1. Appendix “N” Modification Study Committee, (Proposal 05-243)
2015 NCIMS Proposal 211
Raw Milk Testing Pilot for Non-Beta Lactam Drugs
2017 NCIMS Presentation on 211 Update

2. 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)
Maryland

3. Appendix N Modification Committee FDA Advisors
Dennis Gaalswyk
CFSAN
Amber McCoig
CVM
Phil Kijak
Tom Graham
LPET
Tim Roddy
ORA
Jeff Hamer
Christina Megalis

4. Appendix N Modification Committee Suppliers
Charm Sciences
DSM Food Specialties
IDEXX Labs
Neogen

5. Appendix N - Proposal 211 Committee Assignment
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
Amphenicols (florfenicol), NSAIDs (flunixin), Sulfonamides, Macrolides, Tetracyclines, Aminoglycosides, and Avermectins
Sampling and test method(s)
Reporting

6. Three main things
1. Establishing a regulatory framework – pilot

7. Testing raw milk for veterinary drugs 2. Test Methods and procedures

8. 3. Drugs other than Beta-lactams

9. Committee Actions Conference Calls and meetings
>24 Conference Committee Calls from 2015
Numerous subcommittee calls on Q&A
2 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 responsibilities

10. Committee Actions The pilot is for Grade “A” COW raw milk only
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.

11. Committee Actions Funding
2015 NCIMS Proposal 211 Pilot Program Funding for States and small producer-processor
Laurie Bucher – Maryland
Surveyed States
FDA Office of Partnership funding was not achieved for the pilot
Small producer-processors experiencing difficulty implementing the Pilot Program should discuss concerns with their State Regulatory Agency.

12. Committee Actions Questions and Answers Document
Q&A Subcommittee
Steve DiVincenzo, Illinois
FDA CFSAN
Version 4.0
~33 different questions

13. Methods and Procedures Supplies, CVM
Suppliers
CVM protocols and directions
CVM reviewed method(s)
Charm SL Tet
IDEXX
NEOGEN

14. Committee Actions LPET, CVM, Lab Committee
LEO Responsibilities
Review of methods submission
2400 forms development

15. Committee Actions Communications
NCIMS Board informed
Developed Power Point on the Pilot
Presentations
2015
Regional Milk Seminars: early version of update was provided at two RMS in 2015
Annual MD Dairy Industry/Health Department Meeting
2016
Pacific Southwest RMS
Central States RMS
IDFA – Cultured Products Meeting
Associated Illinois Milk, Food and Environmental Sanitarians
NADRO
IAFP
Kentucky Dairy Meeting
NY State association for Food Protection Meeting
Dairy Practices DPC

16. Committee Actions March 2017
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.

17. Committee Actions Available Documents at http://ncims.org/
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
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)”

18. Committee Actions Continued Work
Q&A version 5
National Milk Drug Residue Database
Frequency of report for tetracycline family of drugs
QC of data
Compilation and review
Update of new methods for pilot
Educating, communicating on pilot

19. Appendix N Modification Study Committee
2017 NCIMS
Appendix N Modification Study Committee

20. 2017 NCIMS Appendix N Modification Study Committee
14 proposals
8 passed, 1 tabled, 5 No actions
1 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 actions

21. 2017 NCIMS Appendix N Modification Study Committee
Proposals related to the pilot such as (BetaStar® Advanced for Tetracyclines, Reporting to 3rd Party Database)
Clarifying language

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

23. 2017 NCIMS Questions

24. Database
Some Charts

31. Appendix N
So what?
Lots of testing done!