1. Standard 3 Breakout Session Inspection Protocol & Recall Program March 11, 2014 1:30 – 5:00 pm Richard Stephens Florida Department of Agriculture & Consumer Services Robin Henderson, PhD, RD/LDN Maryland Department of Health & Mental Hygiene Matthew Colson Florida State Department of Agriculture & Consumer Services Catherine Payne Feeney Rhode Island Department of Health Tressa Madden FDA ORA Office of Partnerships Michelle Motsinger FDA ORA Office of Partnerships Catherine White Rhode Island Department of Health

2. Agenda Welcome, Introductions, & Housekeeping Session Objectives Current Status of Standard 3 Implementation Inspection Protocol – Presentations, Exercise & Report Outs Recall Program Presentations, Exercise & Report Outs Q & A Summary

3. Housekeeping Honor time schedule Stay on topic Get input from everyone Be willing to share Respect different program cultures Do not reference specific audits Be creative, ask questions – parking lot Facilitators – responsible for process Participants – responsible for content

4. Session Objectives Generate a list of resources, best practices, lessons learned and challenges/recommendations for developing, implementing and monitoring an inspection protocol and a recall program. (Group Exercise Instructions) 1.Listen to presentations 2.Discuss and list suggestions on flip charts 3.Share your group’s suggestions with room

5. Standard Three

7. Focus Inspection Protocol Standard Section 3.3.b1-22 or Program Element 2.b state: Inspection Protocol – The State program has written policies and procedures for inspecting food plants that require the inspectors to: (items listed in Section 3.3.b1-22) 31% Yes for conformance on this element

8. Standard 3: Inspection Protocol March 11, 2014 1:30 pm Matt Colson Environmental Administrator Florida Department of Agriculture and Consumer Services

9. Background Inspection program overview MFRPS background Resources – RRT grant – FDA contract

10. Standard 3 Program Element 2.b

11. Standard 3 Background Initially inspection procedures were based on retail Added some language about manufactured food inspections to procedures At same time worked on standard 4 inspection report audit component

12. Inspections using old database Had no way to document all items from Appendix 4.6 during inspections Had coversheet for FDA contract inspections that was submitted with each inspection – Modified coversheet to add items from Appendix 4.6 that weren’t already being captured during inspection

13. Inspections using new database Developed inspection procedures based on new system and added 22 items Identified requirement of capturing Appendix 4.6 elements in system Developed addendum document to be attached to all manufactured food inspections

14. Moving Forward Recently developed new GMP inspection procedures based on IOM that address all 22 items in more detail than old procedures Developing detailed procedures for all inspection types (acidified, juice, seafood, etc.) Eventually revise inspection database to capture Appendix 4.6 information

15. Contact Information Matt Colson Environmental Administrator of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer Services Matthew.Colson@FreshFromFlorida.com

16. MFRPS Standard 3 Robin Henderson PhD, RD Chief, Center for Food Manufacturing MD State DHMH March 12, 2014

17. Requirements of Standard 3 Systems for: – Inspections – Recalls – Responding to Consumer Complaints – Responding to Industry Complaints about inspections, and a Recordkeeping System for all of the above

18. MD Risk Priorities and Inspection Frequencies High Priority: – Any food manufacturing plant (both PHF and non- PHF foods) – Inspect twice per year Moderate Priority – Food warehouses for PHF foods – Inspect once per year Low Priority – Ambient temperature food warehouses – Inspect once every other year

19. SOP Manual Contains our written protocols for all systems. Still a work in progress, particularly sections for recalls, complaints, sampling. Distributed to each inspector on paper, on a shared drive, and google drive for reference. Staff is trained using the elements contained in the SOP manual.

20. SOP Manual The list of inspection protocol items in 3.3b are all incorporated into our SOP, but not in the order listed there. Items in 3.3b can primarily be found in SOP Chapter 3, sections I-IV, and Chapter 6, sections II-VII. Chapter 6, section VIII is our process for plan reviews, both office and field reviews to help build out food safety hazards.

21. Staff Training Newly developed manual to define supervisory and field roles and responsibilities. Our FPSO is a new position developed to train new inspection staff and standardize all field staff on a routine basis. This position will also be in charge of desk audits. The FPSO is critical to help validate the items listed in 3.3b and identify weaknesses in our system.

22. Inspection Report Set up to help assure that: – Critical items are identified and corrected or the firm must close – GMPs, HACCP, and other records, are reviewed – All necessary information about the firm and the PIC are identified Report is uploaded to the office and the information captured in a database for management use

23. Challenges Balancing time spent in the firm to adequately: – View processes and practices – Cover area of responsibility Recordkeeping: – Inspection reports with detailed information – Clear and concise reports Transitioning to a “paperless” system – IT struggles – Field Personnel struggles – Management struggles

24. Successes We have a vision, and we are moving forward to meet our goals: – A top notch program – Meeting the standards – Coordinated effort with RRT, Lab, Local jurisdictions, and FDA

25. Contact Information Robin Henderson Chief, Center for Food Processing MD State Department of Health and Mental Hygiene Email: Robin.Henderson@Maryland.gov

26. Inspection Protocol Exercise Objectives Generate and share a list of: 1.Resources for developing an inspection protocol 2.Best practices to develop, implement and monitor/verify 3.Gaps identified in your plan and how you will address them 4.Challenges and recommendations 5.Lessons Learned - Program outcomes, measurements and/or benefits

27. Standard Three

28. Focus Recall Program Standard 3.3.c or Elements 3.b-3.e State: Recall System – Written procedures for sharing information – Written procedures for removing product – Written procedures for performing recall checks – Written procedures for maintaining records about recall information 3b46% yes on conformance 3c51% yes on conformance 3d49% yes on conformance 3e38% yes on conformance

29. Food Recalls Standard 3.3(c) Richard Stephens Environmental Scientist III Florida Department of Agriculture and Consumer Services March 11 th, 2014 1:30 PM

30. Program Elements The state program has a Food Recall system. Procedures for sharing information pertaining to recalls with other agencies. Procedures for promptly removing recalled foods from the marketplace. Procedures for performing recall audit checks. Procedures for identifying and maintaining essential recall information records.

31. Recall Policy “Big Picture” document that outlines recall activities – Health Hazard Evaluation and Recall Classification – Recall Strategy – FIRM initiated vs. FDACS requested recalls – Recall Communications and Status Reports – Recall Coordinator duties – Broad procedure

32. Sharing Information Conveyed in our Bureau’s Communication Plan Will notify appropriate state and federal agencies Instruct firm to submit RFR

33. Effecting the Recall Outlined in the procedures section of our policy FDACS has authority to STOP SALE any product deemed adulterated or held/produced in unsanitary conditions FDACS can only request a recall – Policy allows for Press Releases

34. Audit Checks Historically: – FDA form 3177 – Spreadsheet Presently: – Information is captured in our Food Inspection Management System (FIMS) – Use 3177 if performing for FDA

35. Records Historically – Spreadsheets – Case folders – Scanned copies of 3177’s Presently - FIMS

36. Recalls using FIMS All information pertaining to a recall is captured in FIMS – Recalling Firm – Product Info – Invoices and Records (to be implemented) – Audit Checks – Visits (to be implemented)

37. FIMS Recall Tab

38. Recall Details

39. Audit Details

40. Audit Details – Action and Status

41. FIMS Updates FIMS Recall items in development – Attachments – Visit Tracking – Request Tracking

42. Moving Forward FIMS Enhancements Step-by-Step procedures Sharing data captured in FIMS with state/federal partners

43. Contact Information Richard Stephens Environmental Scientist III Florida Department of Agriculture and Consumer Services (FDACS) Email: richard.stephens@freshfromflorida.com

44. Rhode Island‘s Food Recall Project Catherine Payne Feeney Catherine White Supervising Environmental Health Food Specialists RI Department of Health March 11, 2014 3:00 pm

45. Food Recall Problems & Challenges CDC epi curves reveal…. outbreaks and illnesses continue after a recall Recall audit checks reveal… products not always removed from commerce How can we… identify where product is remove it from commerce prevent Illnesses, deaths, disabilities reduce economic impact to industry

46. Grant Opportunity Improving Capacity to Protect Public Health in Response to a FD&C 1008 Notification 3 year grant RI proposed a project to… –Improve Recall Effectiveness –Improve Customer Notification –Ensure that RI Manufacturers/Stores have a Recall Plan –Minimize the Need for Recalls –Measure the Effectiveness of Recalls

47. New RI Law to Register Out of State Processors Already register out of state bottlers and frozen dessert manufacturers Last year, legislature mandated all out-of-state food processors selling food in RI be registered Opportunity to Identify foods products sold in RI so if a recall occurs, we will know where the product is and where it came from

48. First Steps Create Searchable Data Base to capture products and where they are sold  Letter to licensees regarding registration needed to be an approved source  New applicants asked to submit list of suppliers  Seasonal employees started scanning items in stores

49. Recall Policy and Procedures Policy Product Recall Triggers Roles including State, Federal Partners Procedures Recall Responses for Multiple Situations Communications during a Recall Conducting Audit Checks Expanding a Recall Terminating a Recall After Action Meeting and Report

50. Information Sharing Communications Plan that includes… – Department of Health Public Information Office – Federal Partners – Other States – Industry including licensees and associations – Public via press releases and/or website Press Release Template Attachment to P&P

51. Contact List State Partners Federal Partners Northeast State Partners Industry Associations Grocery Store Chain Operators

52. Recall Response Specific protocols were developed and/or revised for: – Product Seizure – Limiting Future Production – Controlling Product Distribution Channels Criteria to consider regarding expanding the recall

53. Recall Audit Checks Documentation regarding… – When audit check is warranted – Methods used to do audits (store visit, phone call, email, letter) – How to conduct audit check using form 3177 – What to do if recall ineffective Not just a survey, always get recalled product removed from commerce!

54. Information Collected & Record Keeping Staff person assigned to manage all recalls Database created to track recalls Information included… – product information – recall related activities Communications Findings Press Release

55. Data Tracking

56. Metrics Metric 1: Number of illnesses from consuming contaminated/recalled product in Rhode Island after a recall If illnesses occur, why? Did the consumer not learn of the recall? Did the consumer buy recalled product after the recall and, if so, why? Metric 10: Name and number of food store chains with shopper/loyalty cards who directly notify consumers who bought recalled products and method of notification Notify FDA of findings, Share with other states

57. Next Steps Work with retail chains with shopper/loyalty cards  Identify and directly notify consumers who purchased unsafe foods through: Text messaging Emails Automatic phone calling Other direct notification techniques

58. Contact Information Catherine Payne Feeney Catherine White Supervising Environmental Health Food Specialists Rhode Island Department of Health Email: catherine.payne-feeney@health.ri.govcatherine.payne-feeney@health.ri.gov catherine.white@health.ri.gov

59. Recall Program Exercise Objectives Generate and share a list of: 1.Resources for developing a recall program 2.Best practices to develop, implement and monitor/verify 3.Gaps identified in your program and how you will address them 4.Challenges and recommendations 5.Lessons Learned - Program outcomes, measurements and/or benefits

60. Q & A

61. Contact Information Richard Stephens Richard.Stephens@freshfromflorida.com 850.245.5520 Robin Henderson, PhD, RD/LDN Robin.Henderson@maryland.gov 410.767.8451 Matthew Colson Matthew.Colson@FreshFromFlorida.com 850.245.5544 Catherine Payne Feeney Catherine.Payne-Feeney@health.ri.gov 401.222.7717 Tressa Madden Tressa.Madden@fda.hhs.gov 405.609.8738 Michelle Motsinger Michelle.Motsinger@fda.hhs.gov 303.236.3057 Catherine White Catherine.White@health.ri.gov