1. MFRPS Change Process March 13, 2014 8:30 – 9:15 am 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 Kimberly Stryker Program Manager Food Safety and Sanitation State of Alaska

2. Who Proposes Changes? StatesFDA MFRPS

3. MFRPA Board 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 Inspections & Audits 2 3 4 6 Illness & Laboratories 5 10 Program Administration 1 7 8 9

5. Committee Composition Recommended Changes Labs, IFPTI StatesFDA

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 Jul 2014 Jan 2015 Feb 2015 Mar 2015 Apr 2015 Committee Work Present to MFRPA MFRPA Vote FDA

8. Inspections and Audits Standards 2, 3, 4, and 6 Chair: Natalie Adan (GA) AFDOSS Co-Chair: Morgan Poloni (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 representation & participation on Standard Sub-committees FDA submits recommendations

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

16. MFRPS Change Process After 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 30 th 2016

18. Questions

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