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Food Safety Modernization Act
MiFOOD2017
Tim SlawinskiFood and Dairy Division
April 18, 2017
Food Safety Modernization Act
• Signed into Law January 4, 2011• 41 Sections• Focus on Prevention• Ensure the US Food Supply is Safe
Preventive Focus
Food Safety Incident
Unacceptable Condition
Breakdown or Lack of Preventive Plan
• Preventive Controls for Human Food• Preventive Controls for Animal Food• Produce Safety• Foreign Supplier Verification• Third Party Auditor• Sanitary Transportation• Intentional Adulteration
FSMA 7 Rules
Preventive Controls
Preventive Controls
• Who’s Covered:– Manufacture/Process, Pack or Hold Food
• Who’s Not Covered:– Restaurants– Retail– Farms– Non-Profits– Other
Modified Requirements
• Less than $1M in Annual Sales:• Submit Documentation to FDA every 2 years:
– Attestation of “Qualified Facility” status and• Plan is in place to control hazards
or• Compliance with State, Local, County, or other food
safety regulations.– Licenses, inspection reports, or other
Preventive Controls Timeline
• Large “Other” Businesses: >500 employees• Small Businesses: <500 employees• Very Small Businesses: <$1M Annual Sales
Large Businesses 9/17/2016
Small Businesses 9/17/2017
Very Small Businesses 9/17/2018
Good Manufacturing Practices (GMPs)
• Employee Health and Hygiene• Plant and Grounds• Sanitary Operations• Equipment and utensils
What’s Wrong?
PC What’s Required
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
Program Allergen Control
Sanitation Control
Including procedures formonitoring, corrective actionand verification, as appropriate
Verification & Record-keeping
Food Safety Plan
Hazard Analysis
Preventive Controls
Parameters & Values
Monitor
Corrections/ Corrective
Action
Produce Safety
• First food safety regulation specific to growing and harvesting
• Prior regulations cover adulteration• Addresses Microbiological Risks
Produce Safety
• Who’s Covered?– Produce that is typically eaten raw.
• Who’s Not Covered?– RAC’s Not typically eaten raw– RAC’s destine for Commercial processing– On-farm consumption– Farms with <$25,000 Annual Food Sales– “Qualified Facilities” have modified requirements
• <$500K & 50% of sales local (in-state or within 275 mi.)
Produce Safety
• What’s Covered?– Agricultural Water – Biological Soil Amendments of Animal Origin– Equipment, Tools and Buildings– Animals in the Growing Area– Health and Hygiene
Produce Safety
• Compliance Dates
• Large Business: > $500K in Annual Sales• Small Business: $500K-$250K in Annual Sales• Very Small Business:$250K-$25K Annual Sales• Exempt: <$25K in Annual Sales
Large Businesses2018
Small Businesses2019
Very Small2020
