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Appendix “N” Modification Study Committee, (Proposal 05-243 Appendix “N” Modification Study Committee, (Proposal 05-243

Appendix “N” Modification Study Committee, (Proposal 05-243 - PowerPoint Presentation

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Appendix “N” Modification Study Committee, (Proposal 05-243 - PPT Presentation

2015 NCIMS Proposal 211 Raw Milk Testing Pilot for NonBeta Lactam Drugs 2017 NCIMS Presentation on 211 Update Appendix N Modification Committee 14 members 7 State Regulatory 6 Industry and 1 Academia VOTING MEMBERS ID: 756941

pilot committee appendix milk committee pilot milk appendix ncims modification proposal program tetracycline test actions testing drugs 2017 methods

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Slide1

Appendix “N” Modification Study Committee, (Proposal 05-243)

2015 NCIMS Proposal 211Raw Milk Testing Pilot for Non-Beta Lactam Drugs2017 NCIMS Presentation on 211 UpdateSlide2

Appendix N Modification Committee

(14 members, 7 State Regulatory, 6 Industry, and 1 Academia – VOTING MEMBERS)Roger Hooi

Dean Foods/Chair

Roger Tedrick

Ohio/Vice Chair

Tom Angstadt

DFA

Frank Barcellos

Oregon

Beth Briczinski

NMPF

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

(Retired)

Tennessee

Laurie Bucher (Retired)

MarylandSlide3

Appendix N Modification CommitteeFDA Advisors

Dennis Gaalswyk

CFSAN

Amber McCoig

CVM

Phil Kijak

CVM

Tom Graham

LPET

Tim Roddy

ORA

Jeff Hamer

CFSAN

Christina Megalis

LPETSlide4

Charm SciencesDSM Food SpecialtiesIDEXX Labs

NeogenAppendix N Modification CommitteeSuppliersSlide5

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-lactamsNo Packaged/Finished product testingAmphenicols

(

florfenicol

), NSAIDs (

flunixin

), Sulfonamides, Macrolides,

Tetracyclines

, Aminoglycosides, and AvermectinsSampling and test method(s)Reporting

Appendix N - Proposal 211

Committee AssignmentSlide6

1. Establishing a regulatory framework – pilot

Three main thingsSlide7

Testing

raw milk for veterinary drugs 2. Test Methods and proceduresSlide8

3. Drugs other than Beta-lactamsSlide9

Committee Actions

Conference Calls and meetings>24 Conference Committee Calls from 2015Numerous subcommittee calls on Q&A2 Physical meetings

July 2015 – Targeted

drug

identified, initial Framework, funding request, Q&A Subcommittee, developed initial roadmap

July 2016 – Committee meeting in Kentucky, test methods, timeframe, LPET LEO responsibilitiesSlide10

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 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.

Committee Actions

The pilot is for Grade “A” COW raw milk onlySlide11

2015 NCIMS Proposal 211 Pilot Program Funding for States and small producer-processor

Laurie Bucher – MarylandSurveyed StatesFDA Office of Partnership funding was not achieved for the pilotSmall producer-processors experiencing difficulty implementing the Pilot Program should discuss concerns with their State Regulatory Agency.

Committee Actions

FundingSlide12

Committee Actions

Questions and Answers DocumentQ&A SubcommitteeSteve DiVincenzo, IllinoisFDA CFSANVersion 4.0

~33 different questionsSlide13

SuppliersCVM protocols and directions

CVM reviewed method(s)Charm SL TetIDEXX

NEOGEN

Methods and Procedures

Supplies, CVMSlide14

LEO ResponsibilitiesReview of methods submission2400 forms development

Committee ActionsLPET, CVM, Lab CommitteeSlide15

NCIMS Board informedDeveloped Power Point on the Pilot

Presentations2015Regional Milk Seminars: early version of update was provided at two RMS in 2015Annual MD Dairy Industry/Health Department

Meeting

2016

Pacific Southwest

RMS

Central States

RMS

IDFA – Cultured Products

MeetingAssociated Illinois Milk, Food and Environmental SanitariansAnnual MD Dairy Industry/Health Department

Meeting

NADRO

IAFP

Kentucky Dairy Meeting

NY State association for Food Protection Meeting

Dairy Practices DPC

Committee Actions

CommunicationsSlide16

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.

Committee ActionsMarch 2017Slide17

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

Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits (Certification)Drug Residue Test Methods for Confirmation Tetracyclines Proposal 211 Pilot (Equivalency)

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

NCIMS Board on Implementation Date

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)”

Committee

Actions

Available

Documents at http://ncims.org/Slide18

Q&A version 5National Milk Drug Residue Database

Frequency of report for tetracycline family of drugsQC of dataCompilation and reviewUpdate of new methods for pilotEducating, communicating on pilot

Committee

Actions

Continued WorkSlide19

2017 NCIMSAppendix N Modification Study CommitteeSlide20

2017 NCIMS Appendix N Modification Study Committee

14 proposals 8 passed, 1 tabled, 5 No actions1 Tabled (proposal 217) requiring further work on a more complete

proposal to move Unapproved Voluntary Testing Program to a separate appendix

1 Passed as submitted

7 Passed Amended

5 No actionsSlide21

Proposals related to the pilot such as (BetaStar® Advanced for

Tetracyclines, Reporting to 3rd Party Database)Clarifying language2017 NCIMS Appendix N Modification Study CommitteeSlide22

Other communication – “Unapproved tests” (2015 NCIMS Proposal 213)2017 NCIMS Conference Actions

Committee ActionsOther workSlide23

2017 NCIMSQuestionsSlide24

DatabaseSome ChartsSlide25
Slide26
Slide27
Slide28
Slide29
Slide30
Slide31

So what?Lots of testing done!Appendix N