The Pillars of Allergen Recall Prevention

Human error is a frequent cause of allergen-related recalls in food manufacturing, often happening when management systems are not designed to prevent errors.

Preventing an allergen recall requires an understanding of production processes, a focus on consistency, and effective communication with upper management. In this presentation, we’ll focus on what tools and practices are needed to prevent costly allergen-related recalls including:

• Awareness of the broad financial implications of an allergen-related recall
• How to align with upper management on allergen control measures
• Bridging allergen control processes with quality control to ensure consistency and compliance

1. Dr. Steven Gendel Sr. Advisor, Food Safety The Pillars of Allergen Recall Prevention

2. A global food safety and public health consulting group made up of seasoned industry experts Award-winning digital plant management platform to visualize plant-wide performance and better control quality, yield & production optimization. Brought to you by:

3. Meet Your FSMA Friday Speaker Dr. Steven Gendel Sr. Advisor, Food Safety Dr. Gendel’s experience includes over two decades of working on science and policy in the FDA Center for Food Safety and Applied Nutrition (CFSAN). He was the first FDA Food Allergen Coordinator, and contributed to the Preventive Controls for Human Foods Rule, the Gluten-Free Labeling Rule, and multiple agency documents. He also provided support to FDA inspection and enforcement programs. He is an internationally recognized expert on safety assessments for novel food proteins.

4. FSMA: Regulatory Updates Recent FDA Reorganization

5. Allergen Recalls : You've heard about the problem

6. Allergen Recalls : You’ve heard about the cost It is a lot more than you can afford… Direct costs Indirect costs Non-monetary impacts

7. Regulatory Risk 21 CFR 117 requires that you: “protect against allergen cross-contact” “(i) Ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and (ii) Labeling the finished food, including ensuring that the finished food is not misbranded” By:

8. How can you avoid allergen recalls? The three pillars of effective allergen management: Know what you make Watch what you say Control what you do 1 2 3

9. Know what you make Watch what you say Control what you do 1 2 3 How can you avoid allergen recalls? The three pillars of effective allergen management: Intended allergens Intended & unintended allergens

10. Know what you make Formulas/Recipes Has anything changed? Don’t add new allergens if that can be avoided Control ingredients during production 1

11. Watch what you say Label designs Label controls Is the current label design accurate & complete? If you use outside printing – check what you get If you print in-house – double-check templates, files, and controls Match products and packages 2

12. Control what you do Supplier controls Cross-contact controls Cleaning Is your supplier info up-to-date and accurate? Cross-contact control = separation in time and/or space Cleaning means removing protein residues 3

13. Documents and Records No credit if you can’t show your work “Our packaging machine is cleaned properly however our written documentation did not clearly state that.”

14. Special topics in allergen control Advisory labels Testing and analysis

15. How do you convince others that allergen control is worth doing well ? You already do most of it in Quality Control: Use vetted suppliers Use raw materials that meet specifications Manufacture according to your recipes Put products in the right containers Don’t make a mess & clean up

16. How do you convince others that allergen control is worth doing well ? Every recall is in your “permanent record”

17. How do you convince others that allergen control is worth doing well ? Show what a recall would cost: Use scenarios (Finance and marketing call this forecasting) You start this when you test the effectiveness of your recall plan Learn from other’s recalls

18. The Pillars of Allergen Recall Prevention There is a fourth pillar … Asking for help 4

19. Dr. Steven Gendel Sr. Advisor, Food Safety The Pillars of Allergen Recall Prevention

20. Allergen Control & Recall Prevention [email protected] https://www.linkedin.com/in/stevenmgendel/ Steven Gendel Gendel Food Safety LLC Help is available; just ask: