1. Current MFRPS State Implementation Status February 3, 2016 9:15 – 9:45 am Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs, Office of Partnerships, Standards Implementation Staff

2. Implementation Status Determination: Methodology, Scope and Limitations Who’s Involved Determining, Measuring, and Reporting Implementation Determination of State’s implementation/conformance of the MFPRS – Audit Staff

3. Additional Resources for MFRPS Progress Determination Mid-year and year-end deliverables and report reviews FDA District Offices Office of Regulatory Science (lab accreditation) Office of Operations/Audit Staff scheduled assessments and audits

4. SIS MFRPS Evaluation and Trends Analysis OP/SIS Program Element (PE) worksheets (tool) to assist evaluating State program MFRPS implementation/progress Measures: – “Yes” (meets) –“No” (gap(s) identified) –“NA” (not applicable) Metric database allows for trends analysis by: –Individual program standards –Individual program element –State progress over a period of time

5. Example of OP/SIS Program Element Worksheet (Std 3)

6. Evaluation by Program Element Evaluation by State Program Example of OP/SIS Program Element Data Analysis by Program Standard on a National Level

7. Additional Use of the Data Focus on continuous improvements Identification of gaps to redirect national resources and training Continue to refine metrics and improve ways to analyze data

8. What Does the Data Reveal? State Implementation Progress of the MFPRS (2013-2015):

9. State Implementation Progress of MFRPS Standard 1 – Regulatory Foundation (n = 40)

10. State Implementation Progress of MFRPS Standard 2 – Training Program (n = 40)

11. Challenging Program Elements: Standard 2 – Training Program Each inspector completes a minimum of ten joint inspections or audit inspections with a qualified trainer… (2.3.a) Improvement from 65% to 78% Each inspector completes a minimum of three joint inspections with a qualified trainer of food plants representing… (2.3.b) (Advanced Level) Improvement from 53% to 65% Each inspector conducting manufactured food inspections receives 36 contact hours of classroom training continuing education every 36 months… (2.3.c) Improvement from 68% to 78%

12. State Implementation Progress of MFRPS Standard 3 – Inspection Program (n = 40)

13. Challenging Program Elements: Standard 3 – Inspection Program FY14, 14 of the 20 program elements had an implementation status of < 70% FY15 improvements – Only 2 program elements had an implementation status of < 70 The state program has written policies and procedures for inspecting food plants that require inspectors to: (items listed in section 3.3.b.1-22) Improvement from 43% to 68% The State program has written procedures for identifying and maintaining records about essential recall information. (3.3.c.4 and 3.5) Improvement from 53% to 68%

14. State Implementation Progress of MFRPS Standard 4 – Audit Program (n = 40)

15. Program Elements: Standard 4 – Audit Program (FY15) Quality Assurance Program Field Inspection AuditsInspection Report AuditsSample Report Audit Corrective Action Plan Documentation Program Element 1.a1.b2.a2.b2.c3.a3.b3.c4.a4.b4.c5.a5.b6.a6.b No. of YES1614232725221918 14 18 16 No. of NO2426171315182122 26 22 24 No. of NA000000000000000 Percentage Yes 4035586863554845 35 45 40 Percentage No 6065433338455355 65 55 60 Percentage NA 000000000000000

16. State Implementation Progress of MFRPS Standard 5 – Food-Related Illness & Outbreak Response (n = 40)

17. Challenging Program Elements: Standard 5 FY14, 6 of the 20 program elements had an implementation status of < 70% FY15 improvements – Only 3 program elements had an implementation status of < 70 Coordinate traceback and trace-forward of food implicated in an illness, injury, or outbreak (5.3.d) Improvement from 58% to 60% Established criteria and written procedures for the release of investigation information … (5.3.i and 5.5) Improvement from 63% to 65% Written agreement that identifies and describe sources of supplemental laboratory capacity and expertise including laboratory support… (5.5) Improvement from 55% to 60%

18. State Implementation Progress of MFRPS Standard 6 – Compliance & Enforcement Program (n = 40)

19. Program Elements: Standard 6 – Compliance & Enforcement Program (FY15) Compliance and Enforcement Program Performance Review and Enforcement Action Program Element 1.a1.a.11.a.21.a.31.a.41.a.52.a2.a.12.a.22.a.3 No. of YES35311525282616131512 No. of NO592515121424272528 No. of NA0000000000 Percentage Yes 88783863706540333830 Percentage No 13236338303560686370 Percentage NA 0000000000

20. State Implementation Progress of MFRPS Standard 7 – Industry & Community Relations (n = 40)

21. State Implementation Progress of MFRPS Standard 8 – Program Resources (n = 40)

22. State Implementation Progress of MFRPS Standard 9 – Program Assessment (n = 40)

23. State Implementation Progress of MFRPS Standard 10 – Laboratory Support (n = 40)

24. Summary Data reflects great progress by the states Root cause analysis – changes in strategic plans Trend data is now part of state reports Continuous improvements/coordination within FDA stakeholders What’s next with the 2016 MFRPS?

25. Questions

26. Contact Information Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs, Office of Partnerships, Standards Implementation Staff Email: Timothy.weigner@fda.hhs.govTimothy.weigner@fda.hhs.gov