REGULATORY ACTION GUIDANCE:
The following represents 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 from the appropriate Field Office within the Human and Animal Food Program*:
1. The cocoa beans contain an average of more than 4 percent moldy beans by count;
2. The cocoa beans contain an average of more than 4 percent insect infested or insect damaged beans, by count; or
3. The cocoa beans contain an average of more than 6 percent reject beans (moldy plus insect infested or insect damaged beans) by count.
If live external infestation is present use the CPG "Food Storage and Warehousing - Adulteration - Filth" (See Sec. 580.100 for CPG 7103.01).
Article (cocoa beans) 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 there in of (insects) (insect fragments) (insect damaged cocoa beans); and that it consists in part of a decomposed substance by reason of the presence therein of (moldy, decomposed cocoa beans).
CRITERIA FOR RECOMMENDING LEGAL ACTION:
The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The cocoa beans contain an average of 10 mgs or more mammalian excreta per pound.
NOTE: Analyses for mold, insect damage, and mammalian excreta are conducted using the method specified in FDA Technical Bulletin 5, Macroanalytical Procedures Manual, Chapter V.4.A - Method for Cocoa Beans.
*Material between asterisks is new or revised.*
Revised: 3/95, 8/96, 5/05
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.