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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