MFRPS Change ProcessMarch 13, 20148:30 – 9:15 am

Steven MandernachBureau Chief

Food and Consumer SafetyIowa Department of Inspections

and Appeals

Timothy WeignerStaff Director

U.S. FDA Office of Regulatory Affairs Office of Partnerships

Standards Implementation Staff

Kimberly StrykerProgram Manager

Food Safety and SanitationState of Alaska

Who Proposes Changes?

States

FDA

MFRPS

MFRPABoard Prep Work

Overall Standards Structure Review– Logical placement of standards– Conflicts– Definitions– Other standards systems• FDA International System recognition process• PHAB Accreditation• ISO

CommitteesIn

spec

tions

& A

udits

2 3 4 6 Ill

ness

& L

abor

ator

ies

5 10

Prog

ram

Adm

inist

ratio

n

1 7 8 9

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 VoteFDA

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 Process @ Committee Review Level

FDA representation & participation on Standard Sub-committees

FDA submits recommendations

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

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

What happens within FDA at this Step?

MFRPS Change Process w/i FDAAfter Recommendations are Received from

PFP

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)

Next Steps and Time Line

September 30th

2016

Questions

Contact Information

Timothy WeignerStaff Director

U.S. FDA Office of Regulatory Affairs Office of Partnerships

Standards Implementation StaffTimothy.weigner@fda.hhs.gov

Steven MandernachBureau Chief

Food and Consumer SafetyIowa Department of Inspections

and AppealsSteven.mandernach@dia.iowa.gov

Kimberly StrykerProgram Manager

Food Safety and SanitationState of Alaska

kimberly.stryker@alaska.gov