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*:
The figs contain an average of 10% or more by count insect infested and/or moldy and/or dirty fruit or pieces of fruit.
2. Fig Paste
The fig paste contains 13 or more insect heads per 100 grams of fig paste in each of 2 or more subsamples when examined by AOAC methods of analysis, 44.083(a) and (b), AOAC 12th Ed. or 44.A02 1st Suppl. 12th Ed.
Seizures involving these products 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 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 figs; dirt; and of a decomposed substance by reason of presence therein of moldy, decomposed figs.
*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.