The following represents criteria for direct reference seizure *request 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. Insect filth - The wheat contains an average of 32 or more insect damaged kernels per 100 gms;
2. Rodent excreta - The wheat contains an average of 9 mg or more rodent excreta pellets and/or fragments of rodent excreta pellets per kg;
3. Plugging - There is clear-cut evidence of uneven loading or plugging, and wheat from any identifiable portion of the load meets the above criteria for insect damaged kernels or rodent excreta pellets.
*The article was adulterated (when introduced into) (while in) (while held for sale after shipment in) interstate commerce within the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a filthy substance by reason of the presence therein of insect damaged wheat kernels, insects, insect fragments, rodent hairs, and rodent excreta fragments, as applicable.
1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce"
2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce"*
*Material between asterisks is new or revised.*
Issued: 10/11/79 Revised: 10/1/80, 6/6/88
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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All comments should be identified with the title of the guidance.