REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to *the Office of General Counsel* through Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:
- The cocoa beans contain an average of more than 4 percent moldy beans by count;
- The cocoa beans contain an average of more than 4 percent insect infested or insect damaged beans, by count; or
- 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 introducted 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 mamalian 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