Version 4 March 20, 2017 Updatencims.org/wp-content/uploads/2017/04/PowerPoint-2015... · 2017-04-06 · 2015 NCIMS Proposal 211. Raw Milk Testing Pilot for Non-Beta Lactam Drugs

2015 NCIMS Proposal 211Raw Milk Testing Pilot for Non-Beta Lactam Drugs

Version 4 March 20, 2017 Update

Roger Hooi Dean Foods/Chair

Roger Tedrick Ohio/Vice Chair

Tom Angstadt DFA

Frank Barcellos Oregon

Beth Briczinski NMPF

Laurie Bucher Maryland

Steve Divincenzo Illinois

Don Falls Missouri

Pat Gorden Iowa State

Bob Hagberg LOL

Harris Hollingsworth Texas

Rebecca Piston HP Hood

Lewis Ramsey Kentucky

John Sanford Dean Foods

Bill Thompson (Ret) Tennessee

Dennis Gaalswyk CFSAN

Amber McCoig CVM

Phil Kijak CVM

Tom Graham LPET

Tim Roddy ORA

Jeff Hamer CFSAN

Christina Megalis LPET

Charm Sciences DSM Food Specialties IDEXX Labs Neogen

Busy! Since 2007 >85 conference calls. 2013-2017 current >70 conference calls

(not including subcommittee calls) 1-2 hour Conference calls 5 “Physical” Meetings (1 – 2013, 2- 2014, 1-2015, 1-2016 July

25th – 27th)

Review of Proposal 211

The Appendix N Modification Committee is charged to develop a pilot program, establishing a regulatory framework by which testing raw milk for veterinary drugs would be required for drugs other than beta-lactams

No Packaged/Finished product testing The pilot program, when finalized, would include, but is not

limited to, consideration of the following criteria (8 deliverables)

Veterinary drugs required to be tested◦ FDA’s recommendation from the output of the risk ranking

model: Beta lactams, Amphenicols (florfenicol), NSAIDs (flunixin), Sulfonamides, Macrolides, Tetracyclines, Aminoglycosides, and Avermectins

Testing methodology Availability of suitable test methods Number of samples to be collected and assayed Reduction of required Beta-Lactam testing National Milk Drug Residue Database Report of challenges of program implementation A complete report of the pilot program in 2017

Presenter

Presentation Notes

Veterinary Drugs to be tested resulted from the FDA recommendations from Multicriteria-based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products report in April 2015 Testing methodology has to be provided for the target drug Available suitable test methods for regulatory and for data is needed that has received some level of acceptance or approval Reduction of Beta-lactams was discussed but for the pilot the committee decided that this was not feasible at this time and may require changes to the PMO Appendix N program for beta-lactams How results are reported to the drug Residue Database has to be resolved The committee faces numerous challenges to be captured in Q&A and also as the pilot progress and comments are received from different States. A report is expected from the committee at the 2017 NCIMS

Committee Actions

March -October 2016 – Drug tests for targeted drug identified July 2016 – Committee meeting in Kentucky August 2016 – Committee Documents and Report to NCIMS

Board October 2016 - January 2017 – ramp up, Tetracycline Pilot

Program Forms, Lab certification, and communications July 1, 2017 – Implementation Date for Tetracycline Pilot

Programs. The Pilot Program will continue testing for the tetracycline

class of drugs until a minimum of 18 months of data are generated by each Regulatory Agency for the Appendix N Modification Committee to review testing results and make recommendations.

NCIMS Board direction relative to participation◦ At the October 7-8, 2015 NCIMS Executive Board meeting,

the Chair expressed the following in a consensus statement: “… we as a Board should look at participation by member States of the conference, as well as Grade “A” milk facilities, to be expected.” (IMS Listed Grade “A” milk plants)◦ Member States include all 50 States and Puerto Rico◦ Likewise, it’s expected that those milk facilities in the

International Certification Program (ICP)

Reference: Most current, “Appendix N Pilot Program Question and Answer”

Presenter

Presentation Notes

What about Transfer stations and receiving stations? See Q&A 1.2 Participation by transfer stations and receiving stations (as defined in the PMO) is not expected at this time for purposes of the Pilot Program. However, if a transfer or receiving station is screening milk for tetracycline class of drugs (oxytetracycline, tetracycline and chlortetracycline) instead of that load being screened at the milk plant, the milk plant is responsible for maintaining the documentation to show that the load of milk received at that milk plant has been screened for the tetracycline class of drugs and to ensure the required testing frequency of one out of every 15 loads is met.

Should any state or US territory have difficulties in implementing the program such hurdles should be brought to the attention of the Board for consideration

◦ Tetracycline class of drugs (oxytetracycline, tetracycline, chlortetracycline)◦ Tetracyclines (as a class of drugs) are proposed as the first

drug to pilot for implementation of expanded testing through the pilot program, largely based on the fact that a tolerance has been established (300 ppb), usage, and rapid test methods can be developed and approved in a timely manner

The pilot is for Grade “A” COW raw milk only The Pilot Program requires no less than 1 out of 15 (~6.7%) bulk milk

pickup tankers and/or all raw milk supplies that have not been transported in bulk milk pickup tankers of Grade “A” raw milk to be tested for tetracyclines calculated on a quarterly basis.

However, this would not prohibit industry voluntarily testing at a greater frequency

For example: 1500 Bulk Milk Pickup Tankers were received in a quarter. 1500 x 1/15 = 100 Bulk Milk Pickup Tankers to be tested in a quarter.

Testing could be accomplished all in a week, over a month, or any other means to meet the requirements by the facility in consultation with the Regulatory Agency.

Duration:◦ Implementation date of July 1, 2017 with a minimum of 18 months

duration

Who:◦ IMS listed Grade A Milk plants will be screening and reporting tetracycline

results to the Regulatory Agency (refer to Q&A latest release)

Test Methods:◦ FDA evaluated and NCIMS Appendix N Modification Committee accepted or

previously NCIMS approved/accepted (M-a-85, latest revision) test methods for screening, confirmation, producer trace back and reinstatement. Currently, the two tetracycline drug test methods that will be used as part of the Pilot Program are: Charm® II Tetracycline Drug Test (Competitive Assay) and Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)

Test kits are considered “equivalent” (see 2015 NCIMS Proposal 211 Pilot Program Accepted Tetracycline Test Kit Using Both Undiluted and Diluted Steps Flow Chart) for the purpose of confirmation, producer trace back, and producer reinstatement in the 211 Pilot Program

Presumptive Positive Test Screening Test Positive (Confirmation Test) OptionsCharm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)

Charm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)

Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)

Charm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)

Tetracycline Pilot Program Forms

“Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits”

Will not require LEO to revisit or recertify labs that will be using the same equipment for beta-lactams for tetracyclinestesting (FDA Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits)

Industry Reporting:◦ Industry will be reporting completed test results to the

Regulatory Agency (monthly) State Reporting:◦ Reported to the National Milk Drug Residue

Database (monthly)

2015 NCIMS Proposal 211 Pilot Program Funding for small producer-processor◦ FDA Office of Partnership funding was not achieved◦ Small producer-processors experiencing difficulty

implementing the Pilot Program should discuss concerns with their State Regulatory Agency.

“Drug Residue Test Methods for Confirmation of Presumptive Positive Results and Initial Producer Trace Back for the 2015 NCIMS Proposal 211 Pilot Program for Tetracycline Testing”

Initial testing on undiluted sample Initial positive repeated 2X with Positive and Negative Controls but

with diluted samples (diluent either from supplier or previously tested negative tested sample depending on test method used) to bring the test method closer to the testing limit (old Tolerance levels). Any Positive = Positive (Inform State)

Confirmation will be performed at a certified lab 2X with Positive and Negative Controls with diluted samples. Any positive = Positive

Producer trace back, each producer, on diluted sample, 1st test negative = negative, 1st test positive = Repeat 2x with controls. Any positive = Positive

Producer Reinstatement on same test as the first test, or with Charm II accepted test on diluted sample.

Presumptive Positive Test Screening Test Positive (Confirmation Test) OptionsCharm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)

Charm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)

Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)

Charm® II Tetracycline Drug Test (Competitive Assay) (M-a-85)Charm® ROSA Tetracycline-SL Test (Dilution Confirmation)

2015 NCIMS Proposal 211Pilot Program Accepted Tetracycline Test Kit Using Both

Undiluted and Diluted Steps

◦ 2015 NCIMS Proposal 211 Pilot Program Accepted Tetracycline Test Kit Using Both Undiluted and Diluted Steps

◦ Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits◦ Drug Residue Test Methods for Confirmation Tetracyclines Proposal 211 Pilot◦ Q&A Document: Appendix N Pilot Program Question and Answer Version 4.0◦ PowerPoint 2015 NCIMS Proposal 211 Raw Milk Testing Pilot for Non-Beta

Lactam Drugs Version 4 2017◦ FDA evaluated and Appendix N Modification Committee accepted Charm ROSA

Tetracycline-SL Test (Dilution Confirmation) form, “TETRACYCLINE PILOT PROGRAM, BULK MILK TANKER SCREENING TEST FORM, CHARM® ROSA TETRACYCLINE-SL TEST DILUTION CONFIRMATION), (Raw Commingled Cow Milk)”

◦ 2015 Regional Milk Seminars: early version of update was provided at two RMS in

2015 (John Sanford) Annual MD Dairy Industry/Health Department Meeting (Laurie Bucher)

◦ 2016 Pacific Southwest RMS (Roger Hooi) Central States RMS (Roger Hooi) IDFA – Cultured Products Meeting (Roger Tedrick) Associated Illinois Milk, Food and Environmental Sanitarians (Steve

DiVincenzo) Annual MD Dairy Industry/Health Department Meeting (Laurie Bucher) NADRO (Roger Tedrick) IAFP (Roger Hooi) Kentucky Dairy Meeting (Roger Hooi) NY State association for Food Protection Meeting (Roger Hooi) Dairy Practices DPC (Roger Hooi)

Presenter

Presentation Notes

Iceberg illustrations Has inherent beauty Show the tip and larger discussions to follow below that needs o be resolved. c) The next slide is a closer depiction of where we are on this iceberg. The concerns are numerous from the beginning and we have just scratched the surface. What is below is yet to be encountered through the pilot.