Food Safety Modernization Act - The Right Place€¦ · Food Safety Modernization Act MiFOOD2017. Tim Slawinski. Food and Dairy Division. April 18, 2017. Food Safety Modernization

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

Questions? Tim Slawinski

MDARD(517) 420-5364

[email protected]