REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
1. Capsicum pods (includes all capsicums; chili peppers, paprika, etc.), when analyzed using MPM V.8.A (Page V-32): a. If the capsicum contains an average of more than 3% insect infested and/or moldy pods by weight;
b. If the capsicum contains an average of more than 1 milligram of mammalian excreta per pound (mammalian excreta should be identified as to source when possible).
2. Ground capsicums (cayenne, red pepper, etc.), excluding paprika: a. If the average mold count is more than 20% when analyzed using AOAC 915.94, 15th Ed.;
b. If the capsicum powder contains an average of more than 50 insect fragments per 25 grams or an average of more than 6 rodent hairs per 25 grams using AOAC 978.22, 15th Ed.
3. Ground paprika: a. If the average mold count is more than 20% when analyzed using AOAC 915.94, 15th Ed.;
b. If the ground paprika contains an average of more than 75 insect fragments per 25 grams, or an average of more than 11 rodent hairs per 25 grams, when analyzed using 977.25B, 15th Ed.
Since the majority of spices are imported, determine that the lot in question has not been previously examined and released by FDA as an import. If the lot has been examined and released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for seizure consideration in the usual manner.
Article (capsicum pods/ground capsicums/ground paprika) adulterated (when introduced into and while in interstate commerce)(while held for sale after shipment in interstate commerce), within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of presence therein of (insects), (insect webbing), (insect excreta), (insect fragments), (insect damaged capsicum pods/ground capsicums/ground paprika), and (mammalian excreta) (rodent hairs); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed capsicum pods/ground capsicums/ground paprika).
*Material between asterisks is new or revised.*
Revised: 3/95, 5/05
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.