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*:
NOTE: Examine a minimum of 10 subs from each code or from the lot if no codes are present.
MOLD: Natural raisins average 5 percent or more by count moldy.
SAND: The average is 40 milligrams or more of sand and grit per 100 grams of natural or Golden Bleached raisins.
INSECTS: The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
Golden Bleached raisins contain an average of 10 or more whole insects or equivalent and 35 Drosophila eggs per 8 ounces.
Seizure of this product 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:
Amount of Lot
Date of Shipment
MOLD: Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3) in that it consists wholly or in part of a decomposed substance by reason of presence therein of moldy, decomposed raisins.
SAND AND GRIT: Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3) in that it is unfit for food by reason of presence therein of sand and grit.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005
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.