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

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Page 1: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Summary of Inspectional Findings

Food Allergen Partnership 1999 - 2000Theresa C. Dziuk

Minneapolis District FDA

August 13, 2001

Page 2: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 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

Page 3: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Establishment Size Based on Annual Gross Sales

• Small1: $ 25,000 - $ 49,9992: $ 50,000 - $ 99,9993: $100,000 - $499,999

• Medium4: $500,000 - $999,9995: $1,000,000 - $4,999,9996: $5,000,000 - $9,999,999

• Large7: $10,000,000 - $24,999,9998: $25,000,000 - $49,999,9999: $50,000,000 and over

4045

85

116

1720

31

51

9 817

0

10

20

30

40

50

60

70

80

90

Minnesota Wisconsin Total

Page 4: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

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

Page 5: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership

Inspectional Findings

Page 6: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Firms Inspected that Verified Labels by Commodity

85

54

1318

45

23

814

2014

2 4

25

9 610

0

10

20

30

40

50

60

70

80

90

Total Bakery Ice Cream Chocolate

Total Firms Verify Label MN WI

Page 7: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

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.

Page 8: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Inspectional Findings

Advisory Labeling

Page 9: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Firms Inspected that Utilize Rework by Commodity

85

54

1318

37

24

49

15 13

0 2

22

114 7

0

10

20

30

40

50

60

70

80

90

Total Bakery Ice Cream Chocolate

Total Firms Rework MN WI

Page 10: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Summary of Findings - Rework

Of the firms that utilized rework,

48 % of had product that tested positive for undeclared allergen

residues.

Page 11: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Procedures to Prevent Cross-Contact by Commodity

85

54

1318

41

23

9 915

102 3

26

137 6

0

10

20

30

40

50

60

70

80

90

Total Bakery Ice Cream Chocolate

Total Firms Cross-Contact MN WI

Page 12: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

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

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

Food Allergen Partnership

Sampling & Analysis

Page 14: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership 118 Partnership Samples

73 Samples for peanut protein40 bakeries, 10 ice cream, 23 candy

45 Samples for egg protein34 bakeries, 6 ice cream, 5 candy

Page 15: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Analytical Findings - Peanut Sample Results

73

40

10

2318

11

169 7

1 19

1 05

0

10

20

30

40

50

60

70

80

Total Bakery Ice Cream Chocolate

Samples Obtained Positive Peanut MN Positive WI Positive

Page 16: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership

Inspectional Findings - The Total Picture

Page 17: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

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

Page 18: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership

Follow-up Activities

Page 19: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Follow-up Inspection & Samples

Minnesota Wisconsin

Inspected Sampled Inspected Sampled

Bakery 7 5 4 3

Ice Cream 1 1 4 4

Chocolate 1 1 4 4

Total 9 7 12 11

Page 20: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Food Allergen Partnership Follow-up Inspection - Firm Response

Change in Standard Operating Procedures

Total MN WI

Allergen Policy 6 1 5

Label Verification 5 0 5

Rework 5 2 3

Cross-Contact 9 4 5

Test Verification 3 1 2

Page 21: Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

We Are All In This Together

Labeling is a Food Safety Concern