Allergen Control Strategies - A “How To” Guide

2. Allergen Control Strategies- A “How To” Guide Hormel Foods Corporation Brent Brehmer Corporate Manager of Regulatory Compliance & HACCP

9. F/Y 2011 – Consumer Response handled > 140,000 contacts – Top questions: • 1. Where to purchase products • 2. Shelf-Life questions • 3. Coupon requests • 4. Allergen & Gluten questions

10. Actual Customer Comments/Questions • “Is Chi Chi’s Salsa gluten free?” • “Is there dairy is potassium lactate?” • “I just wanted to thank you for going the extra mile for people w/ Celiac Disease. I noticed you even put “gluten-free” on some of your labels. My 5 yr old has the disease & she loves your pepperoni. I can’t tell you how hard it is to stick to her diet & I am so thankful for companies who have regular food that is gluten-free so our whole family can eat the same foods. I can tell you that as long as you’re taking the precautions to keep them gluten-free, I will be a devoted Hormel customer…”

11. Allergen Program – What Does One Look Like? • Hormel’s • 110+ Food Safety Assessments • 30 GFSI Audits Annually • Dozens of Customer Audits

12. Allergens & HACCP • Allergens are a “Chemical” Hazard • Hazard = presence of an Unlabeled Allergen • Control Point or CCP? • Prerequisite Program • Hazard Not Likely to Occur • Ingredient Usage Page - Added “Allergen” section.

13. Added “Allergen” Category

14. Possible CCPs • Product Changeover • Labeling • Control of Rework

15. Starts at “Product Formulation” • R&D

16. Product Development Strategies • Determine allergenicity of ingredients; • Avoid allergenic ingredients which have no functional effect on the finished product • Find substitutions for allergenic ingredients! • Identify Allergens on Formulas sent to plant.

17. Hormel’s Allergen Program • “Big 10” • Big 8 + Sesame Seeds + Molluscan Shellfish • List on file: • At Corporate • In Plant • New Ingredients • HACCP Plan.

18. Incoming Ingredients – Labeling Requirements of Allergens • “Allergen” Sticker on each Pallet • 5” x 8” • Brightly Colored • Supplier Applies • If not on, • Apply at Receiving & • Notify Supplier • Easily readable on walk-throughs.

19. Storage of Ingredients • Ideal - Dedicated Room or at Least Rows • Realistic – No Allergens stored above non-allergenic product.

20. Open to contamination or able to cross-contact other products.

21. “Cross Contact” NOT “Cross Contamination”

22. Milk Item Improper Storage

23. Storage of Ingredients - Bulk • Containers Labeled • Dedicated (Color-coded) Scoops • Procedures - Employees in Spice Rooms working w/ Allergens must: • Wear Disposable outerwear (sleeves, aprons & gloves); • Change outerwear & wipe down helmet at: • Each break • When changing to other non-allergen product.

24. Product Scheduling • Huge • More important than “color” issues • Order must be: • Non-Allergen first • Allergen #1 • Allergen #1 & Allergen #2 • Etc. • Allergen Cleanup

25. Changeovers – Validation of Cleanups • 3 Separate Runs on our Production Lines • Choose Product Based On: • Highest Percentage in Product • Toughest to Clean (i.e. Burn-On) • Run Allergenic Product & Pull Control Sample • Conduct the planned “Allergen Cleanup” • Record Procedures Used (Full 4-Step Cleanup, Water Rinse, Sugar Rinse, etc.) • Run Non-Allergenic Product & Pull Samples: • First Unit, after 5 minutes, after 10 minutes

26. Changeovers – Validation of Cleanups – (continued) • Test Control Product & Changeover Product • University of Nebraska (Lincoln) – FARRP or • On-Site using approved test kits (i.e. Neogen® - pending Corp. approval) • Must choose Level • i.e. 10 ppm, 5 ppm, 2.5 ppm • HOLD ALL PRODUCT PENDING RESULTS!!!!! • Disposition • “Negative” – Release Product • “Positive” – Contact Corp. QC for disposition • Record Results on “Allergen Validation Testing Record”

27. Neogen.com

29. Rework Requirements • Label • Store Properly • Exact Into Exact • NOT Like Into Like • Record Code Dates • Implement Rework Cycle Breaks.

30. Procedures for “Suspect” Product • Place all suspect product on HOLD; • Call Brent

31. Label Verification Program

32. Incoming Labels • Pull 1 from each incoming lot - Place on Hold until: • Compare the Big 9 (Hormel Term) • Ingredient Listing • Est. # • Nutrition Facts Panel • Net Wgt • Address Line • Safe Handling Instructions (Raw items) • Product of Identity • Manufacturer ID (37600 on Bar Code Label) • SI # + Version • S0044208-24 (15 oz. CWB – 24th version)

33. Incoming Multiple-Component Ingredients • Place on Hold • Compare Ingredient Listing to Approved File.

34. Formulation Changes • Line Trial System – • New Product • Reformulation • Unique Number Assigned to Each • Hold & Release Program • If Approved • System in place to convert

35. Formulation Verification (Batching) • Record Item / SI numbers • Record Lot Numbers • In-Process Labels • Must have Ingredients listed • Verify amounts used • Restricted Ingredients • Stored under Lock & Key

36. Packaging Line Procedures • Save 1 label per Roll (or case); • Verify Big 9; • Corrugate (save 1 box / pallet); • 3 Individuals (min. of 2 mgt.) Verify

37. Ingredient / Product Spills • Cleaned in a manner as to prevent any cross-contact.

38. Packaging “Leakers” • Dispose of Properly • Properly clean line.

39. Allergen Training • Annual Training of all employees • (30 minutes) • Record

40. Obsolete Labels • Isolated • Destroyed

41. Hold Requirements • Normal Hold for “Quality” Issues • Category 1 Hold – Food Safety Issues • Pathogen Testing • Allergen Testing • “Daily Inventory” • Electronic (minimum) • Physical (when possible)

42. If score > 90 in each HACCP Sanitation Quality No Product Recalls or Market Withdrawals AND > 80 in each “Quality” Category: Foreign Material Food Defense Wgt Control Label Verification Thermal Processing Minimizing the Window Ingredient Receiving Internal Audits Conducted by Corporate – “Quality Cup”

43. Additional Site Specific Actions

44. High-Speed Packaging Lines • Red & Yellow Hormel® Chili • CNB – Soy & Wheat • CWB – Soy only • 500+ cans / min. • Bar-code reading systems • (See next slides)

45. SI #

46. Questions?