The following represents the 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*:
If upon examination of 10/225 gm subs or 6/10 oz. consumer size packages one of the following conditions is met:
1. One or more rodent excreta pellets are found in one or more subs and one or more rodent hairs are found in a least two other subs.
2. Examination shows two or more rodent hairs/lb., and rodent hair are found in 50% or more of the subs.
3. Examination shows 20 or more gnawed kernels/lb., and rodent hair are found in 50% or more of the subs.
4. Examination shows 5% or more by weight of field corn.
The article was adulterated when introduced into and while in interstate commerce, 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) in that it consists in part of a filthy substance by reason of the presence therein of rodent excreta pellets, rodent hair, and by reason of being rodent gnawed.
If the adulteration is due to the presence of field corn, cite, "within the meaning of 21 U.S.C. 342(b)(2) in that field corn has been substituted in part for popcorn."
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."
3. Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 10/1/80 Revised: 7/1/83, 12/8/88, 8/96
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.