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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. Food Safety Modernization Act (FSMA).

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Food Safety Modernization Act

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  1. Food Safety Modernization Act Proposed Rules Tim Slawinski Food and Dairy Division Michigan Department of Agriculture and Rural Development

  2. Agenda • Overview of the Process • Content of proposed rules • Updates on feedback • Potential Concerns • To-Do List

  3. 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

  4. 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

  5. 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

  6. 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

  7. Exempt from Registration • Farms • Restaurants • Retail Food Establishments • Non-Profit Food Facilities • USDA Facilities • Transport Vehicles • Private Residence (Cottage Foods)

  8. 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 Amendment

  9. 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

  10. 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

  11. 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

  12. 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?

  13. Mixed-Type Facilities • On-Farm Manufacturing • Both Rules Apply • “Own RACs” vs. “Others RACs” • Change to “RAC Exemption” • CGMPs apply to mixed-type facilities

  14. CGMP Changes • Change from 110 to 117 • Editorial Changes • Remove Recommendations • Some changed to requirements • Add “Cross Contact” • Change to “RAC Exemption”

  15. 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

  16. Training • Personnel responsible for identifying sanitation failures or food contamination • Education and/or experience requirement • Food handlers and supervisors • “Appropriate” Training

  17. Food Safety Plan • Hazard Analysis • Preventive Controls • Hazards Reasonably Likely to Occur • Monitoring • Corrective Action • Verification (includes Validation) • Recall Plan

  18. Hazard Analysis • Biological, Chemical, Physical Radiological • Must include Environmental Pathogens in exposed RTE areas • Identify Hazards Reasonably Likely to Occur (not just CCPs).

  19. 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

  20. Food Safety Plan Cont. • Monitoring • Corrective Action • Verification • Validation required except for Allergen, Sanitation and Recall Plan • Direct Observation Required • Reanalysis every 3 years

  21. 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

  22. Recall Plan • Recall Plan Required • Notifications, Responsibilities, Effectiveness, Disposition • Request for comment on Mock Recalls • Traceability? • Mock Recall vs. Traceability Exercise

  23. Not “Required” FDA has requested comment on: • Product Testing • Environmental Monitoring • Supplier Verification

  24. 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

  25. Review the Proposed Rules • Determine the impact • Submit Comments to FDA by 5/16/13. • Start preparing for change

  26. 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

  27. Resources • FDA FSMA Proposed Rules page • http://www.fda.gov/Food/FoodSafety/FSMA/ucm334120.htm?source=govdelivery • Page Contents: • Fact Sheets on proposed rules • Full text of proposed rules • Links to submit comment to Federal Register

  28. Questions? Byron Beerbower MDARD (517) 241-0934 beerbowerb@michigan.gov Tim Slawinski MDARD (517) 335-3830 slawinskit@michigan.gov

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