REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:
NOTE: Examine a minimum of ten subsamples.
- Dried and Dehydrated Low Moisture Prunes - The average of the subsamples is 5 percent or more by count insect infested, moldy or decomposed, dirty and/or otherwise unfit prunes.
- Pitted Prunes - Examination of a minimum of 50 prunes from each of 10 subs from each code, or from the lot if no codes are present, by microanalytical manual method M13K3 shows the following:
An average of 2% or more by count of prunes with whole pits and/or pit fragments 2mm or longer;
Four or more of the 10 subs examined contain 2% or more prunes by count with whole pits and/or pit fragments 2 mm or longer.
Seizures of these products must be discussed with U.S.D.A. *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
- Filth adulteration - Article adulterated when introduced into and while in interstate commerce, within the meaning of 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 prunes and dirt; and of a decomposed substance by reason of presence therein of moldy, decomposed prunes.
- Pitted Prunes - Article adulterated when introduced into and while in interstate commerce, within the meaning of U.S.C. 342(b)(2) in that prunes with pits and/or pit fragments have been substituted wholly or in part for pitted prunes.
Article misbranded when introduced into and while in interstate commerce, within meaning of *21 U.S.C. 343(a)(1)* in that label statement "Pitted Prunes" is false and misleading as applied to a product containing prunes with pit fragments.
Revised: 3/95, 5/2005