MFRPS Change Process March 13, :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

Who Proposes Changes? StatesFDA MFRPS

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

Committees Inspections & Audits Illness & Laboratories 5 10 Program Administration

Committee Composition Recommended Changes Labs, IFPTI StatesFDA

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

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

Inspections and Audits Standards 2, 3, 4, and 6 Chair: Natalie Adan (GA) AFDOSS Co-Chair: Morgan Poloni (AK) WAFDO

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

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

Committee Members

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

FDA Involvement in the MFRPS Change 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

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

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

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)

Next Steps and Time Line September 30 th 2016

Questions

Contact Information Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs Office of Partnerships Standards Implementation Staff Steven Mandernach Bureau Chief Food and Consumer Safety Iowa Department of Inspections and Appeals Kimberly Stryker Program Manager Food Safety and Sanitation State of Alaska