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

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

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

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

Food Allergen Partnership Inspectional Findings

Food Allergen Partnership Firms Inspected that Verified Labels by Commodity

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.

Inspectional Findings Advisory Labeling

Food Allergen Partnership Firms Inspected that Utilize Rework by Commodity

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

Food Allergen Partnership Procedures to Prevent Cross-Contact by Commodity

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

Food Allergen Partnership Sampling & Analysis

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

Food Allergen Partnership Analytical Findings - Peanut Sample Results

Food Allergen Partnership Inspectional Findings - The Total Picture

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

Food Allergen Partnership Follow-up Activities

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

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

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