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*:
A minimum of six subsamples is required for examination.
1. Mold: The apple butter has an average mold count of 12% or more;
2. Rodent Filth: The apple butter contains an average of 4 or more rodent hairs per 100 grams;
3. Insects: The apple butter contains an average of 5 or more whole or equivalent insects (not counting mites, aphids, thrips or scale insects) per 100 grams.
Seizures of canned apple butter must be discussed with the U.S. Department of Agriculture. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Date of Shipment
Amount of Lot
Article adulterated when introduced into and while in interstate commerce, within the 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 and rodent hairs; and of a decomposed substance by reason of presence therein of decomposed apple butter.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005 Updated: 11/29/05
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.