Download - Food Safety Modernization Act
Food Safety Modernization Act
Proposed Rules
Tim Slawinski
Food and Dairy Division
Michigan Department of Agriculture and Rural Development
Agenda
• 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
• Farms
• Restaurants
• Retail Food Establishments
• Non-Profit Food Facilities
• USDA Facilities
• Transport Vehicles
• Private Residence (Cottage Foods)January 2013
Partial Exemptions in the Rule
• Juice, Seafood & Low Acid Canned Food
• Certain types of storage facilities
• Alcoholic Beverages
• Dietary Supplements
• Low-Risk On-Farm Processing
• Very Small Businesses
• Tester AmendmentFebruary 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
• 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, food-contact 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
• 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
• 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
• 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
Industry Coordination
• 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
MDARD
(517) 241-0934
Tim Slawinski
MDARD
(517) 335-3830
