MFRPS Change Process
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Transcript of MFRPS Change Process
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 [email protected]
Steven MandernachBureau Chief
Food and Consumer SafetyIowa Department of Inspections
Kimberly StrykerProgram Manager
Food Safety and SanitationState of Alaska