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
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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 ChartsSlide25Slide26Slide27Slide28Slide29Slide30Slide31
So what?Lots of testing done!Appendix N