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*:
Examination of six 50 gram subsamples shows:
1. Insect fragments - an average of 75 or more insect fragments per 50 grams;*
2. Rodent Hairs - an average of 1.0 or more rodent hair per 50 grams.
*NOTE: These criteria do not apply to flour prepared from durum and/or red durum wheats.*
*The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) because it consists in part of a filthy substance by reason of the presence therein of insect fragments and rodent hairs.
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 also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."*
*Material between asterisks is new or revised.*
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.