REGULATORY ACTION GUIDANCE:
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*:
The sample of cheese products was processed from reject quality milk tested during an establishment inspection, even though filth is not found in the sample.
Reject quality milk is determined as follows:
1. The sediment factor for 12 mg. and 6 mg. sediment pads exceeds 10. (Add the sum of the percentages for sediment pads graded as 12 mg. and 6 mg.),
2. The sediment factor for 12 mg. and 6 mg. sediment pads is 8 or more, determined as above, and the sediment factor for 12 mg., 6 mg., and 3 mg. sediment pads is 30 or more. (Add the sum of the percentages for sediment pads graded as 12 mg., 6 mg., and 3 mg.).
Cans of milk with 2 or more flies are considered reject as are cans of milk from which 6 mg. and 12 mg. sediment pads are obtained.
The presence of manure fragments, insects, insect fragments or rodent hairs must be established by laboratory examination *(using the method described in AOAC XV Ed. 952.21)* of some of the 3 mg., 6 mg., and l2 mg. sediment pads to confirm the classification and show that reject quality milk was used.
Article (cheese) (cheese product) adulterated (when introduced into and while in interstate commerce) (while held for sale after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(4), in that it has been prepared under insanitary conditions whereby it may have become contaminated with filth. It was processed from reject quality (filthy) milk.
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 11/1/81 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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