MFRPS Change Process

1. MFRPS Change Process March 13, 2014 8:30 – 9:15 am Kimberly Stryker Program Manager Food Safety and Sanitation State of Alaska Steven Mandernach Bureau Chief Food and Consumer Safety Iowa Department of Inspections and Appeals Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs Office of Partnerships Standards Implementation Staff

2. Who Proposes Changes?

3. MFRPABoard Prep Work Overall Standards Structure Review • Logical placement of standards • Conflicts • Definitions • Other standards systems • FDA International System recognition process • PHAB Accreditation • ISO

4. Committees

5. Committee Composition

6. Committee Charges • Evaluate elements of each standard • Achievable & measurable • Correctly placed under each standard • In conflict with other standards/elements • Identify needed changes • Consider interpretations document • Consider impacts to other standards

7. Timeline FDA MFRPA Vote Present to MFRPA Committee Work

8. Inspections and Audits Standards 2, 3, 4, and 6 • Chair: Natalie Adan (GA) AFDOSS • Co-Chair: MorganPoloni (AK) WAFDO

9. Illness and Laboratories Standards 5 and 10 • Chair: Michael Moore (MA) NEFDOA • Co-Chair: Matt Ettinger(VA) CASA

10. Program Administration Standards 1, 7, 8, and 9 • Chair: Ben Miller (MN) NCAFDO • Co-Chair: Adam Inman (KS) MCAFDO

11. Committee Members

12. FDA Involvement in the MFRPS Change Process @ Committee Review Level FDA submits recommendations FDA representation & participation on Standard Sub-committees

13. FDA Involvement in the MFRPS Change Process @ Committee Review Level • FDA Office of Partnerships participation on sub-committees, and coordinating necessary FDA stakeholder participation • Coordinating harmonization with existing programs and national standards

14. MFRPS Change Process w/i FDAAfter Recommendations are Received from PFP • FDA Office of Partnerships makes final determination on proposed recommendations (accepted and rejected) • Accepted recommendations are coordinated for review by FDA Offices/Center: • FDA Field Food Committee • CFSAN • ORA Office of Policy and Risk Management (OPRM) • Disapproved recommendations returned to the Alliance Board

15. MFRPS Change Process w/i FDAAfter Recommendations are Received from PFP What happens within FDA at this Step?

16. MFRPS Change ProcessAfter Recommendations are Received from PFP (cont.) • FDA Office of Partnerships coordinate with ORPM for submission of next MFRPS version to OMB for review and approval • Paperwork Reduction Act • Burden of Work Statement • Federal Register postings • Process may take up to a year • FDA OP publishes OMB approved document (Next Version of the MFPRS)

17. Next Steps and Time Line September 30th 2016

18. Questions

19. Contact Information Kimberly Stryker Program Manager Food Safety and Sanitation State of Alaska kimberly.stryker@alaska.gov Steven Mandernach Bureau Chief Food and Consumer Safety Iowa Department of Inspections and Appeals Steven.mandernach@dia.iowa.gov Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs Office of Partnerships Standards Implementation Staff Timothy.weigner@fda.hhs.gov