2. Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

3. Food Allergen Partnership Establishments Inspected Minnesota 41 Inspections Planned 40 Inspections done (1 bakery firm OOB) 31 Bakery 3 Ice Cream 6 Candy Wisconsin 45 Inspections Planned & conducted 23 bakery 10 ice cream 12 candy

4. Establishment Size Based on Annual Gross Sales Small 1: $ 25,000 - $ 49,999 2: $ 50,000 - $ 99,999 3: $100,000 - $499,999 Medium 4: $500,000 - $999,999 5: $1,000,000 - $4,999,999 6: $5,000,000 - $9,999,999 Large 7: $10,000,000 - $24,999,999 8: $25,000,000 - $49,999,999 9: $50,000,000 and over

5. Food Allergen Partnership Key Inspection Focus Areas Raw Ingredients & Formulations –Compared ingredients with labels Processing & Production Schedules – Observed potential for cross-contact Sanitation –Observed cleaning “allergen clean” Observed rework procedures Employee Practices & Education Packaging & Labeling –Obtained labels Recall procedures & Obtained samples

6. Food Allergen Partnership Inspectional Findings

7. Food Allergen Partnership Firms Inspected that Verified Labels by Commodity

8. Food Allergen Partnership Inspectional Findings - Label Verification 45 Firms felt that they had adequate procedures to verify label accuracy; However, 15% had incorrect finished product labels. Of the firms that did not verify label accuracy; 51% had incorrect finished product labels.

9. Inspectional Findings Advisory Labeling

10. Food Allergen Partnership Firms Inspected that Utilize Rework by Commodity

11. Food Allergen Partnership Summary of Findings - Rework Of the firms that utilized rework, 48 % of had product that tested positive for undeclared allergen residues.

12. Food Allergen Partnership Procedures to Prevent Cross-Contact by Commodity

13. Food Allergen Partnership Summary of Findings – Cross-Contact Scheduling –“First-in / First-out” –Product Color Non-dedicated equipment Inadequately cleaning –Water only –Reused without cleaning

14. Food Allergen Partnership Sampling & Analysis

15. Food Allergen Partnership 118 Partnership Samples 73 Samples for peanut protein 40 bakeries, 10 ice cream, 23 candy 45 Samples for egg protein 34 bakeries, 6 ice cream, 5 candy

16. Food Allergen Partnership Analytical Findings - Peanut Sample Results

17. Food Allergen Partnership Inspectional Findings - The Total Picture

18. Food Allergen Partnership Partnership Workshops - Industry Education 3 Industry workshops - Fond du Lac & Madison, WI - Minneapolis, MN Presentations on subject from many angles - Local partners- Physicians - Industry representatives - Lawyers - CFSAN - National expert Distribution of allergen educational materials

19. Food Allergen Partnership Follow-up Activities

20. Food Allergen Partnership Follow-up Inspection & Samples MinnesotaWisconsin InspectedSampledInspectedSampled Bakery7543 Ice Cream1144 Chocolate1144 Total971211

21. Food Allergen Partnership Follow-up Inspection - Firm Response Change in Standard Operating Procedures TotalMNWI Allergen Policy615 Label Verification505 Rework523 Cross-Contact945 Test Verification312

22. We Are All In This Together Labeling is a Food Safety Concern