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 by the appropriate Field Office within the Human and Animal Food Program*:
1. Insects and Mold - an average of 10 percent or more by count of green coffee beans are insect infested, including insect damaged, or moldy;
2. Graded green coffee beans are poorer than Grade 8 of the New York Green Coffee Association.
NOTE: Criteria for direct reference seizure are determined using the method specified in FDA Technical Bulletin Number 5, "Macroanalytical Procedures Manual," Chapter V.1.A - Method for Coffee Beans.
If live external infestation is present use the CPG titled "Food Storage and Warehousing - Adulteration - Filth" (See Sec. 580.100 for CPG 7103.01) in accordance with "Interpretation of Insect Filth" (See Sec. 555.600 for CPG 7120.18).
Article (Green Coffee Beans) adulterated (when introduced into and while in interstate commerce) (while held for sale after shipment in interstate commerce), within the 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 fragments), and (insect damaged green coffee beans); and that is consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed green coffee beans).
NOTE: Psocids, as well as other non-storage insects not normally associated with green coffee beans, are to be reported separately from live whole insects or equivalent. The presence of such incidental non-storage insects in a lot of green coffee beans does not meet the criteria for direct reference seizure under this guide or the guide for food storage and warehousing. Any regulatory action based on the presence of such incidental non-storage insects must be referred to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for coordination and review.
*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
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