Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis...

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Summary of Inspectional Findings

Food Allergen Partnership 1999 - 2000Theresa 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

• 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

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

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

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

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

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

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

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 protein40 bakeries, 10 ice cream, 23 candy

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

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

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

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

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

We Are All In This Together

Labeling is a Food Safety Concern