors, balance, weights, new lot records, daily temperatures, daily testing forms with printouts
  • All analysts will be seen
  • LEO will work with supervisor / manager on scheduling to see every analyst
appendix n tests
Appendix N Tests
  • What do you do if you want to change from one test to another?
    • Notify the LEO.
    • Comparisons – new vs. old.
    • On-site scheduled.
    • You may not run the new test until the LEO has given approval.
  • Positive Load Form
    • Revision 7/07
  • Flowchart
    • Revision 6/06
  • FDA 2400 Forms
    • Appendix N – General Requirements
      • 2/05
    • Charm SL / SL6 / SL3
      • 10/07
    • Snap
      • 10/07