1. FSMA TRAINING Industry Recall Readiness BEST PRACTICES

2. Warm Welcome Kathy Gombas Senior Advisor CFSAN Office of Food Safety 2

3. FSMA Rule Readiness Training 2016 Sessions 3

4. Agenda Kathy Gombas, CFSAN/OFS  Introduction, Q&A and Wrap Up Cecilia Wolyniak, ORA  FDA Perspective – PC Rule Requirements Amy Philpott, Watson Green LLC  Industry Recall Readiness Best Practices 4

5. FDA's Responsibilities During a Recall Event Cecilia M. Wolyniak FDA Office of Enforcement and Import Operations

6. Overview Basic recall definitions Requirements for a recall plan FDA's roles and responsibilities in a recall Location of guidance on FDA’s website

7. Definitions Voluntary Recall Definition (21 CFR 7.3): Recall means a firm’s removal or correction of a marketed product(s) that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.

8. Definitions Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location Removal means physical removal from where a product is used or sold to another location for repair, relabeling, destruction, etc.

9. Definitions (Cont.) A subrecall refers to the action taken by a recalling firm’s consignees to extend the recall to subsequent levels of distribution, provided that the consignee did not further manufacture the recalled product. Recalling firmDistributor Retailer

10. Definitions (Cont.) If the consignee further manufactured the product (repacked or used as in ingredient), they have created a new product and need to consider if they need to initiate their own recall Initial Recalled Product Consignee used in packaged salad – New Recall! Retailer

11. Definitions (Cont.) Recall Classification: Numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

12. Definitions Class I: reasonable probability of serious adverse health consequences or death. Class II: temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III: not likely to cause adverse health consequences.

13. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls (PC) Rules for Human Food (HF) and Animal Food (AF) Final rules issued: September 17, 2015 Background

14. Who is Covered by PCHF? Facilities that manufacture, process, pack or hold human food In general, facilities required to register with FDA under sec. 415 of the FD&C Act – Not farms or retail food establishments Applies to domestic and imported food Some exemptions and modified requirements apply

15. Who is Covered by PCAF? In general, facilities that manufacture, process, pack or hold animal food – Facilities required to register with FDA under sec. 415 of the FD&C Act – Not farms Applies to domestic and imported food There are some exemptions and modified requirements for certain facilities.

16. Requirements for a Recall Plan PCHF (117.139) and PCAF (507.38) For food with a hazard requiring a preventive control (a) Establish a written recall plan (b) Include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions: (1) Directly notify the direct consignees of the food being recalled (2) Notify the public about any hazard presented by the food (3) Conduct effectiveness checks to verify that the recall is carried out; and (4) Appropriately dispose of the recalled food

17. District Recall Coordinator Center Recall Coordinator Office of Enforcement and Import Operations DRC Initial POC / provides guidance Document recall / packages report Refers to Center Recall Coordinator (CRC ) CRC Review recall strategy Classify hazard Assign recall number OEIO FDA-wide policy & procedure Cross-cutting recall projects Consultants to IT / recall data system staff Post announcements to FDA.gov Recall Coordinator Roles in FDA

18. FDA Recall Process Firm provides initial information to district; district provides guidance to firm, including need for public warning District sends recall alert to center and Office of Enforcement and Import Operations (OEIO) recall staffs District obtains additional information and documentation District submits recommendation to center and OEIO recall staffs; documentation to center staff Center conducts health hazard evaluation and classifies; recall appears in the Enforcement Report District monitors until termination (Center must concur with class I termination)

19. Guidelines for Voluntary Recalls 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibility Guidance for firms on development of recall strategy (depth, public warning, effectiveness checks) and on recall communications with customers and FDA Describes procedures for FDA: assessing hazard of recalled products, publicizing recalls, termination of recalls

20. FDA Recall Guidance for Industry FDA Link to Recall Guidance for Industry – List of district recall coordinators – Links to recall regulations – Templates for recall letters and response forms – Templates for press releases – Additional recall guidance

21. Thank you! Cecilia M. Wolyniak 301-796-8209 Cecilia.Wolyniak@fda.hhs.gov

22. Questions & Answers Kathy Gombas, CFSAN / Office of Food Safety Q & A – Use the Adobe Connect pod to type your questions

23. Events for sharing industry best practices & FDA perspectives: Upcoming events Truth or Fiction: 10 Facts about Industry Third Party Audits - April Points of Contact: Kathy Gombas or Jenny Murphy.

24. FSMA Rule Readiness Training Resources FDA Employees: http://inside.fda.gov:9003/CFS AN/CFSANStaffCollege/FoodS afetyModernazationAct/ucm449 582.htm State Employees: https://www.foodshield.org /blog-training-news/

25. Feedback To submit a question about FSMA, visit FSMA Website and go to Contact Us FSMA Website FSMA Website Registered participants will receive an evaluation survey in two days.

26. THANK YOU FOR ATTENDING FSMA TRAINING Industry Recall Readiness BEST PRACTICES