APPENDIX N of the PMO Catherine Hall, LEO Laboratory Certification Office Quality Assurance Unit Laboratory Services Section.

APPENDIX NAPPENDIX Nof the PMOof the PMO

Catherine Hall, LEOCatherine Hall, LEOLaboratory Certification OfficeLaboratory Certification Office

Quality Assurance UnitQuality Assurance UnitLaboratory Services SectionLaboratory Services Section

Appendix N – Why?Appendix N – Why? Why the ß-Lactams? They may cause hypersensitivity reactions

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 NFDA 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 NAppendix 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 NAppendix 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 NAppendix 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 DefinitionsAppendix 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 promptly repeated 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 DefinitionsAppendix 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 DefinitionsAppendix 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 DefinitionsAppendix 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 DefinitionsAppendix 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 DefinitionsAppendix 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 duplicate using 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 DefinitionsAppendix 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 DefinitionsAppendix N Definitions

Industry Analyst (IA)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 ResponsibilitiesIA 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 ResponsibilitiesIA Responsibilities

Maintain test kit control testing records Perform initial test on tankers NOT FOUNDNOT FOUND – clear milk for processing FOUNDFOUND – Run same sample in duplicate Fill out positive load form Alert appropriate persons (supervisor,

manager, Sanitarian, State Regulatory Authority)

Appendix N - DefinitionsAppendix N - Definitions

Industry Supervisor (IS)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 ResponsibilitiesIS 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 ResponsibilitiesIS 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.

SHARESHARE information sent by LEO with all analysts Newsletters, FDA memos, new forms, flowcharts, etc

Appendix N DefinitionsAppendix 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 ResponsibilitiesCIS 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. CertifiedApproved vs. Certified

APPROVED Allows for Appendix N Screening of milk from

bulk milk pickup tankers for ß-lactams (perform initial ß-lactam test and duplicates)

CERTIFIED 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.

AgitationAgitation

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.

AgitationAgitation

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!

AgitationAgitation

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 SamplesProducer 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

SamplingSampling

If the milk pickup tanker is unloaded and commingled prior to obtaining a NOT FOUND 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 RequirementsRecord 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 RequirementsRecord 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 TankerPositive 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

TrainingTraining

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 SurveyOn-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 TestsAppendix 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.

FormsForms 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