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What s New in the 2009 FDA Food Code Future of Food Safety Nashville, TN

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What s New in the 2009 FDA Food Code Future of Food Safety Nashville, TN

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    1. What’s New in the 2009 FDA Food Code Future of Food Safety Nashville, TN Dan Redditt, R.S. Regional Food Specialist U.S. Food & Drug Administration What’s New in the 2009 FDA Food CodeWhat’s New in the 2009 FDA Food Code

    2. U.S. Food and Drug Administration Prevention - Intervention - Response 2 FDA Food Code Updates

    3. U.S. Food and Drug Administration Prevention - Intervention - Response 3 Summary of Changes NOW a 2 Volume Set! Cut leafy greens – definition, added to PHF (TCS food), instructions for handling Mechanically tenderized/injected – definitions, cooking Properly trained employees – allergen awareness “Critical items” changes – definition, throughout Food Code

    4. U.S. Food and Drug Administration Prevention - Intervention - Response 4 Summary of Changes Non-continuous cooking procedures Non-heated, forced air hand dryers CFP Sanitizer Committee recommendations 5 New supporting documents Combined Guides 3-B & 3-C (References & Instructions for Insp. Report)

    5. U.S. Food and Drug Administration Prevention - Intervention - Response 5 Chapter 1 Changes Chapter 1 – Definitions Add “cut leafy greens” Revise PHF (TCS Food) definition to add “cut leafy greens”

    6. U.S. Food and Drug Administration Prevention - Intervention - Response 6 Chapter 1 Changes Chapter 1 – Definitions Add “mechanically tenderized” Revise “injected” Add Non-continuous cooking

    7. U.S. Food and Drug Administration Prevention - Intervention - Response 7 Chapter 1 Changes New Risk Designations for Code Provisions Systematic risk evaluation process used to assign code provisions to one of 3 groups: Priority item - Provision has direct connection to preventing foodborne illness – compliance is a priority Priority foundation item - Provision provides foundation for, or enables compliance with, priority items Core item - Remaining provisions that promote sanitation and good retail practices

    8. U.S. Food and Drug Administration Prevention - Intervention - Response 8 New Risk Designations Priority item, denoted with a superscript P – P Priority foundation item, denoted with a superscript Pf – Pf Core item, a provision in this Code that is not designated as a Priority Item or a Priority Foundation item.

    9. U.S. Food and Drug Administration Prevention - Intervention - Response 9 Chapter 2 Changes Chapter 2 – Management & Personnel 2-102.11(A) – Change from no “Critical” violations to no “Priority” violations 2-103.11(L) – Employees are properly trained in food safety, including food allergy awareness

    10. U.S. Food and Drug Administration Prevention - Intervention - Response 10 Chapter 3 Changes Chapter 3 - Food 3-302.11(A) – Frozen, commercially processed & packaged raw animal foods stored or displayed with frozen, packaged RTE food

    11. U.S. Food and Drug Administration Prevention - Intervention - Response 11 Chapter 3 Changes Chapter 3 – Food (cont.) 3-401.11 – Cooking Added “mechanically tenderized” meats to ¶(A)(2) Comminuted meat cannot be served raw or undercooked from a child’s menu – new ¶(D)

    12. U.S. Food and Drug Administration Prevention - Intervention - Response 12 Chapter 3 Changes 3-401.14 Non-Continuous Cooking of RAW Animal Foods Initial heat- no more than 1 hour Cooled immediately Proper holding (refrig. or freezing) Cooked to 165°

    13. U.S. Food and Drug Administration Prevention - Intervention - Response 13 3-401.14 Non-Continuous Cooking of Raw Animal Foods (cont.) Written procedures Approval by Regulatory Authority Maintained in facility Describes monitoring, documentation & corrective actions Describes marking/identification Describes separation from RTE

    14. U.S. Food and Drug Administration Prevention - Intervention - Response 14 Chapter 3 Changes 3-502.12 – REDUCED OXYGEN PACKAGING W/O A VARIANCE: Sous Vide sealed immediately before cooking removed italics in (D) “Cook-Chill and (E) “Cheese” Raw vegetables included with raw meat & poultry as food with high levels of competing organisms

    15. U.S. Food and Drug Administration Prevention - Intervention - Response 15 Chapter 4 Changes Chapter 4 – Equipment, Utensils, and Linens 4-204.110(B) and 3-502.11(E) – Requires variance for display and storage shellfish tanks

    16. U.S. Food and Drug Administration Prevention - Intervention - Response 16 Chapter 4 Changes Chapter 4 – Equipment, Utensils, and Linens 4-501.114 - adds a reference to use according to EPA-registered labeling 4-501.114(A) – Adds concentration ranges in Table (for Chlorine) 4-501.114(B) – Lowers minimum temp. for iodine from 75şF to 68şF

    17. U.S. Food and Drug Administration Prevention - Intervention - Response 17 Chapter 4 Changes 4-501.114(C) and 4-703.11 Amends use of term, “EPA-approved manufacturer’s label use instructions” ? “EPA-registered label use instructions” “exposure time” ? “contact time”

    18. U.S. Food and Drug Administration Prevention - Intervention - Response 18 Chapter 4 Changes 4-904.13(A) & (B) – Except as specified, preset tableware shall be protected from contamination by being wrapped, covered, or inverted. Preset tableware may be exposed if: Un-used settings are removed when a consumer is seated; or Settings not removed when a consumer is seated are cleaned and sanitized before further use.

    19. U.S. Food and Drug Administration Prevention - Intervention - Response 19 Chapter 4 Changes 4-904-14 After being cleaned and sanitized, equipment and utensils shall not be rinsed before air drying or use unless: (A) The rinse is applied directly from a potable water supply by a warewashing machine that is maintained and operated as specified under Subparts 4-204 and 4-501; and (B) The rinse is applied only after the equipment and utensils have been sanitized by the application of hot water or by the application of a chemical sanitizer solution whose EPA-registered label use instructions call for rinsing off the sanitizer after it is applied in a commercial warewashing machine.

    20. U.S. Food and Drug Administration Prevention - Intervention - Response 20 Chapter 4 Changes 4-904.14 Rinsing Equipment and Utensils after Cleaning and Sanitizing Post-sanitizing rinse chemical warewashing machine EPA approved sanitizer must allow rinsing None available at this time Process for EPA approval: Chemical manufacturer must petition EPA or ask for amendment to existing approval to rinse off the sanitizer They must provide efficacy data Existing warewashing machines cannot be retrofitted – they must be designed to do this

    21. U.S. Food and Drug Administration Prevention - Intervention - Response 21 Chapter 5 Changes Chapter 5 – Water, Plumbing, and Waste 5-203.13 – Adds a new paragraph that toilets and urinals may not be used as service sinks.

    22. U.S. Food and Drug Administration Prevention - Intervention - Response 22 Chapter 6 Changes Chapter 6 – Physical Facilities 6-301.12 – Adds ¶ (D) to allow non-heated, fast blowing air for hand drying devices 6-501.111 – Establishment is expected to be free of pests

    23. U.S. Food and Drug Administration Prevention - Intervention - Response 23 Chapter 6 Changes Physical Facilities 6-501.18 – Cleaning of Plumbing Fixtures Plumbing fixtures such as handwashing sinks, toilets, and urinals shall be cleaned as often as necessary to keep them clean.

    24. U.S. Food and Drug Administration Prevention - Intervention - Response 24 Chapter 7 Changes Poisonous or Toxic Materials 7-204.12 Chemicals for Washing, Treatment, Storage and Processing Fruits and Vegetables, Criteria Added a new ¶ (B) that allows the use of ozone on fruits and vegetables according to 21 CFR 173.368

    25. U.S. Food and Drug Administration Prevention - Intervention - Response 25 Chapter 8 Changes Chapter 8 – Compliance and Enforcement 8-401.20(A) & (B) Performance- & Risk-Based (Inspection frequency) 8-403.10(B)(3) Documenting Information and Observations (Documentation on inspection forms) 8-405.11(A) & (B) Timely Correction 8-405.20(A) & (B) Verification and Documentation of Correction 8-406.11(A) Time Frame for Correction

    26. U.S. Food and Drug Administration Prevention - Intervention - Response 26 Potential Uses for Risk Designations P and Pf Prioritize time/effort to address factors that directly contribute to FBI and injury: Course content & focus in training courses Management systems, guides, SOPs Identify individuals to monitor P Items Immediate corrective action for P Items Achieve long term compliance for P Items Develop intervention strategies for specific P Items Focus on P & Pf Items on regulatory, audit and managerial walk through inspections

    27. U.S. Food and Drug Administration Prevention - Intervention - Response 27 Annex 1 Changes Annex 1 - Compliance and Enforcement Subpart 8-7 (New) – Recommends that Regulatory Authority must have requisite legal authority from statute to adopt rules and issue permits, etc.

    28. U.S. Food and Drug Administration Prevention - Intervention - Response 28 Annex 2 Changes Annex 2 - References New Supporting Documents: N – Storage and Handling of Tomatoes, 2007 O – Recommendations to Food Establishments for Serving or Selling Cut Leafy Greens P – Employee Health and Personal Hygiene Handbook Q – Risk Assessment Process and Spreadsheet to Redesignate Food Code Provisions R – Parameters for Determining Inoculated Pack/Challenge Study Protocols (NACMCF Report)

    29. U.S. Food and Drug Administration Prevention - Intervention - Response 29 R. NACMCF Report on Inoculation Study Protocols On NACMCF website Addresses inactivation and inhibition studies Contains information about Minimum expertise for designing, conducting and evaluating microbiological studies Pathogens of concern for growth studies Mathematical & growth models Criteria for inoculation studies Food product checklist with examples

    30. U.S. Food and Drug Administration Prevention - Intervention - Response 30 Annex 3 Changes Annex 3 – Public Health Reasons/Administrative Guidelines Multiple changes throughout Annex 3 corresponding to the code changes in each chapter

    31. U.S. Food and Drug Administration Prevention - Intervention - Response 31 Annex 7 Changes Annex 7 – Model Forms, Guides, and Other Aids Guide 3-B (Code Reference Sheet) & Guide 3-C (Inspection Report Marking Instructions) Updating Guides Adding Marking Instructions for GRPs Merging Reference Sheet and Marking Instructions Note: The FDA Standardization Procedure and Manual has been updated Standardization process will use the Food Code/CFP inspection form but will be expanded in places

    32. U.S. Food and Drug Administration Prevention - Intervention - Response 32 Annex 7 Changes Annex 7 – Model Forms, Guides, and Other Aids Chart 4-C – Summary Chart for Date Marking Corrected to remove reference to date marking at > 41°F - = 45°F for = 4 days

    33. U.S. Food and Drug Administration Prevention - Intervention - Response 33 2009 FDA Food Code on the FDA Retail Food Protection Website Direct link: http://www.fda.gov/RetailFoodProtection

    34. U.S. Food and Drug Administration Prevention - Intervention - Response 34 2009 FDA Food Code Ordering Information Order from: U.S. Department of Commerce Technology Administration National Technical Information Service 5301 Shawnee Road, Alexandria, VA 22312 (703) 605-6040; TDD: (703) 487-4639 refer to report number PB2009112613

    35. U.S. Food and Drug Administration Prevention - Intervention - Response 35 FDA FREE STUFF! NACMCF Challenge Study Personal Hygiene Guides ALERT Materials & DVD FIRST Materials & DVD

    36. U.S. Food and Drug Administration Prevention - Intervention - Response 36 Questions? Dan Redditt 404-253-1265 Alan Tart 404-253-1267 Donna Wanucha 704- 344-6116 Chris Smith 404-253-1264

    37. U.S. Food and Drug Administration Prevention - Intervention - Response 37 THANK YOU!

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