Food Recall Train-the-Trainer

Transcription

1 Food Recall Train-the-Trainer FOOD MANUFACTURING WAREHOUSING FOOD PROCESSING WAREHOUSING DEPARTMENT OF CONSUMER PROTECTION FOOD & STANDARDS DIVISION IN PARTNERSHIP WITH MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH AND SALEM ENTERPRISE CENTER SALEM STATE UNIVERSITY 165 Capitol Avenue Hartford, CT

2 Department of Consumer Protection William M. Rubenstein, Commissioner Michelle H. Seagull, Deputy Commissioner Established Statutory authority - CGS Chap. 416, Section 21a-1 Central Office Capitol Avenue, Hartford, CT Disclaimer: This course was adapted and provided in 2013 by the Connecticut Department of Consumer Protection. Lisa Bellamy Fluker, Trainer, Virginia Veneziano, MFRPS Program Coordinator Frank Greene, Director, Food and Standards Division Contributions by: The State of Connecticut Department of Public Health, Food Protection Program, Rhonda L. Wisniewski 2

3 I. Table of Contents Acknowledgements.ii Table of Contents.3 Introduction to Participant Manual..4-5 Overview of FRTT Program...6 Module Overview...7 Course Components Training Schedule...10 Welcome/Introductory Exercise Agenda.15 Survey Results*...16 FDA Welcome..17 CT Department of Public Health *...18 Module I Module II Module III Tips, Contact Information, Links Appendices Recall Toolkit/Case Study* * Hand Outs- CT Department of Public Health Presentation/Survey Results/Case Study 3

4 The Participant Manual Organization of the participant manual. Your manual contains all of the materials you will need to participate in the seminar. It may also serve as a reference manual when you return to your office. The following is a breakdown of your manual: Table of Contents This lists items in the manual with corresponding page number Introduction to the Participant Manual Training Schedule This section provides background information of the Food Recall Train-the-Trainer (FRTT) program and logistics of course. This is an outline of the content and the timing of each section Modules 1-3 Each module contains slides and material covered on that topic as well as room for notes. Appendices This section includes food recall toolkit, copies of regulations, fact sheets, glossary 4

5 I. Introduction to Participant Manual Food Recall Train-the-Trainer (FRTT) The Food Recall Train-the-Trainer (FRTT) program is an interactive curriculum comprised of three modules. In each module participants will explore recall best practice through a range of activities that vary in complexity, content and application. The purpose of this workshop is to build industry recall competency and enhance recall preparedness across the State of Connecticut. Best practice and contextual-based exercises will be used to stimulate dialogue, review food safety standards in order to improve overall food recall preparedness. You will use templates found in the recall toolkit throughout the seminar. Reference the toolkit. It will be used in conjunction with workshop activities. FRTT Recall Toolkit The FRTT toolkit is a set of materials designed to provide practical templates, tools, and form samples. These tools will assist you in planning, monitoring, responding, executing and terminating a recall. The goal of the toolkit is to enable food recall accountability across industry. 5

6 II. Overview of FRTT Program The FRTT Seminar was designed in October 2013 to provide an understanding of recalls and recall procedures. Modules have an interactive component to provide real life application of best practices and regulatory requirements and overall recall effectiveness to participants. The FRTT program will be launched through a pilot process. Feedback will be received from seminar attendees and will be reviewed, considered, and if feasible integrated into content moving forward. The course will be available in the spring 2014 and will be delivered by DCP Instructors. Prerequisite: There are no prerequisites required for this seminar. 6

7 Module Overview Modules Module 1 focuses on Food Recall basics, regulatory provisions, definitions and the Food Safety Modernization Act (FSMA). Module 2 focuses on preventative controls, classifications and industry best practice. Module 3 focuses on food recall partnership, stakeholder engagement, role and accountability, industry & regulatory relations, recall planning, recall strategic communication and a food recall simulation. 7

8 Course Components The FRTT seminar is designed to be a highly interactive, introductory level seminar. Each module includes: instruction, activity and report back functions for each table team. Instruction The instructor will conduct course in standard classroom style. However, in the future, DCP would like to design a FRTT webbased course. Instructor will lead discussion and guide activities of the entire group in small and large group format. Activity You will engage in small working groups for hands-on experience with concepts, procedures, and specific recall requirements. You will be asked to participate in group discussion, role play, or complete an exercise to capture individual learning. Case Study: Food Recall Simulation (use toolkit/handouts for this activity) 8

9 Report Back Your group will be asked to prepare a basic, bulleted report on each activity assigned to your team. As reports are shared, you will have an opportunity to provide feedback and learn from others and the instructor, as the activities are debriefed. III. Logistics Staff. In most cases, the training courses will be delivered by one instructor or may be delivered in an online format. Materials All materials will be provided, however, if you would like to use existing recall plans, strategies or other tools your organization uses for recalls, please feel free to do so. Please let us know if you do not receive a name tent, or binder. *Each team table will have a flip chart or easel, newsprint and markers for activity. Breaks and Meals Short breaks of 10 minutes will be announced by your instructor. Please note the announced times for these breaks and return to the workshop accordingly. Lunch will be on your own. 9

10 Seminar Schedule Content Area Time Objectives Registration Welcome/Introductions/ Background & Opening Activity Survey review & State, Fed, Local Policy Review/FDA Welcome-Comments CT Department of Public Health Coffee Break Defining a Recall (Review) Trends in Recalls Dialogue with FDA Coffee Break How Do We Make It Better? Investigation/Recall Process Best Practice in Recalls 7:30 am- 8:00 am 8:00 am- 8:30 am 8:30 am- 8:40 am 8:40 am 9:00 am 10 minutes 9:10 am- 9:40 am 9:40 am-9:50 am 9:50 am-10:00 am 10 minutes 10:10 am-10:25 am 10:25 am-10:35 am 10:35am-11:00 am Sign in, badging, distribute bagged educational materials Getting to Know You Activity Review Pre-Assessment data, review Federal, State & Local policy Review Food Born Outbreaks/ Maintaining consumer confidence USDA/FDA definitions, examples, Review data on recalls to identify trends Review Frequent Q& A s Brainstorming Session/Collect Feedback from Industry Review Food Safety Investigation & Recall Process Case Study: Deloitte & Touche - Best Practice Study in Food Re- Coffee Break Roles, Strategy, Creating a Recall Plan 5 minutes 11:05am-12:00 pm Review Federal, State, Local Stakeholder Roles, Recall Strategy Lunch Break Recall Planning Activity Coffee Break 1 hour 1:00pm-2:00 pm 10 min Practice recall plan development Food Recall Statistics/Impact 2:10pm-2:20 pm Review of Recall Statistics Effective Food Recall Management 2:20pm-2:30 pm Review Stakeholder Engagement, Communication & Guidance docu- Recall Simulation Prep/Activity 2:30pm-2:45pm/2:45 pm-3:30pm Food Recall Simulation Activity Wrap Up 3:30pm-4:00 pm Total Time 8 hours 10

11 Building Partnership Capacity in Recall Response Outcomes Federal, State, Local, Tribal and Industry collaboration 11

12 WELCOME TABLE INTRODUCTIONS INTRODUCTORY EXERCISE 12

13 ACTIVITY Getting to Know you Activity Directions: Introduce yourself to your partner/triad, share your name, agency and your role in the food service industry. Use half sheet handout to ask one or more questions of your partner. What food safety factors do you have in common? Please share similarities and differences. Can you share one food safety challenge you have with your partner? If you are non-industry, in what way can your organization enhance outreach regarding food recalls. Identify a scribe to collect common themes. 13

14 Department of Consumer Protection The mission of the Department of Consumer Protection is to ensure a fair and equitable marketplace as well as safe products and services for consumers in the industries that it regulates. 14

15 Agenda Explore recall response best practice Review federal, state and local policies regarding recalls Practice recall response through simulation activity Review key terminology, forms, planning templates for an effective recall Discuss stakeholder collaboration Share industry success of effective recall execution 15

16 FOOD RECALL PRE-WORKSHOP SURVEY RESULTS 16

17 U.S. Food and Drug Administration A focus on maintaining consumer confidence 17

18 Changing Demographic of U.S. Food Supply 15% of U.S. food is imported 75% of all seafood is imported 20% of vegetables are imported 50% of all fruit is imported Concern New pathogens Higher % of individuals at risk 18

19 MODULE I 19

20 RECALLS What are they? A company s removal from distribution and sale of a marketed product that may be unsafe, adulterated, contaminated or mislabeled; or that a government agency considers to be in violation of State or Federal law, and against which the agency could initiate legal action, e.g., seizure. 20

21 State Authority Most states do not have recall authority or have selective authority All states have the authority to embargo foods deemed to be contaminated or misbranded. 21

22 General Recall Information Foods Drugs, Cosmetics Medical Devices USDA regulated products General Product Safety* 22

23 NOT a Recall? Market Withdrawal Stock Recovery 23

24 Market Withdrawal vs. Recall Market Withdrawal (MW) Minor Violation/No FDA penalties Improper Labels Inefficient Packaging Safety Concern NO Safety Threat Use Communication Tools to reduce reputation damage Minimize Risk (Brand Integrity) & Expense Need Recall Plan & Strategy Example: Hartz Chicken Chews Recall Violative, Unadulterated, Misbranded Loose seals, seams, misbranding Spoilage organisms, pathogens, undeclared allergens Safety Threat: Class I, II, or III Use Communication Tools to reduce reputation damage Minimize Risk (Brand Integrity) & Expense Need Recall Plan & Strategy Example: Voluntary Tuna Recall 24

25 What may prompt a food Recall? Company Initiated (Voluntary) Consumer/Trade Market Withdrawal Unsatisfactory Investigation Referrals from Gov t Agencies Global 25

26 More Recall Triggers Media/Internet Associations 26

27 Types of Recalls Firm Initiated USDA (FSIS) FDA requested/mandated 27

28 FSIS (OFO) Office of Field Operations 28

29 FDA Regions 29

30 Classification of USDA/FDA Recalls USDA FDA FIRM USDA/FSIS- notification to the appropriate regional office within 24 hours of initiating the recall. Health Hazard Evaluation (HHE) to assign Recall Classification (Both FDA/USDA use similar criteria) FSIS RMS recommend the depth of recall. FSIS requests recall strategy, reviews it and suggest changes. Assigns a recall classification as a Class I, II, or III by committee. * Urgent situationsagency notifies company of specific violation, HHE classification and recommended recall strategy. Central Recall Unit (CRU assigns a recall classification as a Class I, II, or III recall Requests basic information from recalling firm ( recall strategy) FDA/USDA firms that recall should immediately notify the appropriate FDA/USDA office. 21 CFR Part 107 (see toolkit) Press Releases * See USDA/FDA example in Appendix: Recall Toolkit Standard in all Class I Recalls Standard in all Class I Recalls Develop & Distribute Recall Notification with FDA Effectiveness Checks (EC) Determines number of EC s (MOU) State agencies may assist FDA in EC s Know EC procedure and be prepared to answer questions Recall Action May participate in disposal or reconditioning Firm Responsibility Disposal/Correction 30

31 What is an Effectiveness Check? FSIS determines the number of effectiveness checks to be conducted on a case-by-case basis. In contrast to FDA, FSIS would conduct the effectiveness checks itself rather than relying on the company to do, using the following criteria: Health Hazard Evaluation (HHE) Results of the initial effectiveness check Recall class Cooperation of the recalling company * 31

32 USDA Policies that Relate to Recalls 9 CFR (regulated by USDA) HACCP Plan in operation, including plan itself: A Food Safety System per PHIS Directive Hazard analysis HACCP plan Supporting documentation HACCP records 32

33 7 PRINCIPLES OF HACCP There are seven fundamental HACCP principles: Principle 1 Conduct a hazard analysis. Principle 2 Determine the critical control points. Principle 3 Establish critical limits. Principle 4 Establish monitoring procedures. Principle 5 Establish corrective actions. Principle 6 Establish record-keeping and documentation procedures. Principle 7 Establish verification procedures. 2007, Purdue University, Purdue Department of Food Science, 33

34 Food Safety Pyramid HACCP PLAN 7 PRINCIPLES SANITATION STANDARD OPERATING PROCEDURES (SSOP S) PEST RECALL CALIBRATION GMP TRAINING CLEANING & SANITATION WASTE 34

35 HACCP Highlights Training programs for managers and workers Audit programs Written records (batch, sanitation) Validation of control measures Written sanitation standard operating procedures Food label review and control program Testing of incoming raw materials In process materials 35

36 USDA Policies that Relate to Recalls 9 CFR Notification Provide DO with type, amount, origin and destination of the adulterated or misbranded product. 77 FR require establishments to notify local FSIS DO within 24 hours of learning or determining that an adulterated or misbranded meat or poultry product received by or originating from the official establishment has entered commerce. 36

37 How Do USDA & FDA define a Recall?. USDA DEFINES A RECALL as: A firm s removal of distributed meat or poultry products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of the FMIA or the PPIA. Recall does not include a market withdrawal or a stock recovery FDA DEFINES A RECALL as: Firms voluntary or FDA requested or mandated removal/correction of a marketed product in violation of the FD & C Act and against which FDA would initiate legal action. 37

38 Recall Classification Class l Class ll Class lll 38

39 Class I Situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 39

40 Previous Class I Recalls Peanut Butter contaminated with Salmonella Under-processed canned chili that contained Clostridium botulinum toxin Smoked salmon contaminated with Listeria monocytogenes (Lm). Ice Cream (undeclared peanut- derivitive) 40

41 Recall Classification Class l Class ll Class lll 41

42 Class II Situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 42

43 Previous Class II Recalls 2007, Castleberry s Food Company, Hot Dog Chili Norwalk Virus (1968) Roasted Red Bell Pepper Plus Powder 50 lbcarton 43

44 Class l Recall Classification Class ll Class lll 44

45 Class III Situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 45

46 Previous Class III Recalls Decomposition Filth Mold Contamination- off taste/color Undeclared sulfites Minor Labeling Problems Economic Fraud 46

47 Phases of a Food Recall Five Stages of a Food Recall: Investigation, Confirmation of Hazard Decision-Making regarding Risk Management Strategy Recall Implementation Verification of Recall Effectiveness Follow-Up 47

48 The Economic Impact Pattern of recall losses nationally and globally AIG recently launched a free service to estimate cost of product recalls Average cost of a recall to a food company 10 million in direct costs 1 year after spinach, peanut recalls, almost three quarters of consumers stopped purchasing those products. 48

49 15 second FIRE DRILL 49

50 A SYSTEMS APPROACH 50

51 Food Safety Modernization Act (FSMA) 51

52 Food Safety Modernization Act (FSMA) 2011 Mandate shifts agency food safety activity from responding to prevention Cooperative agreement to build partnerships across and between federal & local agencies and Industry Risk-based inspections The authority to order a mandatory recall Detect, Investigate, Control, Prevent 52

53 Major Elements of FSMA? FSMA beyond HACCP Preventative Controls Inspection and Compliance New system of import oversight Emphasizes partnerships Response 53

54 Risk-Based Preventive Controls 54

55 How Does FSMA Impact Me? Raised accountability for food safety plans (FSMA, section 103) Proactive contamination prevention (Implementation of Preventative Control Measures) Review of current recall and replacement strategy 55

56 WHAT DO I DO? PRODUCT JUICE, SEAFOOD & LOW ACID CANNED PRODUCTS ACTION (CONTINUE YOUR HACCP FOOD CRITICAL CONTROL POINT PLANS/SYSTEMS.) FRUIT & VEGETABLE PRODUCERS Preventative Controls/Science and Risk-Based MEAT & POULTRY FOLLOW USDA HACCP GUIDELINES 56

57 Policies that Relate to Recalls FDA Regulatory Procedures Manual (RPM) FD&C Act, 518 (e) 21 CFR (regulated by FDA) Section 103, Hazard analysis and risk-based prevention controls, FSMA Section 206, FSMA, January 4, 2011(Mandatory Recall Authority) 57

58 CFR Title Recall policy. (a) Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. This section and 7.41 through 7.59 recognize the voluntary nature of recall by providing guidance so that responsible firms may effectively discharge their recall responsibilities. These sections also recognize that recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products by setting forth specific recall procedures for the Food and Drug Administration to monitor recalls and assess the adequacy of a firm's efforts in recall. (b) Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled. (c) Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing. [43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000] 58

59 Food Recalls: Trends Factors Contributing to Increased Recalls Growing complexity in the U.S. Value chain Tighter regulatory requirements Increased velocity of product launches Enhanced detection technology 59

60 Questions for USDA/FDA Complete index cards at your table Activity Time: 10 minutes Large Group activity Activity Objective: To share new information and answer questions about the recall process. Materials: Index Cards, Pens, Pencils Outcome: An exchange between government agencies and industry 60

61 MODULE 2 61

62 How Do We Make It Better? 62

63 Food Safety Investigation and Recall Process Issue Identification Feedback Loop Recall Notification Product Replacement Product Removal and Destruction 63

64 Best Practice in Issue Identification Adapted from: Deloitte LLP consumer product supply chain study, March

65 Recall Notification Leading Practices Timely multi-medium recall notification procedures Maintain updated customer contact lists Leveraging information from consumer loyalty programs to notify customers 65

66 FDA / USDA Notification 66

67 FDA Example: Exhibit 7-4 MODEL RECALL LETTER (GENERIC, ALL CENTERS) <COMPANY LETTERHEAD> URGENT: < Insert FOOD, DRUG, MEDICAL DEVICE, BIOLOGIC, COSMETIC, etc.> RECALL <DATE> <Contact name or Dept.> <Firm Name> <Address> <City/state/zip> Dear < >: This is to inform you of a product recall involving: <Insert: PRODUCT NAME, BRAND NAME, DESCRIPTION, UPC CODES, LOT NUMBERS> See enclosed product label <for ease in identifying the product at retail/user level>. This recall has been initiated due to <problem>. Use of <or consumption of> this product may <include any potential health hazard>. We began shipping this product on <date> (or) This product was shipped to you on <date>. (If possible, provide consignee with shipping dates and quantities shipped.) Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter, or <Enclosed is a letter you should use in notifying your customers>. [Your notification must include instructions on what customers should do with the recalled product.] This recall should be carried out to the <wholesale>, <retail>, <consumer>, <user> level. Your assistance is appreciated and necessary to prevent <i.e. consumer illness or patient harm>. Please complete and return the enclosed response form as soon as possible. If you have any questions, call <name and telephone number>. This recall is being made with the knowledge of the Food and Drug Administration..Regulatory Procedures Manual March 2009 Chapter 7 Recall Procedures 7 USDA Example: SAMPLE RECALL NOTICE: May Contain GLASS, PLASTIC, ETC. [STATE] FIRM RECALLS [PRODUCT] THAT MAY CONTAIN [GLASS, PLASTIC, ETC.] [CITY], [DATE] [COMPANY], an [CITY, STATE], establishment, is recalling approximately [AMOUNT] pounds of [PRODUCT] that may contain pieces of [SPECIFY MATERIAL], [FIRM NAME]. The following products are subject to recall: [IDENTIFYING INFO: TYPE OF CONTAINER, WEIGHT, BRAND NAME AND OTHER LABEL INFORMATION, ESTABLISHMENT NUMBER, CASE AND/OR DATE CODES] The products were produced on/from [DATE] and distributed to [LEVEL OF DISTRIBUTION, i.e., RETAIL ESTABLISHMENTS, INSTITUTIONS, ETC.] in [STATES]. The problem was discovered through [SPECIFY HOW PROBLEM WAS DISCOVERED]. There have been [# or NO] reports of injury from the consumption of these products. Anyone concerned about an injury from the consumption of the products should contact a physician. Consumers with questions about the recall may contact [CONTACT TITLE AND NAME] at [TELEPHONE NUMBER]. Media with questions about the recall may contact [CONTACT TITLE AND NAME] at [TELEPHONE NUMBER]. 67

68 68

69 Responsibility to Communicate Recall 69

70 Feedback Loop quality procurement legal customers sales 70

71 Regulatory Role Federal, State, Local 71

72 Determine Lead Agency Collaborate Clarify Communicate agency s role 72

73 FDA s Role Initiation of a Recall. Classification and Strategy. Notification and Public Warning Monitoring and Auditing the Recall. Termination of Recall 73

74 State Recall Roles Lead/Coordinate Assist the federal agency (FDA or USDA) Monitor/Audit recall effectiveness Follow-up to assist industry to: Detect Correct Seize or embargo 74

75 What s MY ROLE Prevention Protection Rapid Response to Recall Investigate/ Evaluate Effectiveness of Recall/Recovery/Re-condition/Disposition 75

76 Removal of Product/Replacement Regulatory Procedures Manual, Chapter pdf Includes model recall letters, envelopes, response cards, etc Methods for Conducting Recall Effectiveness Checks, 1978 Product Recalls Including Removals and Corrections, Industry Guidance, 2003* 76

77 Fast Facts In your table groups, you have an envelope, please open your envelope and read scenario Once you have read the scenario as a team, please use your recall toolkit to respond to the situation Please present to the group, your perspective or understanding of what you are facing and outline what you need to do next. 77

78 MODULE 3 78

79 Effective Recall Strategy Planned course of action Depth of Recall Need for Public Warnings Extent of effectiveness checks for the recall * If required, HACCP system, plan in place 79

80 Recall Process Review Create a Recall Plan Problem Reported Review External Data Collect and Review Internal Data * Emergency Checklists, Analyze Evidence Recall Notification Dispose of Product Debrief, Apply for Termination of Recall 80

81 Recall Planning Post incident analysis/prevention Product Withdrawal Effectiveness Checks Crisis Public Relations (Communication) i.e., Reportable Food Register (RFR) Reduce Liability 81

82 Recall Planning Risk Assessment Traceability Lab Testing Knowledge of current Recall legislation Informing consumers and local authorities Recall log 82

83 Creating a Recall Plan 83

84 You need a RECALL PLAN Identify a Recall Coordinator Develop a Recall Team (if feasible) Establish Recall Procedures Evaluation of Health Hazards Determine the Scope of Recall Establish a system for product coding (record keeping) Implement recall communication * We will use Recall Planning Materials in Toolkit for Recall Plan activity 84

85 Recall Team Basics Coordinator Public Relations Liaison/Attorney Operations/Marketing & Sales Quality Assurance Logistics Finance/Accountant Scientific Advisor 85

86 Decision Tree Model 86

87 Decision Tree or List for Determining Product Emergencies 1. Should there be a recall in the first place? Actual or Potential for Ilness or injury? Yes INFORMATION NEEDED + An explanation of the process or findings that linked this product to particular problems or illnesses. + A specific time period for the records they are requesting. + A minimal number of individuals or agencies requesting the same information from you. + Access to supervisors or managers of the agency if a field investigator cannot answer your questions. + Copies of paperwork, from news releases to the agency s inspections, lab reports, etc. 87

88 Decision Tree or List for Determining Product Emergencies Other Action Is there a recommendation to initiate a recall? Other Action? Recall Notify Recall Team Initiate Recall Plan Classify Recall Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Correction Product or market withdrawal Stock recovery Commodity Hold and Release (USDA Only) 88

89 Decision Tree or List for Determining Product Emergencies 2. What should be recalled? INFORMATION NEEDED + Particular lots or batches. + Items made between certain production dates. + Items made at a certain plant. + Items that contain a certain ingredient, often an allergen. + Products that have been mislabeled. + Items with faulty packaging. + Products that may be contaminated. 89

90 Depth of a Recall Wholesale level HRI level Retail level Consumer level 90

91 Reporting a Recall An FDA firm that recalls should immediately notify the appropriate FDA office. 21 CFR Part 107, Subpart E Infant Formula Recalls, recalls of adulterated or misbranded infant formula that presents a risk to human health, must be reported to the FDA and the recall must be conducted in the manner specified in this part. 91

92 How & What Do I Report? Guidance for Industry: Product Recalls, Including removals and correction. FDA Guidance 11/03 (see toolkit) Info needed includes: Product (identity, size, and type of containers, brand names, lot numbers, whether refrigerated/frozen/shelf stable) Lot codes Amount and dates manufactured and distributed 92

93 What Do I Report, cont d? Number of and types of consignees, new releases to the media and any information disseminated to the public and/or consumers. Reason for recall Consignee list Actual labels or clear photos of labels 93

94 94

95 Food Registry 95

96 Let s Develop a Plan 96

97 Instructions: Please use separate recall simulation packet/hand out. Read your scenario and determine appropriate steps to conduct an effective recall, using the four objectives as outlined in your guidance. 97

98 Recall Guidance Develop & Implement Recall Plans Effectively Handle Recall Events Understand your Role and Applicable Laws/Regulations Identifying and Evaluate Hazards Effectively Manage Recall Documentation Evaluate Effective Communication Strategies 98

99 Recall Simulation 99

100 Food Recall Statistics 100

101 RECALL IMPACT IN NUMBERS 316 RECALLS IN FIRST QTR % were CLASS I EVENTS 55% were CLASS II EVENTS 9% were CLASS III EVENTS 133 companies represented 49 of them faced more than (1) recall 1 single company had 51 events 208 affected customers 101

102 What is Effective Food Recall Management? Effective coordination of stakeholders in a crisis management event- to investigate, evaluate, coordinate and implement corrective action or removal of contaminated, adulterated, misbranded food products. 102

103 Stakeholder Engagement Brian McCurtis, Stakeholder Guide (SG) 103

104 Consumer Industry Food Recall Partners Control Prevent Local/ National Manufacturers Distributors Retailers DCP DHHS/CDC/DPH FDA/OE/DCMO USDA (FSIS) DHS FOREIGN IMPORT/EXPORT Investigate Detect 104

105 What do I DO? Understand your role in food safety recalls Know your food recall partners Register with the FDA (as required under section 415(a) of the FD&C Act./ USDA (meat & poultry) Understand what a reportable food is. Know your reporting requirements (ex. Reporting Food Registry (RFR), now Safety Portal. Establish or Enhance Food Safety Management System 105

106 Consumer Industry Food Recall (Supply Chain) Partners Control Prevent DISTRIBUTOR MANUFACTURER * Processor RETAILER FOOD/FEED PRODUCER Investigate Detect 106

107 Improving Recall Management Practices PREVENTION INTERVENTION RESPONSE 107

108 Effective Recall Management Stakeholders Communication Plan Recall Plan Development Clarify and understand role of: Industry Regulatory agencies 108

109 FDA s Model effect Food Recalls P- PREVENTION An effective corporate-wide food safety and quality monitoring program I- INTERVENTION Automated and integrated technology should be developed within supply chain systems from raw materials to final products R- RESPONSE Clear roles and responsibilities should be defined in collaboration with specific stakeholders across the value chain 109

110 Federal/State Websites DCP Website USDA Website FDA 110

111 Defining & Communicating Accountability ABOVE THE LINE OF ACCOUNTABILITY BELOW THE LINE OF ACCOUNTABILITY 111

112 Tips for Improving Recall Effectiveness Use of integrated technology systems The ability to communicate potential issues on near real-time basis (i.e., Dashboard) Inform & involve procurement and supplier quality functions Gathering and using information that comes from other value chain collaborators Data predictions 112

113 Industry Guidance Links htm ce/default.htm 113

114 Tools & Resources CPSC Link - Manufacturing/Recall-Guidance/ (USDA certification) FSMA Implementation Status: FSMA@fda.hhs.gov Rule Making Process: 114

115 Other Links Partnership for Food Safety Education (PFSE) /FAQ%20&%20Recall%20Terms_FNL.pdf ucm htm 115

116 FDA Contacts Susan Liner & Pamela Ogonowski Recall Coordinators One Montvale Avenue, 4 th Floor Stoneham, MA Phone: (S. Liner) Phone: (P. Ogonowski) Fax: newenglandrecalls@fda.hhs.gov 116

117 New York District: NY Maria Caride & LCDR Melinda Ruiz Recall Coordinators Liberty Avenue 4th Floor, Room 4013 Jamaica, NY Phone: (Ms. Caride) Phone: (LCDR Ruiz) Fax:

118 State HAACP Coordinator Diane Wright Hirsch, MPH, RD (Contact) Cooperative Extension Educator/Food Safety University of Connecticut Cooperative Extension 305 Skiff Street North Haven, CT Phone: (203) Fax: (203)

119 APPENDICES 119

120 Food Recall Toolkit Overview This toolkit is designed to assist food industry firms in recall planning, strategy and effective recall management. Enhancing recall procedures and ensuring safe food safety systems requires the commitment of manufacturers, consignees, federal agencies, state agencies and local public health agencies to be effective. We hope that these tools will assist you in working with your food safety partners locally, nationally and internationally. 120

121 Connecticut Department of Consumer Protection 121

122 UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS DIRECTIVE , Revision 7 9/9/13 CHAPTER I - GENERAL I. PURPOSE RECALL OF MEAT AND POULTRY PRODUCTS This directive provides the terminology, responsibilities, and public notification procedures regarding the voluntary recall of FSIS inspected meat and poultry products. II. CANCELLATION FSIS Directive , Revision 6, Recall of Meat and Poultry Products dated 10/26/10 III. REASON FOR REISSUANCE This directive is being reissued in its entirety to provide guidance regarding recall plans and to incorporate new regulations that address the following: 1. Official establishments are required to notify their local FSIS District Office (DO) personnel within 24 hours when they learn or determine that adulterated or misbranded product has entered commerce. 2. If an official establishment notifies FSIS personnel other than the DO that adulterated or misbranded product has entered commerce, those personnel are to contact the DO promptly, through supervisory channels. They are also to notify the establishment that it is still required to contact the DO directly. IV. BACKGROUND A. A recall is a firm s action to remove product from commerce to protect the public from consuming adulterated or misbranded products. Although it is a firm s decision to recall product, FSIS coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm s recall activities. FSIS also notifies the public about product recalls. B. A recall may be an alternative to FSIS detention or seizure of adulterated or misbranded products. However, a recall does not preclude FSIS from taking other appropriate actions, such as issuing Public Health Alerts or performing product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that a firm s recall strategy or execution of that strategy is ineffective. Based on its findings, FSIS may seek enforcement action against the recalling firm or its consignees. 122

123 C. For recalls conducted by State-inspected firms or retail establishments, the appropriate State agency verifies the recall, in most cases. If requested to do so, FSIS will provide the State agencies with appropriate assistance and information. NOTE: Recall procedures for meat and poultry products produced in an establishment operating under the Cooperative Interstate Shipment program are addressed in FSIS Directive , Cooperative Interstate Shipment Program. D. When FSIS finds that imported product should be recalled, the Agency will request that the importer of record recall the product. The importer of record would be responsible for recovering the product involved and properly disposing of the affected product. V. TERMINOLOGY Recall: A firm s removal of distributed meat or poultry products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of the FMIA or the PPIA. "Recall" does not include a market withdrawal or a stock recovery. Market Withdrawal: A firm's removal or correction, on its own initiative, of a distributed product that involves a minor company quality program or regulatory program infraction that would not result in the product being adulterated or misbranded. For example, product does not meet company quality standards because of discoloration. Stock Recovery: A firm's removal or correction of product that has not been marketed or that has not left the direct control of the firm. For example, product is located on the premises owned by the producing firm or under its control. Recall Classifications: FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for recall, whether firm-initiated or requested by FSIS, and classifies the concern as one of the following: 1. Class I: This is a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Examples of a Class I recall include the presence of pathogens in ready-to-eat meat or poultry products, or the presence of E. coli O157:H7 or non-o157 Shiga toxin-producing E. coli (STECs) in raw ground beef. 2. Class II: This is a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product. An example of a Class II recall is a recall because of the presence in a product of very small amounts of undeclared allergens typically associated with milder human reactions, e.g., wheat. 3. Class III: This is a situation where the use of the product will not cause adverse health consequences. An example of a Class III recall is the presence of undeclared, generally recognized as safe, nonallergenic substances, such as excess water in meat or poultry products. Depth of Recall: The level of product distribution to which the recall is to extend: 1. Wholesale level: The product has been distributed to a warehouse or distribution center where it is not under the direct control of the producing company. This is the distribution level between the manufacturer and the retailer. This level may not be encountered in every recall situation (i.e., the recalling firm may sell directly to the retail or consumer level.) 2. Retail level: The product has been received by retailers for sale to household consumers. 3. HRI level: The product has been received by hotels, restaurants, and other institutional customers 123

124 4. Consumer level: The product has been sold directly to household consumers. Scope: This defines the amount and type of product in question. Several factors are used in determining the scope of a recall, such as the plant s processing and sanitation procedures, the definition of a lot, or specific grouping, and whether there is any finished product reincorporated into fresh product (rework). The findings of epidemiological investigations that link certain lots of product with known cases of foodborne illnesses may also affect the scope of a recall. Disposition: This is the firm's action with respect to the recalled product to correct the situation leading to the recall, such as relabeling, cooking, reworking, or destroying product. Health Hazard Evaluation Board (HHEB): The HHEB is the primary group in FSIS that reviews the public health significance of any human health hazard about which a regulatory decision needs to be made. If the risk to the public health presented by a given product appears to be unique or in some way unusual, the Recall Committee may consult the Office of Public Health Science s (OPHS) HHEB. (See FSIS Directive , Procedures for the FSIS Health Hazard Evaluation Board.) Recall Committee: A committee of representatives from various FSIS offices and staffs assembled to respond to potential or real health hazard incidents reported to the Recall Management and Technical Analysis Staff (RMTAS). 124

125 FSIS Directive Rev. 7 ATTACHMENT 3 PRODUCT RECALL GUIDELINES FOR FIRMS TABLE OF CONTENTS 1. Guiding Principles for Recall Plans 2. Notifying FSIS of Recalls 3. Recall Assessment 4. Recall Termination 5. Recall Follow-up 1. Guiding Principles for Recall Plans Introduction A recall is an effective method of removing product that may be adulterated or misbranded from commerce. Firms, including manufacturers, distributors, or importers of record, take these actions as part of their responsibility to protect the public health and welfare. A recall is voluntary, and the firm takes responsibility for the decision to recall product. FSIS coordinates with the firm to ensure that it has properly identified and removed recalled product from commerce by verifying the effectiveness of recall activities. FSIS also notifies the public about product recalls. A recall may be an alternative to FSIS detention or seizure of adulterated or misbranded products. However, a recall does not preclude FSIS from taking other appropriate actions, such as issuing Public Health Alerts or performing product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that the recall strategy or execution of that strategy is ineffective. Based on its findings, FSIS may seek enforcement action against the firm or its consignees. A recall can occur for many different reasons. Typically, the reason for the recall is not discovered until the product is already in distribution channels. Ways a firm may learn about the problem include through FSIS, the firm s customers, consumer complaints, or its own review of company or laboratory documents. When an official establishment believes or has reason to believe that adulterated or misbranded product has been shipped into commerce, it must inform its district office (DO) of the type, amount, origin, and destination of the product. Early detection and recognition that a problem may exist is essential to a successful recall action. A recall can be disruptive to a firm's operation and business; however, there are several steps that can be taken to minimize this disruption. An operator of an inspected establishment should take measures that will ensure rapid and effective response if products that appear to be adulterated have entered commerce. Official establishments are required to have recall plans that describe the actions they will take to recall adulterated or misbranded products that are in commerce, as provided by 9 CFR A recall plan must consist of written procedures that specify how the official establishment will decide whether to conduct a product recall and how it will affect the recall, should it decide that one is necessary. 125

126 Recall Plan The guidance presented here is intended for all meat and poultry firms that may need to conduct a recall, without regard to plant size or the number of people employed. Some of the recommendations may speak in terms of forming teams of employees to conduct certain activities related to recalls or may seem to imply that sophisticated analyses of potential health hazard situations need to be conducted. However, the key activities discussed below can be performed by one (1) or two (2) individuals in circumstances where there are limited resources. For example, in a small plant operation, the owner or manager of the establishment may be the recall coordinator as well as the contact for the Agency, the firm s consignees, and the public. The Agency does not expect smaller establishments to hire personnel simply to prepare for recalls. On the contrary, the Agency strongly encourages the management of all firms to prepare themselves, and their regularly employed personnel, for the potential of having to conduct a recall. FSIS regulations require official establishments that produce meat and poultry products to prepare and maintain written recall plans. The plan must specify how the firm will decide whether to conduct a product recall, and describe, step-by-step, the procedures to follow if a product recall is necessary. In addition, FSIS requires that the recall plan be available for review upon request. The following is a list of factors to consider when formulating an effective recall plan. A. Recall Team Members. One person should be identified as the recall coordinator. The recall coordinator should be authorized to make decisions regarding recall implementation. This person is responsible for managing and coordinating all recall-related activities. The Recall Coordinator will have access to the recall plan and should be knowledgeable about the firm s operations, including purchasing, processing, quality assurance, distribution, and consumer complaints. The recall coordinator should select people to form a recall team. In establishments with only a few employees, one person can have multiple roles. There is no need to hire additional personnel to execute a recall plan. For each internal and external member involved in the recall action, contact information (telephone, facsimile numbers, and addresses, as appropriate) should be identified. In the event that the primary team member is absent, an alternate should be specified. All contact information should be reviewed regularly for accuracy. The roles and responsibilities of every person should be clearly defined. A firm s recall plan should include the telephone number of its FSIS DO. B. Procedures for Determining Whether a Recall is Necessary. The recall plan should specify, in detail, actions that the firm will take. All information should be reviewed in determining whether to implement a recall. Factors to consider include: 1) Has adulterated or misbranded product been produced? 2) Has adulterated or misbranded product been shipped? 3) Where has the product been shipped? 4) Is the product in commerce? 5) Is the product available to consumers? Note: If adulterated or misbranded product is in commerce, the firm must notify the applicable FSIS DO within 24 hours. FSIS will then determine the class of the recall based on the potential health risk. 126

127 C. Scope of Recall. The plan should outline how the establishment will assess the amount and kind of product that is implicated in a problem. It is the firm s responsibility to define when the problem began, when it was resolved, and what products are affected. As much of this information as possible should be available when the FSIS DO is contacted. FSIS suggests that the plan specify how the amount of product affected under various scenarios will be determined. Some examples of how to define the scope of product removal actions include: the contamination of a vat of product with a foreign object, the use of an incorrect label, or the use of the same source of raw materials in other lots on other days of production. FSIS will consider such factors as the establishment s coding of product; the pathogen of concern; processing and packaging operations; equipment; the establishment s HACCP plan monitoring and verification activities (including microbiological testing); the establishment s Sanitation SOP records; and whether some or all of the products controlled by the same or substantially similar HACCP plans have been affected. Clean up times do not necessarily define the scope of a recall. It is to the firm s benefit to identify correctly the scope of the recall. If the recall needs to be expanded, additional FSIS Recall Releases may be issued, resulting in further media postings. If the firm cannot be certain of the amount of product affected, it is better to be more inclusive in the estimate than to risk an expansion. Good recordkeeping is often the easiest way to maintain accuracy. D. Records. All firms should use a system of product coding sufficient to permit positive product identification and to facilitate effective recalls. Records should be maintained for a period of time that exceeds the shelf life and expected use of the product and at least the length of time specified in FSIS regulations concerning record retention (9 CFR 320; ). Records are vital in tracing product forward to consignees and back to potential suppliers. They include invoices, bills of sale, and shipping documents. Records a firm should have on hand include: 1) Records for positive identification of products produced (labels, lot numbers, Julian codes, ), and 2) Distribution information for recalled products. These records may include names/addresses of consignees, method of shipment, date of shipment. It is also useful to note consignees that are schools, hospitals, and distributors. Firms should maintain production records that would facilitate the traceback of product ingredients. This will help determine causes of adulteration and define the scope of recalls. In the event a recall is necessary because of a positive result on an Agency sample or an outbreak of foodborne illness, verifiable records may be used to demonstrate limiting factors to narrow the scope of a recall. Moreover, the records would be essential in facilitating the traceback of the contamination to its source. Regarding Escherichia coli O157:H7 and non-o157 STECS, establishments are expected to maintain supplier records for their raw ground beef components and to make these records available to Agency personnel upon request. Then, if a sample of raw ground beef is reported positive, suppliers may be notified that their product may have been the source of contamination. The information FSIS personnel collect includes the name of the supplying establishment, the supplier s lot number, and production date of the product. This information has proven to be an effective tool for initiating traceback in an effort to find the source of contamination. 127

128 If a recall is necessary, a prudent establishment may be able to limit the amount of affected product if it has a detailed record keeping system in place. Carefully maintained production records can serve a vital public health purpose. They provide the establishment and the Agency with a means of pinpointing potential sources of contamination and allow for greater accuracy in deciding which products may be affected. The kinds of records comprising such a system include production or grinding logs showing the times of each grind; the formulation or blend of raw ingredients including amounts and supplier lot identification; the finished product lot and sublot identification; and any microbial data or other information that may indicate microbial independence. The records should indicate and track which lots or sublots of a grinding establishment s ground beef or other raw materials were used. The records should also track the amounts of each that were used. 128

129 Here s a practical example. If a recall of raw ground beef products is necessary because of contamination with E. coli O157:H7, a key factor in limiting the scope of the recall would be if the establishment (or retail store) is cleaning the grinding equipment between lots. If not, there could be residue contamination from one lot to another. A grinding log indicating lot numbers, supplier, and clean up times, may help limit the scope of the recall. Having these records be clear and easily available will also help the recall process to occur more smoothly. E. Recall Communications. Firms should issue a recall notice to consignees by , telephone, letter, or fax. Written notices should bear a prominent heading to indicate the importance of the communication. For example, a letter might bear a bold red declaration, URGENT FOOD RECALL. If communication is conducted by phone, it should be followed with a letter, , or fax. When drafting your recall notice to your direct consignees, consider the following: 1) Be brief and direct; 2) Explain the reason for the recall and the associated hazard; 3) Clearly describe the product and provide sufficient information to enable the accurate and immediate identification of the product including: product/brand name product code package/case size package/case date code lot number/expiration date UPC code; 4) Provide an explanation of the risk involved if product is used; 5) Request an official, written response from the consignee firm. Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product. Consider allowing the recipient to place a collect call to the recalling firm; 6) Provide instructions on what to do with the recalled products. Those instructions can include anything from destruction at the consignee location to return to the official plant; and 7) Provide plant contact information (for questions). The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. F. Public Notification. Identify if and how the public will be notified of the recall. Recalls are often announced via a press release through national or local news media or via a company website. Include contact information for all potential media outlets, such as television stations, radio stations, and newspapers, and with local, state, and regional coverage areas, as well as the national wire services. The class of a recall and the extent to which the product was distributed in commerce (wholesale, retail, or hotel/restaurant/institutional (HRI)) will determine the distribution of public notification. 129

130 FDA SAMPLE FOR IMMEDIATE RELEASE COMPANY CONTACT AND PHONE NUMBER DATE FOOD CO. ISSUES ALLERGY ALERT ON UNDECLARED (ALLERGEN) IN PRODUCT Company Name of City, State is recalling Quantity and/or type of Product, because it may contain undeclared specific type of allergen. People who have an allergy or severe sensitivity to specific type of allergen (e.g., peanuts, tree nuts {chestnuts, brazil nuts, walnuts, hazelnuts, pecans, pine nuts, cashews}, eggs, and sulfites) run the risk of serious or life-threatening allergic reaction if they consume these products. Product was distributed Listing of the states and areas where the product was distributed and how it reached consumers (e.g., through retail stores, mail order, direct delivery). Specific information on how the product can be identified (e.g., type of container [plastic/glass/metal] size or appearance of product, product brand name, flavor, codes, expiration dates, etc.). Status of the number of and types of related illnesses that have been CONFIRMED to date (e.g., "No illnesses have been reported to date.") Brief explanation about what is known about the problem, such as how it was revealed, and what is known about its source. An example of such a description -- "the recall was initiated after it was discovered that product containing (the allergen) was distributed in packaging that did not reveal the presence of (the allergen). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes." Information on what consumers should do with the product and where they can get additional information (e.g., "consumers who have purchased Brand X are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at XXX-XXXX.) #### 130

131 (SAMPLE FDA PRESS RELEASE) XYZ Inc. 123 Smith Lane Anywhere, MS FOR IMMEDIATE RELEASE Sam Smith / DATE XYZ ISSUES ALLERGY ALERT ON UNDECLARED PEANUTS IN "SNACKIES" XYZ Inc. of Anywhere, MS, is recalling its 5 ounce packages of "Snackies" food treats because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled "Snackies" were distributed nationwide in retail stores and through mail orders. The product comes in a 5 ounce, clear plastic package marked with lot # on the top and with an expiration date of 12/12/99 stamped on the side. No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the peanut-containing product was distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes. Production of the product has been suspended until FDA and the company are certain that the problem has been corrected. Consumers who have purchased 5 ounce packages of "Snackies" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at XXX-XXXX. #### - 131

132 Notes 132

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