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 canned berries contain an average of 40 or more thrips per No. 2 can and 20% of the subs are materially infested.
Article 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)(3), in that it consists in part of a filthy substance by reason of the presence therein of thrips.
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.
1Winton & Winton "Structure and Composition of Foods," Volume II, 1935.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 11/1/81, 3/95
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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