Food Safety Modernization Act

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