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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sample Schedule 13: ALLERGEN SAMPLE

SAMPLE SIZES WITH APPLICATION TO FOOD PRODUCTS FOR ALLERGENSa

(Listed below is the sample size needed for lab analysis.  Collect all samples in duplicate, with the duplicate serving as the 702 (b) reserve sample)

ProductPackage
type
Number of
sample units
Unit sizeTotal sample
Non-liquefied foods, i.e., cereals, cookiesConsumer201 lb20 lbs
Pre-liquefied foods, i.e., ice cream, chocolatesConsumer101 lb10 lbs
Paste or slurry typeConsumer24
12
8 oz
1 lb
12 lbs
12 lbs
Fluid, i.e., beveragesConsumer1016 fl. oz160 fl. oz

IMPORTANT!  WHEN TO SAMPLE: At the time of submission of this table to the IOM, only “for cause” allergen samples for peanut contamination should be collected.  Test methods for additional allergens are under development and the field will be notified when they are available for regulatory purposes.  The allergen compliance program, when issued, will provide additional sampling guidance. “For cause” sampling should be limited to instances where a consumer, medically determined to have a food allergy, experiences an adverse event believed due to the allergenic food, and the labeling of the suspect product does not indicate the presence of the allergen.

a See Laboratory Information Bulletin (LIB) # 4341, Application of Validated, Multiple Laboratory Performance Test MethodsSM for the Detection of Peanuts in Food, Vol 21(2) 2005 for details regarding the analysis and quantitation of analytical samples.

Note: To be collected from random sites. May combine subs or maintain sub integrity depending on purpose of sampling

Note: Prepare composite following proper grinding and mixing procedures. Separate four 1-lb portions from composite.

Adapted from U.S. Food and Drug Administration, Office of Regulatory Affairs, Investigations Operations Manual, Chapter 4, Sample Schedule 6, Mycotoxin Sample Sizes