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 - The corn meal contains an average of 1 or more whole insects or equivalent/50 gms. (0.5 or more whole insects or equivalent/25 gms.);
2. Insect fragments - The corn meal contains an average of 25 or more insect fragments/25 gms.;
3. Rodent hair - The corn meal contains an average of 1 or more rodent hairs/25 gms.;
4. Rodent excreta - The corn meal contains an average of 1 or more rodent excreta fragments/50 gms.
*The article was adulterated (when introduced into) (while in) (while held for sale after shipment in) interstate commerce within 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 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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Rockville, MD 20852
All comments should be identified with the title of the guidance.