Drug Residue Testing: Procedures & Process

1. July 2014 Drug Residue Testing Workshops for Producer-Dealers and Small Processors Kennedy Wilson NYS Dept. of Agriculture & Markets Division of Milk Control References: Part II, MC Manual, PMO 2013, NYS Part IV and FDA’s Laboratory Proficiency Program Dairy Practices Council Guidelines Standard Methods for the Examination of Dairy Products Andrew M. Cuomo Governor Richard A. Ball Commissioner

2. Synopsis What is the actual process to start Drug Residue testing ? Terminology Is there a easy to follow procedure ? After plans are submitted and approved what does the process look like ? Beyond Planning Testing

3. How to start the Drug Testing process • You have started the process by attending and thinking about the process. • The beginning is now. • Ask questions and this is best done in writing. Verbal is never entirely accurate. • In your booklet there is a document labeled NYSDAM Application Protocol For New Laboratories in 2014. • Open it up and we’ll go through it – write your questions down – please.

4. Terminology can complicate • COC • Chain Of Custody, tracking document to affirm integrity of milk samples and related articles. • License • Is granted by NYS after demonstrating understanding and technique. • It is evidence that a basic level of training was achieved. • You’ll get a sampler and possibly a Drug Residue license. • Certified Analyst • When you complete your laboratory, training and testing you’ll be Certified for your test method under USPHS-FDA and NCIMS program to test Drug Residues.

5. Terminology can complicate • Accredited • Your Laboratory shall be recognized as Accredited under the previously mentioned program. • Note: Individual analysts are Certified for testing at an Accredited Laboratory. • LEO • Laboratory Evaluation Officer. They are standardized and certified by the FDA to perform Laboratory evaluations. • Narrative • This is a description of what you’ll test and how you would like to set up your operation. • The narrative is what you submit for approval. • We’ll review it and either suggest changes, accept it or disapprove it; in writing.

6. Terminology can complicate • Split Sample or Proficiency Sample Program • Christina will go over the basics but in general annually all certified analysts need to successfully participate in a testing program. • SOP / Protocol • Is a Standard Operating Procedure. • They are common in laboratory programs because methods are exact • Procedural Drift • When SOP’s are not followed and your laboratory work drifts naturally from recognized and approved procedures.

7. Set up for Success

8. The procedure for moving forward • It is quite simple to move forward from this stage. • Find out who your assigned LEO is and contact them. • Submit your narrative to the LEO and request they respond as soon as possible. • In your narrative have not less than: • What type of milk or milks you’ll test and who'll sample. • What method you hope to use. • Describe the location of the laboratory, or who shall test. • Include a to scale 2D drawing of your proposed lab. • Any other information you believe will help the move approval process forward. • Note Project time table is very helpful for both parties

9. Ice Box Counter / Desk 2 wall cabinets above with desk lamp Files Ceiling Light Dry Storage racks, labels, office supplies

10. Moving beyond the planning stage • After plans are submitted prepare for your samplers license exam. • Your NYS Dairy Products Specialist (DPS) will work with you on your samplers license. • Contact DPS to assure you have the proper equipment. • Practice sampling and discuss any nuances with your DPS prior to the exam. • Prepare your Quality Control (QC) records by developing your blank sampling, COC and testing reports. And importantly identifying where records will be kept.

11. Moving onto the Testing Stage • Schedule your samplers exam. • Start keeping records as soon as you can. NOTE: It is recommended to have your DPS and LEO review your record keeping early on. • Record receipt of supplies, adjustments made to equipment and daily information temperatures, practice testing, calibrations etc. • You’ll need to have at least 15 days of records on file prior to your laboratory being accredited. • This does a couple things, allows you practice and will demonstrate your record keeping meets the intent of the program. →Confirm your plans have been approved.

12. Moving onto the Testing Stage • Schedule your Drug Residue Testing exam. • For your Drug Residue exam: • Have milk samples ready. • Expect to make controls and document • Do Daily checks on equipment and document. • Test controls and document • Test a milk sample and document • Review your program with the LEO by explaining your documentation, SOP of positive milk, COC, the rejection of milk, reporting of positives etc Tip: prepare by talking while training

13. You are now a Certified Analyst with an Accredited Laboratory • Write down any comments or questions you may have. • Sample and test without delay, test Immediately, Prior to processing • Reoccurring theme is ….. ? ? ? • Please feel free to call any of us and always double check if you’re not comfortable with anything.

16. Takeaways to Emphasize TIME • Entire program is based on proper sampling • Set up for success by having a clear and easily understood plan • Dedicate space so it is simple to keep records, take samples, test sample, maintain records etc. • Good preparation saves you the only thing you can’t buy … ? • This is not difficult, it’s just a procedure.

17. Basic Flow Chart Parlor and receiver Milk Wash vat Milk Pump Filter Glycol cooler Temperature Transmitter Precooler Refrigerator with sampling device Flow and temperature transmitter

19. Takeaways

20. Nontraditional - Indirect Load • Indirect Loading of milk to a bulk truck • Basic flow: • Parlor, receiver group, optional precooler or glycol cooler, (direct expansion) cooled bulk tank. When tank is full it’s measured and sampled in a traditional way and pumped on a truck. • → Licensed samplers, Sample storage facility.

21. How to write an SOP • Start with a Basic Flow Chart to determine what areas will need to addressed. • This can be done in simple flow chart format. • High light areas you want to cover in your SOP. • 1st draft doesn’t have to be perfect, send to colleagues for proofing. Often several drafts are done. • Train farm samplers with the SOP, get their input • Set up trail runs and NYSDAM testing.

23. Summary A positive take away If you don’t know ASK If you know ASK Current program is being updated to keep pace DPS Role is to over see, assist CMI with professional support, develop relationships of compliance CMI’s Role is to coordinate installations and advocate for producer as their QC Technique be self critical, develop a method Review, timeliness is key, get help if need be