Food Safety Modernization Act
Proposed Rules
Tim Slawinski
Food and Dairy Division
Michigan Department of Agriculture and Rural
Development
Agenda
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Overview of the Process
Content of proposed rules
Updates on feedback
Potential Concerns
To-Do List
February 2013
Food Safety Modernization Act
(FSMA)
• Signed into Law January 4, 2011
• Proposed rules published January 16, 2013
– Standards for Produce Safety
– Preventive Controls for Human Food
• Animal feed rules yet to be released
• 120 day public comment period (ends 5/16/13)
• FDA review of comments
• Final rules published
February 2013
Compliance Dates
• Preventive Controls:
– 1 Year – Large Businesses
>500 Employees
– 2 Years – Small Businesses
<500 employees
– 3 Years – Very Small Businesses
3 options being considered
<$1M, <$500K, <250K
February 2013
Who’s in and Who’s out
• FDA Registration for Bioterrorism Act
– Facilities Required to Register are in
– 2 Levels of Exemptions:
• Not Required to Register
– Full Exemption
• Required to Register, but Exemption in Rule
– Partial Exemption
January 2013
Registration Required
• Firms that Manufacture, Process, Pack or
Hold Human Food.
– Confusion over who must register
• Farm Activity vs. Manufacturing
• Mixed-Type Facilities (Farm and Manufacturing)
– Guidance documents now available
February 2013
Exempt from Registration
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Farms
Restaurants
Retail Food Establishments
Non-Profit Food Facilities
USDA Facilities
Transport Vehicles
Private Residence (Cottage Foods)
January 2013
Partial Exemptions in the Rule
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Juice, Seafood & Low Acid Canned Food
Certain types of storage facilities
Alcoholic Beverages
Dietary Supplements
Low-Risk On-Farm Processing
Very Small Businesses
Tester Amendment
February 2013
Modified Requirements
• Qualified Facilities:
– Very Small Businesses
– Tester Amendment
• <$500K annual sales and
• 50% of sales local (in-state or within 275 mi.)
• Submit Documentation to confirm:
– Firm meets “Qualified Facility” requirements
– Compliance with State Law
– Label Requirement
February 2013
Content of Preventive Controls
• Changes to 21 CFR 110 (CGMPs)
– Applies to most partially exempt facilities
• Food Safety Plan Required
– Similar to HACCP + Pre-req. programs
• Hazard analysis, preventive controls, monitoring,
corrective action, verification, validation
February 2013
Warehouse
• Packaged Food:
– CGMPs apply
– Exempt from Food Safety Plan
• Modified Requirements for Refrigerated
• Raw Agricultural Commodities
– Exempt from CGMPs
– Exempt from Food Safety Plan
• Except for fruits and vegetables
February 2013
Warehouse
• RAC Fruits and Vegetables
– Exempt from CGMPs
– Food Safety Plan Applies
• Boxed Fruit in a CGMP Warehouse?
– Is a Banana Box considered “Packaged”?
• WIP or Bulk Ingredient Storage?
January 2013
Mixed-Type Facilities
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On-Farm Manufacturing
Both Rules Apply
“Own RACs” vs. “Others RACs”
Change to “RAC Exemption”
– CGMPs apply to mixed-type facilities
February 2013
CGMP Changes
• Change from 110 to 117
• Editorial Changes
• Remove Recommendations
– Some changed to requirements
• Add “Cross Contact”
• Change to “RAC Exemption”
February 2013
Cross Contact
• Wearing outer garments suitable to the
operation in a manner that protects
against the contamination of food, foodcontact surfaces, or food-packaging
materials, and to protect against the
cross-contact of food
February 2013
Training
• Personnel responsible for identifying
sanitation failures or food contamination
– Education and/or experience requirement
• Food handlers and supervisors
– “Appropriate” Training
February 2013
Food Safety Plan
• Hazard Analysis
• Preventive Controls
– Hazards Reasonably Likely to Occur
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Monitoring
Corrective Action
Verification (includes Validation)
Recall Plan
January 2013
Hazard Analysis
• Biological, Chemical, Physical
Radiological
• Must include Environmental Pathogens
in exposed RTE areas
• Identify Hazards Reasonably Likely to
Occur (not just CCPs).
January 2013
Preventive Controls
• Hazard Reasonably Likely to Occur
• Must Significantly Minimize or Prevent
• Must Include “as appropriate”:
– Process controls
– Food Allergen Controls
– Sanitation Controls (Food Contact)
– Recall Plan
– Others
January 2013
Food Safety Plan Cont.
• Monitoring
• Corrective Action
• Verification
– Validation required except for Allergen,
Sanitation and Recall Plan
– Direct Observation Required
– Reanalysis every 3 years
January 2013
Qualified Individual
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Trained in Risk-Based Preventive Controls
Prepare the food safety plan
Validate Preventive Controls
Review records effectiveness
Review corrective actions
Perform the reanalysis of the Food Safety
Plan
February 2013
Recall Plan
• Recall Plan Required
– Notifications, Responsibilities,
Effectiveness, Disposition
– Request for comment on Mock Recalls
• Traceability?
– Mock Recall vs. Traceability Exercise
February 2013
Not “Required”
FDA has requested comment on:
• Product Testing
• Environmental Monitoring
• Supplier Verification
February 2013
Industry Coordination
• FDA Listening Session
– April 24, 2013.
– MDARD to host 1 of 5 in the nation.
– Direct contact with FDA decision makers.
– Limited on-site space available.
– Webinar format for those off-site.
• Food Processors Working Group
– April 10, 2013
February 2013
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Review the Proposed Rules
Determine the impact
Submit Comments to FDA by 5/16/13.
Start preparing for change
February 2013
Value of Feedback
• Why submit comment to the FDA?
– Help to shape the final rules
– Guidance Documents
• Why inform MDARD?
– Connected to other state agencies
February2013
Resources
• FDA FSMA Proposed Rules page
– http://www.fda.gov/Food/FoodSafety/FSMA/ucm3
34120.htm?source=govdelivery
• Page Contents:
– Fact Sheets on proposed rules
– Full text of proposed rules
– Links to submit comment to Federal
Register
February 2013
Questions?
Byron Beerbower
Tim Slawinski
MDARD
(517) 241-0934
beerbowerb@michigan.gov
MDARD
(517) 335-3830
slawinskit@michigan.gov