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APPENDIX N of the PMO Catherine Hall, LEO

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

2 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. Why were the BL’s chosen? Because these are the class that cause the greatest problems. Many people are allergic to Penicillin and other BL drugs. Severe allergic reactions can occur which can cause death. This is the most used family of drugs in lactating dairy cows. Penicillin is considered to be the strongest allergen of any drug used in veterinary medicine. Trace residues from other drugs have not been found to induce an allergic reaction which is why the beta-lactams are important from a public health standpoint.

3 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 Since I have and will continue to mention M-a’s, M-I’s, and other FDA memos, here is a description of what I am talking about. Note that these memos and a list of which ones are ACTIVE are on the FDA website.

4 Appendix N of the PMO states –
“Industry shall screen all bulk milk pickup tankers, regardless of final use, for ß-lactam drug residues.” The first sentence of Appendix N of the PMO.

5 (Milk & Dairy Products Division Memo, October 11, 1995)
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) This makes sure that all tankers are tested without relying on someone else doing it. We do make exceptions to this under special circumstances.

6 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

7 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 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. Definition of a Presumptive Positive as it stands today.

8 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 Screening lab flowchart – post it. If you would like, I can send this electronically and you can add your contacts to it to make it specific to your lab. Please do not change it other than that though. This chart comes directly from the Appendix N. Be sure that all analysts know where these forms are!! I have seen Rodney Bridge ask an analyst to show him what forms are in use. All analysts must know where the positive load forms are and how to fill them out. This form is to follow the positive sample through confirmation and producer traceback.

9 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. The next step. Once the tanker is presumptive positive – it is tested in duplicate by a certified analyst.

10 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 There are flowcharts for this portion also. The second half of the positive load form is to be filled out.

11 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. If there is more than one producer on the tanker, then each producer on board is to be tested. If a producer is positive, then it must go through confirmation.

12 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 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. Duplicates are to be done.

13 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 Many loads today have only one producer on board so producer traceback is not necessary. We see this from New Mexico loads and West Texas loads. East Texas still has multiple producers loads.

14 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. The IA is generally the person to perform the screening of the tanker. In many plants they are the receivers.

15 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) These are the responsibilities of the IA.

16 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) More IA responsibilities.

17 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 – Trained by State LEO. It is a good idea to have a backup or alternate IS. Trust me, I have seen a number of situations that could have been disastrous if a backup had not been trained.

18 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 Non-compliance is grounds for removal from list The IS has the most responsibilities. You are in charge of all of the components of Appendix N.

19 IS Responsibilities SHARE information sent by LEO with all analysts
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 One of my pet peeves has been that the IS does not share any information with the persons doing the tests. The final straw for one of the QA Managers in Texas was that this person did not share information. The program went downhill quickly and there were lots of problems. This person no longer works for that company. I know that some of the information is not pertinent to every lab, but please share what is relevant to your facility. When I write newsletters, I write it for all of you. For those of you who are not certified in all procedures – you are welcome to use the information to help your lab run a better program.

20 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 – we only technically have one in the state.

21 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 This person must be certified. Must run splits every year. Must be present for on-site every time.

22 Approved vs. Certified APPROVED CERTIFIED
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.

23 Agitation 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. A mass that has been quiescent for a period of time will require longer agitation (the time varies with product, temperature, and tank design) to completely mix the mass to give a representative sample. Also, tanks that are completely filled may require more agitation. Page 73 discusses how long tank must be agitated depending on how long the tank has been sitting since the introduction of milk to that tanker. Page 74 discusses how to determine how long to agitate a tanker by determining the milkfat composition. This would need to be done for each tanker.

24 Agitation 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! Memos regarding agitation.

25 Agitation 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. Agitation is not optional in Texas.

26 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 There is a possibility of diluting of a positive producers milk. In the case of multiple producer loads, a producer may be positive and come up positive at the plant. But when the confirmatory lab tests the load it comes up negative – it is possible that there is a producer on board that load causing a positive hit in some cases.

27 Sampling 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 I am sure that none of you would ever unload a tanker prior to the completion of any testing.

28 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 Operator ID’s must be used. Post them near the reader. The Charm II does not allow for operator ID’s unless you have a stand alone computer.

29 Record Requirements Identity of the test performed Results of the test
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 Certain information is necessary on the forms.

30 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

31 Training 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 Charm makes a nice training list which I have no problem with any of you using.

32 On-Site Survey All records must be available All analysts will be seen
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

33 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. You may not change to a new test without going through all of the above. If you do, your plant will not be allowed to test bulk milk tankers for a minimum of 15 days or until the LEO can make an on-site visit. This includes upgrading to the Charm SL6. Do not test bulk milk tankers with the SL6 without being on-sited.

34 Forms Positive Load Form Flowchart FDA 2400 Forms Revision 7/07
Appendix N – General Requirements 2/05 Charm SL / SL6 / SL3 10/07 Snap There are a number of forms that you are required to have on-site. All analysts shall be familiar with each form. The FDA 2400 forms are the checklists that are used by the LEO to perform the on-site survey. As these forms are updated by FDA, they will forwarded to your facility by the LEO as soon as I humanly can do so.

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