REGULATORY ACTION GUIDANCE
The following represents criteria for recommending direct reference seizure to *Chief Counsel* through Division of Compliance Management and Operations, HFC-210, by district offices:
- The articles are packaged in retail packages of the type and size ordinarily expected to be taken into the home where microorganism contamination of food, cooking and eating utensils, food preparation surfaces or hands could occur,
- well documented 402(a)(3) and/or (a)(4) violations of rodent contamination exist through gnawings, urine stains or excreta pellets.
- Analysis for microbiological contamination should not be done; 402(a)(3) charges may be based upon adequate evidence of contamination by rodent pellets, urine or other filth which has been verified by appropriate laboratory examination.
- Criteria for seizure may be applied to either single or multiple lots.
- These criteria apply only to rodent contaminated products. Bird and other contaminations of pet foods must be approved through the *Center.*
Article adulterated while held for sale after shipment in interstate commerce within meaning of 21 U.S.C. as follows: 342(a)(3) in that it consists in part of a filthy substance by reason of presence therein of rodent urine and rodent excreta pellets; and 342(a)(4) in that it has been held under insanitary conditions whereby it may have become contaminated with filth.
Article adulterated while held for sale after shipment in interstate commerce within meaning of 21 U.S.C. 342(a)(4) in that it has been held under insanitary conditions whereby it may have become contaminated with filth.
NOTE: See CPG 7103.01 (See Sec. 580.100 for CPG 7103.01) for cases involving human food storage and warehousing.
*Material between asterisks is new or revised*
Revised: 3/95, 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)
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