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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 525.350 Fennel Seed - Adulteration by Mammalian Excreta; Insects November 2005

Final
Issued by:
Guidance Issuing Office
Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition

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. Insects and Mammalian Excreta:

The fennel seed in 20% or more of the subsamples contain mammalian excreta and/or insects;

or

2. Mammalian Excreta:

The fennel seed contains an average of 3 milligrams or more of mammalian excreta per pound.

REMARKS:

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.

SPECIMEN CHARGE:

Article fennel seed 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 damaged fennel seed) and (mammalian excreta).

*Materials between asterisks are new or revised*

Issued: 10/1/80
Revised: 3/95, 5/05
Updated: 11/29/05


Submit Comments

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:

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