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Summary of Inspectional Findings. Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001. Minnesota 41 Inspections Planned 40 Inspections done (1 bakery firm OOB) 31 Bakery 3 Ice Cream 6 Candy. Wisconsin 45 Inspections Planned & conducted

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Summary of Inspectional Findings

Food Allergen Partnership1999 - 2000

Theresa C. Dziuk

Minneapolis District FDA

August 13, 2001


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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

Food Allergen Partnership Establishments Inspected


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Establishment SizeBased 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


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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


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Food Allergen Partnership

Inspectional Findings


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Food Allergen PartnershipFirms Inspected that Verified Labels by Commodity


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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.


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Inspectional Findings

Advisory Labeling


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Food Allergen Partnership Firms Inspected that Utilize Rework by Commodity


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Food Allergen Partnership Summary of Findings - Rework

Of the firms that utilized rework,

48 % of had product that tested positive for undeclared allergen residues.


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Food Allergen Partnership Procedures to Prevent Cross-Contact by Commodity


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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


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Food Allergen Partnership

Sampling & Analysis


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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


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Food Allergen PartnershipAnalytical Findings - Peanut Sample Results


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Food Allergen Partnership

Inspectional Findings - The Total Picture


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Food Allergen PartnershipPartnership 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


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Food Allergen Partnership

Follow-up Activities


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Food Allergen Partnership Follow-up Inspection & Samples


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Food Allergen Partnership Follow-up Inspection - Firm Response


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We Are All In This Together

Labeling is a Food Safety Concern


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